Human Subjects and IRB: Resources

All research projects with human subjects conducted by faculty, staff and students associated with Stevens Institute of Technology must receive approval from the Committee for the Protection of Human Subjects (CPHS). CPHS is the name for the Institutional Review Board at Stevens responsible for reviewing and monitoring human subject research and its compliance with regulations issued by the Office of Human Research Protections (OHRP).

For more information about basic ethical questions in the conduct of research, you are encouraged to read the Belmont Report. 

A brief review of relevant documents is provided here to help investigators better understand the reason for ethical review of research involving human participants, the primary ethical principles that govern such research, and the statutory basis for enactment of these principles. This Handbook contains information that should assist Stevens’ researchers in the preparation of an acceptable application for review of a project that involves human subjects.

1.1 Historical Significance of Human Subject Research
The history of research involving human participants includes multiple instances of inhumane and unethical treatment.

The Nuremberg trial documents one such episode involving the unethical behavior of German doctors and scientists during World War II.

The United States possesses its own history of abuse. The worst example of human subject violations in the United States was the Syphilis Study conducted in Tuskegee, Alabama by the U.S. Public Health Service from 1932 to 1972. Approximately 400 poor, mostly illiterate, African American men were enrolled in a study designed to follow the natural course of syphilis.  There was no informed consent process, they were not informed that they had the disease nor were they offered any treatment after penicillin was found to be effective cure in the mid 1940’s.

In another example, children at the Willowbrook State School, a New York state school for “mentally defective” youths, were purposely infected with the hepatitis virus between 1963 and 1966. During this time, the school claimed they were overcrowded and closed the school to enrollment of new clients.  Parents were allowed to enroll their child only if they agreed to allow their child to participate in the research project.

Behavioral and social science researchers have exposed other humans to severe trauma and psychological stress in the name of scientific research. The participants in Stanley Milgram’s studies on obedience in the early 1960s were told that continued participation in the study required that they shock another person at increasingly intense voltages.  Participants were unaware that the third party was actually a collaborator who was “faking” a reaction to electrical shock.

1.2 Codes of Research Ethics
Codes of research ethics have been developed to address the disregard for human safety and dignity reflected in the aforementioned projects.

The Nuremberg Code of 1947 was the first international code of research ethics. The first principle established that “The voluntary consent of the human subject is absolutely essential.” The code clarified that the potential subject should “...have the legal capacity to give consent” and “...should have sufficient knowledge and comprehension ... to make an understanding and enlightened decision.”  This basic concept continues to serve as the foundation for ethical research involving human participants.  Other codes followed.  In 1964, the World Medical Association adopted the Declaration of Helsinki.  This code established the concept of ethical review by an independent board. It also recognized a distinction between therapeutic and non-therapeutic research. The American Psychological Association established the first ethical code addressing social and behavioral research in the U.S. in 1972. Based on examples of unethical or questionable behavior, the APA developed ten basic principles for human subjects’ research. These principles were the first to recognize the principle of confidentiality.

Today, most professional organizations have ethical codes that provide guidance on human subject research. Also, many journals now require that authors state adherence to appropriate ethical principles and guidelines in their research.
The U.S. Department of Health, Education and Welfare (DHEW) issued ethical guidelines in 1971 through the National Institutes of Health.  In 1973, an ad hoc advisory panel issued the final report of the Tuskegee Syphilis study.  This report concluded that, “Society can no longer afford to leave the balancing of individual rights against scientific progress to the scientific community.”  The following year, Congress passed the National Research Act and codified the DHEW guidelines into federal regulations at 45 Code of Federal Regulations (CFR) 46 (also known as the Common Rule).  The Act also established the National Commission for the Protection of Human Subjects to identify the basic ethical principles that now underlie the conduct of biomedical and behavioral research involving human subjects. Known as the Belmont
Report, the report was published in 1978 and identified three basic ethical principles:

• Respect for Persons (autonomy) – This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from all potential research subjects (or their legally authorized representatives).
• Beneficence – This principle requires the investigator to maximize the benefits and minimize the harms or risks associated with the research. Research-related risks must be reasonable in light of expected benefits.
• Justice – This principle requires equitable selection, recruitment and fair treatment of human research subjects.

These three principles were the underpinnings of the Common Federal Policy for the Protection of Human Subjects. Sixteen federal departments and agencies, including the Department of Health and Human Services, the National Science Foundation, The Department of Education, and the Department of Energy, have adopted the current version. The current version was published in 1991 and guides the decisions of CPHS. The regulations further require that every institution at which federally funded research is conducted adhere to the principles of the Belmont Report and set forth in writing its ethical principles, policies, and procedures. Stevens’ agreement to abide by the Belmont Report and by 45 CFR 46 (called a Federalwide Assurance) is approved by the federal agency that oversees ethical issues in human research.

Stevens is committed to following and complying with the requirements set forth in the regulations for the protection of human subjects at 45 CFR 46.

1.3 Administration of Research Ethics – Federal
The Office for Human Research Protection (OHRP) is the federal office responsible for the oversight of research involving human participants and is part of the Department of Health and Human Services.

Audits conducted by OHRP at several institutions have resulted in the temporary suspension of all research activities involving human subjects.

1.4 Administration of Research Ethics – Stevens Institute of Technology
The key institutional leader responsible for oversight and management of all aspects of Stevens’ research is the Provost. The Provost, who is responsible for the administration of research ethics at Stevens, has the authority and responsibility to establish, maintain and oversee the protection of human subjects at Stevens Institute of Technology.  The Provost is the designated institutional official for human research protection in SIT’s Federalwide Assurance with the DHHS.  

The Provost oversees the Office of Sponsored Programs, which provides administrative support for the Committee for the Protection of Human Subjects (CPHS).  The primary administrative responsibility for the day-to-day operation for the protection of human subjects lies in the Office of Sponsored Programs (OSP) under the Director of Research Data, Audit and Compliance, which is part of the Office of Sponsored Programs.

For additional information, visit the OSP web site click on “Compliance > Humans / IRB.”

1.5 Committees for the Protection of Human Subjects Authority
The CPHS plays a primary role in protecting human subjects involved in research at Stevens by:

• reviewing new and continuing human subject research protocols through the evaluation of risks and benefits to the human subjects,
• reviewing the adequacy of the informed consent document, particularly as to its description of the risks and benefits,
• observing and monitoring ongoing research as is necessary to protect human subjects;
• investigating and acting on allegations of non-compliance and
• suspending or terminating approval of previously approved research when necessary.

Although the Provost, deans, department chairs and other University officials may have the authority to disapprove research activities approved by the CPHS or to set more stringent requirements on research protocols, research disapproved by the CPHS cannot be conducted.

2.1 CPHS’ Charge
The scope of CPHS’ charge is broad. Generally, any University research that involves humans, human tissue, surveys of human subjects, or human subjects’ records requires CPHS review and approval, regardless of the funding source. This purview extends to all student research projects. The specific charge to the CPHSs is to give consideration to:

• the potential risks to the subjects;
• the anticipated benefits to the subjects and others;
• the importance of the knowledge that may reasonably be expected to result; and
• the informed consent process to be employed.

The basis for the CPHS charge is found in the Code of Federal Regulations (CFR). Although protection of human subjects is a concern of all agencies that sponsor research, regulatory leadership is vested in the Office for Human Research Protection (OHRP) and the Food and Drug Administration (FDA).  The OHRP has general responsibility for the protection of humans as subjects in research, and the FDA regulates the use of drugs and medical devices in experiments.

OHRP regulates compliance of institutions primarily through “Assurances.” A Federalwide Assurance (FWA) is a legally binding agreement between the University and the OHRP. The University’s assurance outlines our responsibilities and explains the steps the University will take to meet the federal regulations for research on human subjects. Stevens’ Federalwide Assurance with OHRP states:

“This Institution assures that whenever it engages in human subject research conducted or supported by any federal department or agency that has adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule, the Institution will comply with the Terms of The Federalwide Assurance for Institutions.  Within the United States, unless the research is otherwise exempt from the requirements of the Common Rule or a department or agency conducting or supporting the research has determined that the research shall be covered by a separate Assurance.  This Institution elects to apply the following to its entire human subject research regardless of source of support:  The Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR Part 46.”

2.2 Membership and Structure of the CPHS
Stevens’ Committee for the Protection of Human Subjects is composed of eight members.   Included are the Chair, one representative from each of the four schools/colleges, one community representative, one non-science representative, an ex officio appointment of the Executive Director of Sponsored Programs and one graduate student representative.  Additional participants may be appointed if the required expertise is not available on the CPHS (i.e., the additional membership required to review research involving prisoners, for example).  These individuals may participate in a temporary way in order to provide particular expertise not resident in the committee composition; or, the committee composition may be expanded to include an additional member, or members, if recurring research protocols indicate sustained growth in a particular discipline.  If an individual participates in a temporary/one-time/occasional manner, their presence will not count toward fulfilling the quorum requirement. 

In accordance with 45 CFR 46.110(b), the CPHS has a related subcommittee consisting of the chairman and one other committee member. The subcommittee can only review research activities that fall under one of the exempt or expedited categories published in the Federal Register (63 FR 60364-60367, November 9, 1998). The list is also provided on the CPHS web site.

The committees strive for a balance of men and women and representation from diverse ethnic groups (§46.107(a)).  Appointment is based on the expertise required, familiarity with applicable laws, regulations, and relevant standards of professional conduct and practice, and knowledge of vulnerable or special populations. Diversity in experience and expertise enables the CPHS’ to evaluate a wide range of research.

2.3 Research Data, Audit and Compliance (R-DAC)
OSP’s Research Data, Audit and Compliance is part of the Office of Sponsored Programs and provides administrative support to the CPHS.  Specifically, the OSP Compliance Specialist/CPHS Coordinator reviews protocols for accuracy and completeness prior to them being assigned to a reviewer and acts as a liaison between the principal investigator and the CPHS members.  The CPHS Coordinator and other R-DAC staff regularly attend professional society meetings in order to remain knowledgeable regarding all regulatory implementations and/or changes that pertain to human subjects’ research and to serve as a resource and subject matter expert.

2.4 CPHS Meetings
Convened meetings are scheduled monthly, September to August.  The schedule is set in the summer for the following academic year and published on the ‘Human Subjects’ section of the OSP web site.  The deadline for submission of materials for full CPHS review is two weeks prior to the scheduled meeting. Members are sent applications and other materials for review approximately one week prior to the scheduled meeting. Prior to the meeting, members are expected to thoroughly review all materials for which they are an assigned reviewer and should have reviewed and be prepared to discuss all other protocols.

The CPHS meets in executive session. When given adequate notice and if the agenda and time permit, the Chair may permit persons not affiliated with the CPHS to attend meetings.  Investigators or their collaborators are not permitted to be present at CPHS meetings during deliberations on their research. However, the CPHS may decide to invite investigators to the meeting to answer questions about their research.

Except when an Expedited Review Subcommittee procedure is used (46.110), review of proposed research will be done at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.  In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting. (45.CFR 46.108 (b))

2.5 CPHS Policies
The CPHS’s policies are drafted by the CPHS chairs, or designees, and approved by a majority of members present at a convened CPHS meeting at which a quorum is present. The policies may be changed or revised as warranted by the majority of the CPHS at a convened meeting.

When warranted and appropriate in specific situations, the CPHS may waive any of its policies and procedures if: (1) the waiver is not inconsistent with federal regulations and (2) the waiver does not increase the risks to participants in research

2.6 Conflict of Interest
No CPHS member may participate in the review of, or vote on, any initial or continuing application, revision, or other matter involving research in which he or she has a conflict of interest (§46.107(e)). A conflict of interest is assumed to be present when the CPHS member is the Principal Investigator, faculty sponsor, or member of a funded project on any research being reviewed by the CPHS or when the member has a financial interest in the sponsor of research under consideration.

Members shall excuse themselves from discussions at CPHS meetings of an application or other matter in which they have a conflict of interest. This is recorded in the minutes. Members may provide information requested by the CPHS prior to or after formal deliberations.

The Chair excuses him- or herself from reviewing applications for expedited review and revisions or continuations when a conflict of interest is present. The Chair may appoint another CPHS member to act as chair during the review of such applications or research activities. This is noted in meeting minutes indicating the CPHS’s actions.

All CPHS members are encouraged to avoid the appearance of a conflict of interest that would compromise their ability to make a fair, impartial, and ethical decision on any CPHS matter and to excuse themselves from decision-making in such instances.

3.1 Definition of Research
Research is defined by the federal regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)]  This definition may include qualitative and quantitative research studies, surveys, case studies, experiments, interventions, analysis of specimens, demographic and epidemiological research, program evaluations, oral histories, secondary analyses of documents and records, and other methods associated with biomedical, behavioral and social sciences.  Research is characterized by the intent to share knowledge with others in professional, scholarly, or scientific publications and/or forums.

3.2 Definition of a Human Subject
A human subject is defined in the federal regulations as a “living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]

Student Projects
Stevens supports a wide range of both undergraduate and graduate student research projects using human subjects -- from course-related research exercises to Ph.D. dissertation studies.  Generally, student research involving human subjects falls into one of two categories:
RESEARCH PRACTICA, the goal of which is to provide research training.  Research Practicum is a course of study that involves the supervised practical application of previously studied theories of research method (based on Webster's New Collegiate Dictionary).  A number of departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these course projects is to train students and provide them with a closer view of social, educational, or psychological processes, and an opportunity to practice various research methods.  Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Therefore, the IRB does not consider them to be research and IRB review and approval is not required.  See Section 3.7 “Research Conducted in University Courses” for additional information and discussion. 
Although the IRB does not review such class projects, we strongly encourage instructors to become fully familiar with each student's project(s), and to discuss it with the student.  Experience indicates that time spent with students discussing matters such as courtesy, and avoidance of unnecessary discomfort or invasion of privacy, will be time well spent.  We believe that explicit recognition of the existence of Human Subjects Review Boards at all research institutions, and discussion of their goals and concerns, should be an integral part of introducing students to research methodologies.
DIRECTED OR INDEPENDENT RESEARCH PROJECTS (e.g., undergraduate honors or graduate theses), which employ systematic data collection with the intent to contribute to generalizable knowledge.  These are research projects and do require IRB review and approval.  If you have questions regarding the distinction between these categories, please do not hesitate to contact the CPHS Coordinator for assistance.

Pilot Studies
As the IRB interprets the concept, a PILOT STUDY is a preliminary investigation of the feasibility of a study, usually done on a small scale (fewer than 10 subjects) and exploratory in nature.  It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design.  At the point of academic discussions, e.g., "how could this survey question be misunderstood," such a pilot would not contribute to generalizable knowledge.  It is not considered research and does not require IRB review;                                                                                                                                                                                          
HOWEVER………………….
The IRB has encountered cases in which information derived from pilot studies has been considered or used for research purposes, i.e., publication. The IRB urges investigators preparing pilot studies to weigh the likelihood that the pilot data will actually be used for research purposes. Additionally, the Veterans Administration (VA) does not recognize the concept of ‘pilot projects’ and requires IRB review for ALL human subject interaction.  In those instances, IRB review and approval is required before data collection commences.
Oral History
ORAL HISTORY is a technique in which the researcher conducts a series of taped interviews with the participants in a particular historical event or period. Often, the intention is that these tapes become available to the public at a specified future time (frequently after a substantial delay) in order to convey historical insight.
In many cases, these interviews will be historical recollections of the character of a society or an institution rather than the interviewee's subjective perceptions.  Such activities may or may not be considered human subjects research.  While the IRB is eager to avoid interfering inappropriately with the researcher's or interviewee's freedom of expression, oral history projects should be submitted to the IRB to determine the appropriate level of review.  (In many cases, these projects may meet the requirements for Exempt Review Procedures.)
Special considerations for oral history projects include:

• • Are the conditions of use or publication of the recording clearly understood in advance by the interviewee?
  • Is the interviewee given an opportunity to provide effective consent to the interview?
  • Are adequate means provided for the protection of the privacy of any third parties who may be named in the interview?

Third Parties
In the course of their research, investigators sometimes collect information about persons other than the participant who has provided informed consent to be part of a study.  For example, medical histories often collect information about conditions and diseases among a person’s relatives.    Sociological, anthropological, or psychological research may obtain information about people’s experiences and perspectives on others in their lives.  Persons who are not primary subjects of research, but about whom information is collected are sometimes referred to as “third parties” or “secondary subjects.”  Many CPHSs and the OHRP have examined the issue of: when do third parties become “human subjects” from whom informed consent must be obtained?

Investigators have an ethical responsibility to avoid exposing any persons to unnecessary risks or undue harm, whether or not they are research subjects.  Information collected about third parties generally should be recorded in a manner that protects their identities, and special steps must be taken to safeguard confidentiality in the case of sensitive information that could cause harm to persons unless this jeopardizes the rights and welfare of the research participants.

The CPHS will consider on a case-by-case basis the circumstances under which third parties should be considered research subjects.  In reaching this determination, the CPHS will consider the following factors: (1) the amount of private information collected about third parties; (2) the sensitivity of that information; (3) the ability of investigators to maintain the confidentiality of third parties; (4) the welfare of the originally designated research subjects; and (5) the right of the originally designated research subjects to provide information on their personal life experiences.  Third parties normally are not considered research subjects from whom consent must be obtained unless information obtained about them pertains to their personal behavior unrelated to the interests and experiences of the originally designated research subjects.

Expert Opinion
Faculty, staff and students sometimes solicit the opinions of experts through phone or face-to-face interviews, surveys, and IRB discussions.  Experts are persons who, by virtue of their training or expertise, have information and knowledge in a substantive area beyond that of the average person and who regularly share this information and knowledge through consultation, teaching , public speaking, or publications and written reports.  For CPHS purposes, experts are not human subjects when asked to provide information and opinions within their areas of expertise.   Communications with experts on non-private information do not require CPHS approval;

However………

The CPHS has encountered cases in which information derived from experts has been used for research purposes, i.e., publication at which point it does become subject to 45 CFR 46.  If you have questions regarding the distinction between these circumstances, please do not hesitate to contact the CPHS Coordinator for assistance.

Autobiography or “Auto-ethnography”
In sociology, anthropology and related disciplines, postmodern ethnography, autobiography, or auto-ethnography is a narrative method in which the investigator and “subject” are one and the same.  That is, the investigator reports on his/her own experiences and perspectives.  In this form of narrative reporting, the investigator is not considered a research subject, and CPHS approval is not required.

3.3 Scope of Review
CPHS review and approval is required for any research involving human subjects that:

• is conducted by University faculty, staff, or students;
• is performed on the premises of the University;
• involves University students, faculty, or staff;
• satisfies a requirement imposed by the University for a degree program;
• is performed with, or involves the use of, facilities or equipment belonging to the University.

3.4 Research Conducted by “Affiliated Faculty”
Research conducted at Stevens  by “affiliated faculty” – faculty members who hold appointments in other departments or at other universities– is subject to the University’s guidelines for research on human subjects and must be submitted for CPHS review.   Any research project that is conducted by or under the direction of any employee or agent of this institution, in connection with his or her institutional responsibilities, requires CPHS approval.

3.5 Research Projects in which the Researcher is a Consultant
University CPHS review is required as stated above unless the researcher has a strict consulting relationship in which:

• the researcher is hired on his or her own time; OR
• the researcher holds no rights in the work; AND
• neither the researcher nor the University retains any data;  and the researcher does not utilize University space, materials and supplies, and secretarial and staff support.

3.6 Research Conducted by Students – The Faculty Sponsor’s Responsibility
Theses/dissertation projects, senior honor theses, independent study research projects, and other similar projects must be submitted independently to the CPHS by the student-researcher.  Faculty sponsors must instruct students on the ethical conduct of research and help them prepare the application for CPHS approval.  Students should:

• understand the elements of informed consent;
• develop a readable consent form following the samples
• plan appropriate recruitment strategies for identifying potential subjects;
• establish and maintain strict guidelines for protecting anonymity or confidentiality; and
• allow sufficient time for CPHS review and completion of the project.

To ensure that the University’s guidelines will be followed, the faculty sponsor is required to sign the student’s application for CPHS approval.  The faculty sponsor’s certification section of the application states, “I hereby certify the accuracy of this application and attest to the scientific merit of the proposed project.  I accept the responsibility for the conduct of this research and for the protection of human subjects as required by law and institutional policy.”  After CPHS approval, faculty sponsors must take an active role in ensuring that projects are conducted in accordance with the CPHS’s requirements.

3.7 Research Conducted in University Courses
Many research methods courses at Stevens require students to complete projects as a way of teaching research methods and skills.  Institutional review boards at institutions of higher education vary according to whether they require student projects to be reviewed and approved.  Stevens CPHS does not require student projects conducted in research methods courses to be reviewed if the purpose of these projects is educational in nature and will not be published or used in future research.  Activities not intended to provide generalizable knowledge are not subject to CPHS review.  However, the instructor of the course is ultimately responsible for the protection of human subjects.  Students are not permitted to continue projects conducted for a research methods course after the semester has ended, or to use data collected during the course, without CPHS approval.

Students in graduate methods courses, in particular, sometimes use projects to refine their research interests and provide a foundation for a thesis or dissertation.  This type of research would require CPHS approval if human subjects are involved.  A project initially conducted to learn research methods may yield data that the student subsequently wishes to use to contribute to knowledge. In order to use this data for theses, dissertations, or other research purposes, students must either: (1) demonstrate that individuals provided informed consent for the project at the time, through procedures approved by the instructor; or (2) obtain consent from the individuals to use previously collected information according to procedures approved by the CPHS (i.e., an application for exemption, expedited review, or full CPHS review).  Instructors of methods courses requiring student projects are required to send a memo to the CPHS administrator listing the students and their research projects and indicating that the projects were conducted under the instructor’s supervision and in accord with procedures approved by the instructor.  The administrator will provide a memo verifying that the student projects did not require CPHS approval.

Student projects in courses are subject to CPHS review if they are designed at least partially to provide data for research and publication purposes.  For example, instructors may enlist students to assist in data collection or analysis for their own research or may design seminars in which a goal is for students to collaborate in research that will be submitted for publication.  These projects constitute research and must be submitted to the CPHS for approval before the project can begin.

3.8 Research Conducted at Another Institution
Prior to participation in a research project at another institution, the University-researcher must obtain approval of the project by the relevant CPHS at Stevens and all relevant institutions.  For example, a University researcher engaged in research with Rutgers must secure approval from the CPHS at Stevens and the IRB at Rutgers, unless a Memorandum of Understanding recognizing each other’s IRB is in place.

Changes in protocol or consent forms required by the IRB at the other institution must be brought to the attention of the CPHS at Stevens.

3.9 Research Conducted at Stevens by Investigators from Other Institutions
Stevens’ officials and faculty are sometimes approached by investigators at other institutions for cooperation in their research.  For example, department chairs or deans might be asked to assist in the distribution of surveys to faculty or students.  This research does not fall under the purview of the CPHS unless: (1) University facilities and resources will be used; (2) University officials are actively engaged in or actively cooperate with or encourage participation in the research; or (3) University officials, faculty, staff, or students intend to use the findings or results of these studies for their own purposes.

Investigators from other institutions are advised to contact the CPHS Coordinator at 201.216.5280 for information on the required procedures.

3.10 Research as Part of Multicenter Clinical Trials
Approval of a proposal document at the national level is not sufficient to bypass approval at the local level. Researchers who conduct multicenter clinical trials sponsored by the National Institutes of Health (NIH) or the National Cancer Institute (NCI), for example, should include protocols and consent forms approved at the national level with their applications to the CPHS.  Although the documents should be identified as having been approved by a national CPHS, the local CPHS must review the material as it would any other submission.

Only the local IRB is vested with the authority to review and approve projects to be conducted at a given institution familiar with the particular circumstances of its research setting and is able to weigh critical considerations such as state and local laws, professional and community standards, institutional policies, and the needs of different patient and subject populations.

If changes are made to documents approved by the national IRB, the investigator must notify that IRB.  The University CPHS will rarely make substantive changes in the protocol or study plan and more likely to request that the wording of a consent form be changed to reflect local standards or to include specific language required by the University.

3.11 Research in Foreign Countries
Research conducted by University investigators in foreign countries remains under the purview and guidelines of the University CPHS.  While we cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct or consent process.

While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place.  Different traditions, mores and institutions may require different research protocols, particularly regarding informed consent, recruitment practices, and documentation. Special attention must be given to local customs, culture, and religious norms in drafting written consent documents.

Documentation of “local approval” is a prerequisite to CPHS approval at the University.  This approval should be from the local equivalent of the University CPHS, local experts or community leaders.  Researchers should provide sufficient information regarding the language and culture of the country in question. Researchers proposing international research should allow additional time for this review process.

3.12 Quality Improvement/Program Evaluation Research
Quality improvement (QI) activities may, but do not necessarily, constitute human research. QI attempts to measure the effectiveness of programs and services.  Such activity may constitute human research, if they are designed or intended to contribute to generalizable knowledge.  If they are designed solely for internal program evaluation purposes, with no external application or generalization, they do not require CPHS review and approval.

3.13 Research Involving Secondary or Archival Data
Federal regulations extend to the use of existing or “archival” data if it was originally obtained from persons who would meet the definition of a human subject.  Exempt category 4 states, “Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.”

This might include (but is not limited to) student test scores, academic achievement scores, attendance and/or discipline records, data previously collected in a research project, census records, etc.  The application must indicate that the data is publicly available (with a description of how it is obtained) or provide a letter from the person who is the owner or the keeper of the data indicating that permission has been granted for the use of the data in a research activity.  Also, the data must be in existence at the time the application is submitted to the CPHS.

3.14 Research Involving Tissue/Blood Samples
Research that is conducted on "waste" or "extra" human tissue or fluids must be submitted for review.  "Waste material" is material that is collected originally for clinical or diagnostic purposes only but is no longer needed.  "Extra material" is material that is collected above and beyond what is needed for a clinical or diagnostic procedure. It is collected during the same procedure, but solely for investigational purposes.

The CPHS may determine that research on waste material qualifies as exempt from full review.  If the subject's consent to the clinical procedure outlines research use of the material as well, a separate consent form may not be required. Collecting and using "extra material" requires subjects' written consent and full CPHS review.

3.15 Research Involving Deception
The CPHS discourages deception in any form of experimental procedure.  If an investigator believes that deception is necessary to conduct the research and is the only way to answer the research question(s), he or she must provide a detailed rationale to the CPHS and ensure that psychological, social, and other risks will be minimized.  Before approving deception in research, the CPHS will require a procedure to be put into place that provides for a debriefing process, with the participant being given a statement to sign indicating that debriefing has occurred and that he or she understands that deception occurred and how.

3.16 Research Involving the Internet
For Internet research, investigators must protect the privacy and confidentiality of participants and obtain their informed consent. Investigators may not be required to obtain consent of persons to record information or communications in public Internet forums in which people do not have a reasonable expectation of privacy.  For example, an investigator would need to obtain consent of people to record communications in a private listserv, but would not be required to do so in a public chat room with unrestricted access. In communications with persons in public or private Internet forums, investigators must not conceal their identities as investigators or mislead people about their purposes. Investigators must not communicate directly on the Internet with persons whom they believe are minors without their parents’ permission.  In an AAAS workshop on the topic of Internet research, workshop attendees provided a list of recommendations for improving “the quality of Internet research while promoting adherence to sound ethical research practices” and take privacy and information consent concerns into consideration. 

In electronic surveys or interviews, investigators must take reasonable steps to protect people’s privacy and confidentiality, taking into account the sensitivity of questions asked of them.  For interviews or surveys on non-sensitive topics, e-mail is generally acceptable. Interviews or surveys on sensitive topics should be conducted on a secure Web site.

In research protocols, university researchers should, at a minimum describe:

• The Internet methods and technology that will be used to interact with “Internet communities.”
• Potential risks and benefits of the research and how risks will be minimized.
• The informed consent process that will be used, i.e., how Internet community members will be informed that research data is being collected, how community members can ‘opt-out’ of having their data collected, etc. or justify why a waiver from the requirement to obtain informed consent is appropriate.
• The methods they will use to assure protection of privacy for subjects and how confidentiality of the data will be provided.

3.17 HIPAA and Research
The Health Insurance Portability and Accountability Act of 1996 was adopted with the goal of improving the efficiency and effectiveness of the healthcare system.  It also carries with it an associated Privacy Rule that can significantly affect the way researchers obtain, use and disclose protected health information (PHI) in research involving human subjects.
The minimum standard necessary requires that only the minimum amount of information needed for any specific purpose be used or disclosed. NOTE: HIPAA IS IN ADDITION TO, NOT INSTEAD OF, UNIVERSITY CPHS POLICIES. WHEN HIPAA AND HUMAN SUBJECT PROTECTION REGULATIONS APPLY, BOTH SETS OF REQUIREMENTS MUST
BE FOLLOWED.

Under certain circumstances, the Privacy Rule allows a covered entity to use or disclose PHI for research without an individual’s authorization.  Therefore, the CPHS’s role, under HIPAA, is to act on requests for a waiver or an alteration of the Privacy Rule’s Authorization requirement. The CPHS may grant a Waiver of Authorization for studies meeting ALL of the following criteria:

• The use or disclosure involves no more than minimal risk to a subject’s privacy, based on at least the following principles:
• A plan to protect identifiers
• A plan to destroy identifiers at the earliest opportunity that is consistent with the goals of the study, unless there is a health justification for retaining identifiers or retention is otherwise required by law
• Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by the study or law enforcement agencies.
• The research could not be practicably conducted without the waiver.
• The research could not be practicably conducted without access to and use of PHI. 

If a waiver is obtained, please note that the following procedures must also be in place:

• The investigator must identify and justify what identifiable information is needed.
• Disclosures of PHI outside Stevens must be tracked. The purpose of this tracking requirement is to provide patients, upon their request, with a list of where information about them was released for research and certain other non-treatment purposes without their knowledge.  The following information must be tracked for each disclosure:
• Name of individual
• Date of disclosure
• Name of person/entity that received the information
• Brief description of PHI disclosed
• Brief statement about the purpose of the disclosure
• Disclosures must be made available to the individual upon request for 6 years following the disclosure

Any changes to a waiver (for example, the addition of new sources of PHI) must be approved by the CPHS.

4.1 The CPHS Process
The CPHS reviews a protocol by first by assessing the risks and benefits of research participation. CPHS requires researchers to submit a “Stevens’ CPHS Application to Conduct Research Using Human Subjects.”  After determining that the research benefit outweighs the risks involved, the CPHS turns to the consent process to ensure that potential subjects are fully aware of the risks and benefits and that they are aware their participation in the project is voluntarily. The consent is a key element in the review.  The CPHS will also determine whether or not the scientific questions addressed in the protocol have adequate merit to justify the involvement of human subjects. 

After reviewing all materials, the CPHS may opt to approve, contingently approve (A), contingently approve (B), table, or reject/disapprove the application.  An application may also be withdrawn, either by the CPHS or by the investigator.  The CPHS may require revisions in the protocol.  After the investigator revises a project, the CPHS reviews the project again to see whether its concerns have been adequately addressed.

To fully protect subjects, the CPHS must approve a project before investigators start to work on it – even before they begin to recruit subjects, since recruitment strategies are part of the review.  Although there are different types of review, many projects require “full” committee review.  The initial full review will occur according the published submission deadlines.  All CPHS actions are communicated in writing to the investigator by the CPHS staff. If the investigator is a student, the notice is addressed to the investigator in the care of the faculty sponsor.

4.2 Primary Types of Review
The CPHS reviews research projects according to the risk to subject and at one of three levels defined in
federal regulations:

• Expedited (§46.101) – can be reviewed at either EXPEDITED SUBCOMMITTEE or FULL COMMITTEE meeting
• Exempt  (§46.101(b)(1–6)) -  can be reviewed at either EXPEDITED SUBCOMMITTEE or FULL COMMITTEE meeting.  It is important to understand that ‘exempt’ does not mean that an investigator is exempt from submitting a protocol for review.  ‘Exempt’ is a category (see 4.5 of this section for fuller discussion). 
• Full review – can be reviewed only at a FULL COMMITTEE meeting

The CPHS will determine the appropriate level of review at the time of protocol submission.   If a protocol is submitted for the EXPEDITED SUBCOMMITTEE deadline but does not meet the criteria for expedited or exempt review, it will be rescheduled for the next FULL COMMITTEE meeting.  The investigator will be advised if a protocol cannot meet the requirements of SUBCOMMITTEE review and must be moved to a full committee meeting. 

4.3 Full Review
A project that involves greater than minimal risk or does not qualify for exempt/expedited review requires
approval from an IRB composed of members qualified to review research in that field.  Research that requires full committee review includes:

• research that involves greater than minimal risk;
• non-exempt research that involves children or other vulnerable populations;
• research that involves experimental drugs or devices;
• research that involves invasive procedures; and
• research that involves deception.

Survey research that involves sensitive questions or information about sexual practices or illegal behavior is subject to full review, in keeping with federal guidelines.  Additionally, any survey or interview that is likely to be stressful for the subject requires full committee review.  The CPHS Coordinator will make this determination.

The administrative staff screens all applications before they are assigned to a CPHS meeting agenda and assigned to a reviewer.  If incomplete, the application is returned to the investigator. The CPHS reviews only complete applications (see 4.1).  After review, the CPHS will act on the application. Possible committee decisions include:

• APPROVAL - approved as submitted;
• CONTINGENT APPROVAL (A) - approved with requests for changes that can be reviewed and issued FULL APPROVAL (if appropriate) by the CPHS Coordinator;
• CONTINGENT APPROVAL (B) - approved with requests for changes that can be reviewed by the EXPEDITED SUBCOMMITTEE and issued FULL APPROVAL (if appropriate) by the CPHS Coordinator
• TABLED - deferred pending receipt of additional information or major revisions, all of which must be reviewed by the FULL COMMITTEE;
• DISAPPROVED – the protocol must be reworked and resubmitted for a FULL COMMITTEE review; or
• WITHDRAWN – the protocol has been withdrawn from consideration, either by the CPHS or the investigator.

All non-exempt research is subject to continuing review at least annually [refer to 8.0 Continuing Review].

4.4 Expedited Review
To qualify for expedited review, a research project must be limited to the activities that are federally approved for expedited review and incur no more than minimal risk for participants, or be a minor change in previously approved research that involves no additional risk to the research subject.

1. Clinical studies of drugs and medical devices, only when condition (a) or (b) is met:
   • Research on drugs for which an investigational new drug application (21 CFR Part 312) is required. (*Note: research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.); or
   • research on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with cleared/approved labeling.
2. Collection of blood samples by finger stick, heel-stick, ear stick or venipuncture as follows:
   • (a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the   amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or
   • (b) from other adults and children (as defined by the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in this research, under the applicable law of the jurisdiction in which the research will be conducted), considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means.  Examples:
   • hair and nail clippings in a non-disfiguring manner;
   • (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
   • (c) permanent teeth if routine patient care indicates a need for extraction;
   • (d) excreta and external secretions (including sweat);
   • (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
   • (f) placenta removed at a delivery;
   • (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
   • (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
   • (i) mucosal and skill cells collected by buccal scaping or swab, skin swab, or mouth washings;
   • (j) sputum collected after saline mist nebulization.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
8. Continuing review of research previously approved by the convened CPHS as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or Investigational device exemption where categories two (2) through eight (8) do not apply but the CPHS has determined and documented at a convened meeting that the research involves no greater than minimal risk and additional risks have been identified. 

The researcher must demonstrate in the application how the proposed project activities fall into one or more of these categories.  To apply for expedited review, investigators complete the Application to conduct Research using Human Subjects and indicate that they are requesting expedited review in the appropriate section.

The CPHS Coordinator will ensure that all of the elements essential for review, including consent forms
and supporting documentation, have been submitted. The administrator will then forward the application for review and approval by either the CPHS subcommittee or the full committee, depending on the submission deadlines.

In accordance with 45 CFR 46.110(c), the applications approved under the expedited procedures by the subcommittee are reported to all members of the full committee. The full committee shall receive a copy of the minutes from the subcommittee meeting listing the protocols that were reviewed and the decision.

NOTE:  The expedited review procedure may not be used: a) where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject = financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal; or b) for classified research involving human subjects.

4.5 Administrative Review for Exempt Status
While research that involves only minimal risk to human subjects is sometimes exempt from full and annual CPHS review, it is still subject to initial review.  Investigators do not have the authority to determine whether research involving human subjects is exempt from full review.  Researchers must file an application requesting that the CPHS determine exempt status for a project. Exemptions are approved for a specific research project conducted by specific investigators.  Departments cannot receive blanket exemptions for unspecified research (e.g., surveys, public observations) to be conducted in the future.

1. Research conducted in established or commonly accepted educational settings, involving normal educational   practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of Departmentor Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefitor service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

The application form is available from the Office of Sponsored Programs or its web site. Copies of the written
consent form should be filed with the application or justification for a waiver of written documentation should be provided.   See 45 CFR 46.117.

The CPHS Coordinator will decide whether the project qualifies as exempt, and confirms the decision in writing.  If the project does not qualify as exempt, it will be submitted to the appropriate committee based on the posted Submission Deadlines.  Again, the investigator will be notified in writing.  Exemptions are approved for a maximum of five years after approval.  To continue research after that time period, investigators must submit another application and apply under the exempt category.

4.6 Appeal of CPHS Determination
Investigators who have been required to make revisions in their applications or whose applications have been disapproved may request further information regarding its reasons from the CPHS or may ask the CPHS to reconsider its decision.  Such requests must be made in writing and will be considered by the CPHS at the next convened meeting, if submitted according to the published deadline for submission of materials to the CPHS. At its discretion, the CPHS may invite investigators to meet with the CPHS or a subcommittee of the CPHS to collect additional information or to explain the reasons for its decision.  The CPHS will provide investigators with a written explanation of its reasons or its decision upon reconsideration. The CPHS’s decision will be final, and no further appeal can be made.

4.7 Application Forms and Original Signatures
All forms that an investigator must file with the CPHS to apply for review are available with specific instructions on the OSP Web at www.stevens.edu/osp  (then click on “human subjects”), or from the Office of Sponsored Programs.  The CPHS Coordinator or Director of Research Data, Audit and Compliance can help researchers determine which application is appropriate for a project. The forms available are:

• Application to Conduct Research using Human Subjects
• Application for Revision to a Currently Approved Protocol
• Application for Renewal

A signature page provides space for the signature of the principal investigator and co-investigators. An original signature certifies that the investigator will be actively involved in the research project and has made a commitment to protect the research subjects according to the federal regulations and institutional policies. Faculty sponsors must sign all student research proposals.  Department heads (or college deans) must sign all faculty, staff and student proposals. [Note: Signature from the department head (or college dean) is not required for applications requesting exempt approval.] Signatures must be original.

All other documents submitted to the CPHS (such as interim reports, requests for revisions, adverse events reports, renewal applications) also require original signatures.  Staff signatures will not be accepted.  The principal investigator remains ultimately responsible for the protection of subjects.  Finally, before submitting the application with original signatures, investigators must:

• retain a copy of all submitted materials for their own records; and
• attach the appropriate number of copies required:
• for full committee CPHS review – 1 original hard copy with original signature must be provided to the CPHS Coordinator for the institutional file.  Additionally, the investigator must submit a scanned electronic version of the application, appropriate consent documents, interview questions and/or questionnaires, and any additional information.   The CPHS Coordinator will route the scanned application and accompanying material to committee members
• for expedited subcommittee review – 1 original hard copy with original signature must be provided to the CPHS Coordinator for the institutional file.  Additionally, the investigator must submit scanned electronic version of the application, appropriate consent documents, interview questions and/or questionnaires, and any additional information.  The CPHS Coordinator will route the scanned application and accompanying material to committee members.

4.8 Preparing the Application
To submit a project to the CPHS for review, an investigator must complete the application form according to detailed instructions and enclose supporting material as required.

A fully complete application form will include:

1. an up-to-date version of the appropriate application form;
2. answers to every question on the form;
3. appropriate attachments to the application;
4. lay abstract describing the purpose of the study;
5. a description of the study population, criteria for inclusion/exclusion, the number of subjects, the process of identifying potential subjects, and any other plans related to the selection of subjects;
6. a description of the tasks that subjects will be asked to perform;
7. a full description of the anticipated risks and benefits of participating in the study;
8. an explanation of how risks will be minimized;
9. documentation of provisions to care for subjects in case of accident or injury (if applicable);
10. a full description of procedures for maintaining confidentiality;
11. a description of the process by which informed consent will be obtained from the appropriate individuals;
12. documentation of any required approvals or applications for approval from other committees and/or from cooperating agencies;
13. all supporting materials and documents, including protocol, interview schedules, solicitation letters, advertisements, and any survey instruments; and
14. appropriate original signatures, including the faculty sponsor’s signature for student research, and the department head/college dean (when applicable).

The application form will serve as background information for all future reviews of the study. For this reason, “see protocol” or “see attached” are not adequate responses to any application question.  The application is designed to provide the CPHS with sufficient information about the proposed research activity to make the following determinations prior to approval:

• Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose them to risks.
• Risks are reasonable in relation to anticipated benefits, if any, to participants and the importance of knowledge that may reasonably be expected to result.
• Selection of subjects is equitable.  In making this determination, the CPHS takes into account the purposes of the research and the setting in which the research will be conducted and is particularly cognizant of the special problems of research involving vulnerable populations, including children, prisoners, pregnant women, persons with impaired decision-making capabilities, and economically or educationally disadvantaged persons.
• Informed consent is sought from each prospective participant or the participant’s legally authorized representative and is appropriately documented.
• When appropriate, the research plans make adequate provisions for monitoring the data collected to ensure the safety of participants.
• When appropriate, there are adequate provisions to protect the privacy of participants and confidentiality of the data.
• For participants who are likely to be vulnerable to coercion or undue influence, additional safeguards are included to protect their rights and welfare

No form can address adequately the wide diversity of research at Stevens.  Principal investigators should use the form to convey the nature and specifics of the project proposed and attach appendices as necessary.

4.9 Designating the Principal Investigator
The CPHS recognizes only one Principal Investigator (PI) for each project.  The PI must be a faculty member, student or staff member at Stevens.  On research conducted by students, a faculty member must serve as the sponsor and assume responsibility for exercising appropriate oversight of the student’s research.

The PI, including the faculty sponsor in the case of students, must personally review and sign all applications, revisions, renewals, and other documentation submitted to the CPHS.  The PI is responsible for identifying key personnel involved in the conduct of research, monitoring their activities, informing the CPHS of proposed changes, adverse events, and responding in a timely fashion to inquiries or requests from the CPHS.

All official correspondence is addressed to the PI.  In the case of student researchers, correspondence is addressed to the student, in care of the faculty sponsor.  All correspondence is sent via email.

Any change in the PI or in the PI’s status that affects the project must be communicated to the CPHS.  [See section 6.2 Making Changes to Research Protocols.]

4.10 Summary of Proposal: Rationale and Methods
Investigators must provide a summary of their proposed research in non-technical terms.  Any risks associated with human research must be warranted, and hence, for research to be ethical, studies must have scholarly or scientific merit.  Any study that does not have the potential to contribute to knowledge or that is fundamentally flawed in its methods cannot be approved by the CPHS.  When research is not flawed, but could be strengthened in the opinion of CPHS members, the CPHS may provide recommendations to investigators that they may follow at their discretion.  Recommendations are different than design changes or requirements that are incorporated as part of a contingent approval, or are the reason a protocol is tabled or disapproved.

Investigators should summarize the rationale for the research, including the research questions the study is intended to answer or the knowledge to be contributed by the study in the lay summary.  This section should not be used to describe the methods in the proposed research.

Investigators must describe the nature of the intervention or interaction with potential participants or the nature of private information to be collected and analyzed.  Both the general methodological tradition (e.g., qualitative versus quantitative) and specific methods (e.g., participant observation, interviews, surveys) should be described. The CPHS examines applications to ensure that the research methods are appropriate given the research rationale and questions.

The investigator must provide information on specific procedures, the nature and number of interventions or interactions with participants, and the analytical procedures.  Researchers using participant observation or anthropological field work methods should be specific regarding where and among whom observations will be recorded and how they will identify themselves.  The CPHS discourages covert participant observation in which the investigator conceals his or her identity as a researcher and will require a clear justification for this approach. The investigator must demonstrate that the research could not be conducted overtly and that participants will not be harmed or exposed to undue risk.

4.11 Specifying the Number of Research Subjects
The application must specify the number of study subjects to be recruited and the number to participate, grouped by age, gender, and population diversity.  Exceeding the recruitment limits approved by the CPHS is a violation of the protocol.  The CPHS must give prior written approval for any increase in subjects.  This can be done through a revision request to CPHS.

The CPHS is charged with the protection of human subjects from the earliest contact for possible recruitment.  All subjects who go through the recruitment process screening must be accounted for, even if they fail or decline participation.  When calculating the number of subjects in research design, please include a number large enough to account for this group.  If it is difficult to predict how many subjects will be eligible or be attracted to a study, the optimum number should be specified.  Responses such as “don’t know” or “as many as we can recruit” to questions about the number of subjects are not acceptable.

Multicenter studies, in which data will be pooled and recruitment may vary, present a special problem for investigators. The application should provide information about the total picture, including both the number of subjects to be studied at Stevens or by other university researchers and information on overall recruitment goals.

4.12 Women and Minorities in Study Populations
Research benefits and burdens should be distributed fairly.  If an individual or group is denied access to a clinical trial that might be beneficial, or if some people are singled out to bear the burden of risks associated with a study, the requirement for fairness is not met.

In accordance with the policies of the National Institutes of Health, the CPHS requires applicants for federal funds to provide data regarding the subject populations by gender and minority group.  Studies with the potential to address issues relevant to both genders must recruit both genders, and include minority groups in a study population wherever feasible.  Researchers must justify the exclusion of any group of individuals. The CPHS makes exceptions if there is adequate scientific justification for exclusion, such as when a disease predominates in one gender or the focus of the research question is on a specific group.

4.13 Students or Employees as Research Subjects
Though the researcher must be careful to avoid potentially coercive behavior, the very nature of the relationship with the subject can create the appearance of coercion.  For this reason, researchers should be aware of the potential for coercion that exists when a research subject is also a student, employee, colleague, or subordinate of the researcher. Therefore, researchers should avoid using their own students or employees as research subjects.

If there is sound scientific reason to include their students, researchers should:

• ensure that students clearly understand that participation will not influence class standing, grades or other benefits under the control of the researcher.
• limit the use of extra credit points as a reward for participating; points should be used only when the research is closely tied to the course subject matter and should not raise a student’s grade by a whole grade letter (for example, from a B to an A).  Students should be offered an alternative assignment of a non-research nature that entails the comparable level of time as the research activity. Students who participate in part, but not all of the research should be offered partial credit for participation according to the amount of time spent (an alternative assignment comparable in time must be offered to enable students to receive full credit).
• avoid using class time to recruit subjects or complete study instruments. 

Researchers who select colleagues or subordinates as research subjects must be able to provide a rationale other than convenience for recruitment and must show that the recruitment method does not imply penalty or compromise by refusing to participate. Recruitment through bulletin board advertisements or by a third party is preferable.

A detailed description of how students and colleagues will be recruited and how coercion will be avoided must be included in the information submitted to the CPHS.

4.14 Children as Subjects
All research that involves minor subjects is subject to the application of 45 CFR 46 Subpart D.  In all cases, inclusion or exclusion of children is reviewed for appropriateness as defined in the regulation. 

In general, if research involves greater than minimal risk, children can be included in the study population only if there is direct personal benefit to the child. This restriction applies to research in both the health sciences and the social sciences. A research protocol that involves more than minimal risk and offers no potential benefit to the subject cannot include children unless all conditions of 45 CFR 46.406 are met.  Investigators claiming this provision in 45 CFR 46.406 should be prepared to provide justification.

4.15 Prisoners and Institutionalized Persons
All research that involves prisoners is subject to the application of 45 CFR 46 Subpart C.  Prisoners and other institutionalized persons should neither bear an unfair share of the burden of participating in research nor should they be excluded from its benefits to the extent that voluntary participation is possible.  Persons confined to institutions must not be selected as research subjects simply because they represent a convenient population to study. 

The CPHS recognizes the special vulnerability of prisoners and other institutionalized persons who live under the supervision and formal authority of others.  Prisons include jails, detention centers, and state and federal prisons. Institutions include psychiatric centers or mental hospitals, development centers for people with developmental disabilities, nursing homes, and similar facilities.  The CPHS requires that research involving prisoners and institutionalized persons have risks commensurate with risks that would be accepted by non-institutionalized persons and that any possible advantages accruing to individuals are not of such magnitude that their ability to weigh the risks and benefits of the research, given an environment of limited choice, is impaired.

Procedures for selection of research participants in prisons should be fair and immune from the influence of prison authorities or prisoners.  Investigators must ensure that participation of prisoners will not have bearing on decisions regarding parole, and prisoners will be informed of this.  In view of violates of privacy that may occur in prisons, investigators must also take appropriate steps to maintain confidentiality in such settings.

To carry out its responsibilities under Subpart C, the CPHS must appoint an additional committee member (if it appears that protocols involving prisoners and/or institutionalized persons are becoming more routine) or bring in an expert to advise and guide the committee and who serves as a representative for this population of research subjects.

4.16 Persons who are Impaired in their Decision-Making
The ethical principle of respect for persons requires respect for the autonomy of individuals and special protections for those with diminished autonomy.  Some persons may be limited in their competence to make informed decisions about their lives by virtue of mental, intellectual, or cognitive disabilities.  Although investigators should be sensitive to the possibility that persons with disabilities may have limited capacity to consent to participating in research, they must not presume incompetence simply because a personal has a disability diagnosis or label. Investigators must respect the autonomy of all persons unless there is clear evidence that they are incapable of decision-making.

For persons who have been formally adjudged incompetent and appointed a legal guardian, their guardians must provide consent for them to participate in research, with appropriate provisions for assent by the individual.  Some adults who are incompetent to make major life decisions by virtue of a disability have not undergone a formal legal proceeding.  In these instances, the CPHS may require that informed consent be provided by a parent, spouse, or other “next of kin” or by the assignment of an advocate or witness to oversee the consent process.

Persons with mental, intellectual, or cognitive disabilities must not be unilaterally excluded from participation in general research without justification.

4.17 Incentives for Participation
The CPHS reviews and approves incentives offered to subjects to participate in research.  Subjects cannot receive payment to assume risk, but can receive compensation for the time and inconvenience involved in participation. Incentives may include monetary payment, course credit, gift certificates, toys or educational materials for children, and other items or services.  Incentives must not be of such an amount as to result in undue influence or coercion on an individual’s decision to participate, especially in the case of persons who are indigent.  In addition, incentives must not be provided on a schedule that results in coercion or undue influence on an individual’s decision to continue participation. That is, incentives must not be withheld as a condition of an individual completing the research.  If an individual ceases their participation before finishing the study, payments or incentives may be prorated to reflect the time and inconvenience of the individual’s participation up to that point.

Payment to research participants must be arranged in a way that minimizes potential violations of privacy.  For example, investigators should try to avoid linking subjects to participation in sponsored research involving sensitive topics (e.g., HIV and AIDS, drug use).  

The CPHS discourages lotteries for the payment of research participants.   Incentives for participation in research are not considered as benefits of the research and should not be described as such on the CPHS application.

4.18 Advertising and Recruitment
Advertisements are part of the informed consent process and subject selection process.  Copies of all advertisements, such as flyers, newspaper ads, radio and television announcements, URLs, bulletin board tear-offs, and posters, along with an explanation of other methods of recruiting subjects, must be submitted to the CPHS.

Advertisements should be submitted with the application or as soon as the principal investigator decides to use them. The content of advertisements should be limited to:

• names of the investigators and the university identified by name along with contact information,
• purpose of the research,
• general eligibility criteria, and
• straightforward and truthful descriptions of potential benefits and risks and payment (if applicable).

Advertisements should include the word “research” and should not claim, explicitly or implicitly, that the research is treatment or is superior to any current practice.  Extravagant attention-getting devices such as extremely large, bold typefaces and dollar signs are prohibited.  Statements of payment should not be in larger type than the rest of the advertisement.  Advertisements should not pressure readers into participating.  All recruitment materials should include the statement:

ALL RESEARCH PROJECTS THAT ARE CARRIED OUT BY INVESTIGATORS AT STEVENS INSTITUTE OF TECHNOLOGY ARE GOVERNED BY REQUIREMENTS OF THE UNIVERSITY AND THE FEDERAL GOVERNMENT.  ANY QUESTIONS REGARDING MY RIGHTS AS A RESEARCH SUBJECT MAY BE ADDRESSED TO THE STEVENS  COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS AT 201.216.5280.

5.1 A Process – Not a Form
Since subjects retain the right to withdraw from a study, consent is an ongoing process.  It starts well before any forms are signed and continues until participation is complete. 

The informed consent process is different from the consent form.  The process involves meeting with a potential subject, determining whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation with that subject. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed.

If consent is to be informed, the subjects must genuinely understand the study.  Hence, researchers should strive to convey information to subjects, not merely disclose it to them.  Subjects should be able to demonstrate their understanding of the procedures, risks, and benefits of the study in which they are agreeing to participate.

5.2 When to Discuss Participation with Research Subjects
To achieve understanding, potential subjects should not be presented information all at once or only at the last minute. People need time to think about whether or not they want to participate. They may wish to discuss the decision with family, close friends, or religious advisors.  They should not feel rushed or coerced. They need time, especially if the information is disturbing or particularly complex, to digest the information and come to terms with it.

Information must be comprehensible.  Even highly educated people must have technical information presented in simple terms. The best method of expression will vary with the proposed population.  Researchers may explain a project involving psychology using discipline-specific technology when approaching students of psychology for example. Laypersons, however, should receive as simple and straightforward a presentation as possible and using language appropriate at the 8th or 9th grade level is advised.  Some of the suggestions offered here for writing comprehensible consent forms are also useful for preparing scripts for verbal consent processes and telephone scripts.

5.3 General Requirements of a Consent Form
Federal regulations for human research identify some information as “essential” to understanding any research project [45 CFR 46.116(a)&(b)].   At a minimum, investigators should:

• explain the purposes of the research;
• report the expected duration of the subject’s participation;
• describe the procedures to be followed;
• identify any procedures or products that are experimental;
• explain why the subject is eligible to participate;
• describe any foreseeable risks or discomforts that the subject might experience;
• describe any benefits to the subjects or to others that can reasonably be expected;
• disclose appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
• explain the confidentiality of any records that identify the subject;
• for research that involves physical contact or physical activity, explain whether compensation or medical treatment will be available if the subject is injured and provide referrals for further information;
• identify people who can answer questions about the research, including the principal investigator (and the faculty sponsor if the investigator is a student) and the institutional CPHS; and
• explain that participation is voluntary, that refusal to participate will involve no penalty or decrease in benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits. (Note: If the potential subjects are students, it should be clearly explained that their class standing will not be affected by their decision as to whether or not to participate in the study.)

In addition to this essential information, circumstances may require that researchers:

• explain conditions under which the investigator can remove people from the study regardless of their consent.
• explain any additional costs of participation in the study.
• discuss the consequences of, and the procedures for, withdrawing from the study.
• declare that research findings that could affect participants’ willingness to remain in the study will be disclosed to them.
• state the approximate number of people involved in the study.
• identify pilot or feasibility studies. Some subjects are willing to participate in a study that has a track record but are not willing to participate in a pilot phase of a study. Participants must be told if they are among the first people to receive the intervention or treatment.
• inform women of child-bearing age whenever a pregnancy test is part of the research protocol.  They must also be told whether such tests will be repeated during the course of a research project and whether use of contraceptives is a requisite to participation. Men, too, must be told if contraception is recommended for them.
• explain that a treatment or procedure might involve currently unforeseeable risks (including risks to an embryo or fetus, if a participant is or become pregnant).
• make clear whether the procedures or drugs used in a study are standard, standard but used in a non-standard manner, or experimental.
• if the study involves experimental drugs or devices, inform the subject that the research and the medical records may be reviewed by the Food and Drug Administration (FDA) and by the company sponsoring the research.
• avoid stating that drugs or devices have been approved for human use by the FDA if any part of the study is outside the licensed and approved indications of those items.  Patients interpret such a claim to mean that the FDA has licensed and approved this use of the item, not that the FDA has merely granted permission to investigate the use of the item.
• distinguish between consent to a study and consent to a treatment. In “treatment studies” (in which a patient who is undergoing a treatment is given a choice between undergoing that treatment as part of a study or undergoing it in a standard health care context), the study and the treatment involve different benefits, risks, and alternatives.

5.4 What Must Be Said About the Conduct of the Research?
Confidentiality vs. Anonymity
The researcher must describe the level of confidentiality or anonymity of the research data and the measures that will be taken to ensure that protection is maintained.  It is important to understand that confidentiality and anonymity are different forms of protection of research data.  Confidentiality means that a link exists between the subject’s name and the subject’s individual participation in the study.  Adequate explanation should be provided to the subject regarding the protection of this link, access to the information, and any limits to the protection. 

Anonymity allows a subject to participate without recording any identifiable information.  No one, including the investigator, will have the means to match an individual’s responses with their identity.

The phrase “only aggregate data will be presented” is appropriate only when it is true.  This phrase implies that the researcher will not describe individual subjects or the subject as an individual, even if the subject has a unique event. What is more common, however, and what the subject should be told, is that the subject’s identity will not be disclosed.

Conflict of Interest
Stevens’ CPHS requires that researchers inform their subjects of any conflicts of interest in the research.  For example, researchers should disclose any personal stake in companies that might be affected by the research might affect.

Finder’s Fees
Companies sometimes offer researchers incentives for recruiting subjects or conducting research on an investigational drug or device manufactured by the company.  The incentive may be either a monetary fee or a donation of equipment or materials.  Researchers must report these incentives to the CPHS, which may require that this information be disclosed to prospective subjects.

Payments to Research Subjects
If researchers plan to compensate subjects for participating in a study, the consent form must describe the terms of payment and the conditions under which subjects would receive partial compensation or no compensation (for example, if they withdraw from the study before their participation is completed). See section 3.14 Payment to Subjects

5.5 Assessing the Subject’s Understanding
The responsibility of ensuring that potential participant genuinely understands the research, including the risks and benefits involved, falls upon the researcher, not upon the prospective subject.  Hence it is critical to the consent process that the researcher not only field questions, but also asks questions.

Asking questions can further the discussion, elicit questions from the prospective subject, prompt the prospective subject to think more carefully about the project, and help the researcher decide whether the person has adequately understood the project. These questions must be prepared in advance and should be part of the information provided in the application.

Useful questions are open-ended and non-directive.  Such questions do not imply a correct answer and invite greater discussion than a simple “yes” or “no.”  Open-ended questions often begin with “what,” “where,” “how often,” “when,” and “please describe.”  Examples of open-ended questions are:

• “So that I can be sure you understand what is expected of you here, would you please explain to me what you think we’re going to ask you to do?”
• “Describe the purpose of the study in your own words.”
• “What more would you like to know?”

In contrast, examples of closed-ended and far less useful questions are:

• “Do you understand?”
• “Do you have any questions?”

Closed-ended questions tend to stop discussion and therefore should be avoided.

5.6 Documenting the Subject’s Consent with a Consent Form
Once a subject understands a study and expresses a willingness to participate, researchers must document the subject’s consent with a consent form.  A signature certifies the subject’s willingness to participate, though a signed form is not equivalent to assuring that the subject has understood the research.  Including a date with the signature avoids confusion about whether the subject began to participate before giving consent.

A researcher may need to prepare several consent forms, depending on who the subjects are likely to be.  For example, a single project may require a consent form for the guardian or parent of a child, a consent form for a competent adult subject, a simplified assent form for the 8- to 17- year-old or for the adult who is not competent to give consent alone, and a script for obtaining assent from children younger than 8.  [See following sections for discussion of assent forms.] Foreign-language versions of the consent forms are necessary for enrollment of people who do not speak and/or comprehend English. [See section 4.11 for discussion of translated consent forms. This section also discusses unexpected enrollment of non-English speaking subjects.]

The person who prepares the documents should:

• Print all documents in font no smaller than 12 points to make sure they are readable.  If the subjects will have difficulty with 12-point font, a larger font is necessary.
• Place the title of the study on the first page, exactly as it appears in the CPHS files absent a compelling reason to shorten or change the title. “Informed Consent” is not an acceptable title because it obscures the fact that informed consent is a process, not the document itself, and implies a completeness that the form may not have.
• Number each page after the title page so that pages appear in a logical order and to insure that missing pages will be readily noted (example: “page 2 of 4”).
• Include a consent form version date. This date should be updated each time a new version of the consent form is approved by the CPHS.

Format and Specific Requirements
The consent form must:

• Identify the researcher(s) by name along with their University and departmental affiliation on the first page of the consent form - If the project is conducted by faculty or staff, the first page of the consent form should be printed on departmental letterhead.  For student projects, the words “Stevens Institute of Technology” should appear in the header on the first page, and the faculty sponsor’s name and phone number should be given with the student’s name and contact information.
• Invite participation - Consent forms should “invite” participation. They should not say that a friend or a school’sprincipal recommends participation, nor should they “offer the opportunity” to participate.
• Summarize cautiously - Information described earlier in the consent form should be summarized only in order to clarify.  Summaries that suggest a warning or limitation of liability or opportunity for redress are not acceptable. Examples that are unacceptable are:
• “You understand that ...”
•  “The possible risks associated with this study have been presented.”
• “The method and purpose of administration of this study have been explained to you.”
• “You have been made aware of certain risks and consequences.”
• Include CPHS Review Statement – all informed consent documents (including unsigned cover letters, oral summaries and Assent documents should always include the following CPHS Review Statement:

               
ANY QUESTIONS REGARDING MY RIGHTS AS A RESEARCH SUBJECT MAY BE ADDRESSED TO   THE COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS AT STEVENS INSTITUTE OF TECHNOLOGY (201-216-5280).  ALL RESEARCH PROJECTS THAT ARE CARRIED OUT BY   INVESTIGATORS AT STEVENS ARE GOVERNED BY REQUIREMENTS OF THE UNIVERSITY AND     THE FEDERAL GOVERNMENT.

Readability and Technical Language
In writing consent forms, researchers must:

• Use the recommended format (see Sample Consent Forms)
• Use declarative sentences suited for an eighth-grade reading level.
• Write in the second person (“you”) rather than the first person (“I”), and avoid shifting from one to the other.
• Avoid strike-out formats (such as “You/Your spouse/Your child”), since they depersonalize the form and often make it difficult to read.
• Keep the description of the study as brief as possible, even if the study is complex. The details can be placed in an appendix.
• Use paragraph headings and illustrations. Use flow charts or calendar-like tables to explain studies that involve multiple visits, that ask subjects to go from one place to another, or that involve different protocols depending on research benchmarks.
• Describe quantities in lay terms (teaspoons, for example). Communicate size with an illustration or a reference common household object of the same size.
• Ask someone who is unfamiliar with the field to read the final draft of a consent form.  Software packages that evaluate a text’s “readability” may be helpful.
• Replace technical language with lay terms.

5.7 When to Submit the Form to the CPHS
Researchers must submit consent forms when they first apply for CPHS review and approval, and when they apply for continuing review.  Since the standards for consent forms change over time, in part due to changes in regulatory mandates and community styles and expectations, the CPHS reviews the form at renewal to ensure that it is up to date.

In addition, the CPHS may ask researchers to modify consent forms at other times, when circumstances warrant.  Any revisions made to a previously approved consent form must be submitted to the CPHS for approval before use.

5.8 When the Consent Requirement can be Waived
On rare occasions, the federal regulations for human subjects’ research allow a waiver of the requirement for informed consent. For example, a waiver is possible if a study investigates certain aspects of public benefit or service programs (see 45 CFR 46.116[c]).  Also, either a waiver or a consent process that omits or modifies the essential elements of informed consent is possible if the CPHS finds that:

• the research involves no greater than minimal risk to the subjects;
• the waiver or alteration will not adversely affect the rights and welfare of the subjects;
• the research would be impracticable without the waiver or alteration; AND
• the subjects will be informed of the study when it is over (if at all possible).

Only the CPHS can waive or modify the consent process.  Researchers are not authorized to make this decision.

5.9 Confidentiality
The use of confidential information is an essential element in many research studies, especially in the social and behavioral sciences.  The CPHS reviews research applications with regard to the necessity of obtaining private and confidential information and the safeguards used to protect breaches of confidentiality that could lead to a loss of privacy and potential harm to participants.  Potential harms include the risks of criminal or civil liability or damage to financial standing, employability, insurability, or reputation, stigmatization, and damage to social or family relationships.

The more sensitive the data collected about participants, the greater the protections of confidentiality the CPHS will require.  Protections and safeguards may include the use of identifying numbers for participants, the storage of data in a secure location (e.g., locked office or file cabinet, with limited access), and computerized security systems (e.g., password protected or encrypted).  Investigators should be aware and take appropriate precautions against unauthorized access to computerized data.  Violations of confidentiality can occur even when university researchers only have access to participant identification numbers and not their names.  For example, if investigators receive data containing identification numbers from another source, which can link the numbers with names, a breach of security at that source can compromise the confidentiality of participants.

Whenever possible, surveys and questionnaires should be anonymous, with no information about participants’ names and identifying information recorded.

Although the CPHS generally requires investigators to protect the confidentiality of participants, it may waive this requirement when participants explicitly and with knowledge of possible consequences agree to have their names, pictures or other identifying information disclosed in publications or presentations or serve as co-authors of reports or published materials.

5.10 Certificates of Confidentiality
The Public Health Service Act provides protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research.  Protection is given in the form of a Certificate of Confidentiality issued upon application for a particular project (note: federal funding is not a prerequisite).

A “Certificate of Confidentiality” protects subjects’ anonymity by protecting research records from compelled disclosure. Protection is available only to “research” (defined as a systematic investigation designed to develop or contribute to generalizable knowledge) under two conditions: (1) the research is on sensitive topics and (2) the additional protection is necessary to achieve the research objectives.

Research would be considered sensitive if it involves the collection of:

• information about sexual attitudes, preferences, or practices;
• information about the use of alcohol, drugs or other addictive products;
• information about illegal conduct;
• information that, if released could be damaging to an individual’s financial standing, employability, or reputation within the community;
• information in a person’s medical record that could lead to social stigmatization or discrimination
•  information about an individual’s psychological well being or mental health; or genetic information.

A Certificate of Confidentiality does not prohibit voluntary disclosure of identifying information about research subjects. Researchers, therefore, may voluntarily disclose matters such as child abuse or a subject’s threatened harm to self or others.  However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate the circumstances of disclosure.

In some instances, the CPHS may require an investigator to obtain a Certificate of Confidentiality.  Additional information is available through the National Institutes of Health web site.

5.11 Children and Adolescents
Written parent (or legal guardian) permission is required for studies involving children under the age of 18. If the research involves greater than minimal risk, signatures from both parents are required unless the second signature is not reasonably available.  A single signature is sufficient if only one parent has legal responsibility for the care and custody of the child or if one parent is deceased, unknown, or incompetent.  Parental permission is documented in a form similar to a consent form for an adult subject, but tailored to invite “your child” to participate rather than “you.”

The CPHS can grant a “waiver of parental consent,” but does so only on rare occasions and only if (1) the research will yield great benefit to the population being studied and (2) the procurement of parental consent would pose a considerable risk to potential subjects.

Once parental permission has been obtained, the agreement of the child is required.  Parental permission may overrule a child’s decision not to participate in therapeutic settings.  The child’s agreement is documented with an “assent form,” a child-friendly document that outlines the essential information about the research.  All children between 8 and 17 years old should receive an opportunity to assent; most children 8 years old or older have the cognitive and emotional maturity to understand a research project and to decide whether they want to participate in it.

Some children under the age of 8 may also be capable of granting and withholding assent, and the CPHS’ ask researchers to be sensitive to the needs of these children on an individual basis.  Researchers should draft a form (or a verbal script) that is age-appropriate and study-specific, considers the typical child’s experience and level of understanding, and treats the child respectfully while conveying the essential information about the study.  The form (or script) should:

• state why the study is being conducted;
• describe what will happen and for how long or how often;
• state that the decision to participate belongs to the child, and that refusal or withdrawal is “okay;”
• explain if participation will hurt and, if so, for how long and how often;
• describe the child’s other choices, if any;
• describe any good things that might happen;
• mention any compensation for participating; and
• ask for questions.

The document should be no longer than one page if possible.  Illustrations can be helpful, and larger type is easier for young children to read.  Studies involving children who are unable to read should provide appropriate procedures for a verbal assent process.  Studies involving older children or adolescents should include more information and may use more complex language.

Subpart D of 45 CFR 46.401-409, “Additional Protections for Children Involved as Subjects in Research,” specifies the conditions of participation for minor subjects

5.12 Consent and Language Barriers
When planning research that will include non-English speaking subjects, researchers should prepare consent forms in English and in the other relevant language(s).  The CPHS may consult with language experts or require a “back-translation” into English.

As an alternative to translated consent forms, the CPHS may approve a process consisting of an oral presentation of informed consent information in conjunction with a short form document stating that the elements of consent have been presented orally and a written summary of what is presented orally.  A witness to the oral presentation is required, and the subject must receive copies of the short form document and the summary.

When this procedures is used with subjects who do not speak English:

• the oral presentation and the short form written document (see sample attached) must be in a language understandable to the subject;
• the CPHS-approved English language informed consent document may serve as the summary; and
• the witness should be fluent in both English and the language of the subject.

At the time of consent, the following signatures should be obtained:

• the short form should be signed by the subject (or by the subject’s legally authorized representative);
• the summary (i.e., the English language informed consent document) should be signed by the person authorized under the protocol to obtain consent; and
• the short form and the summary should be signed by the witness.  When a translator assists the person responsible for obtaining consent, the translator may serve as the witness.

All foreign language versions of the short form document are a condition of CPHS approval (see 46.117(b)(2)).  Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened CPHS.

If a subject understands English but does not read or write English, an impartial witness should document that the subject understands the study and the consent process and consents to participate.

5.13 Cross-Cultural Consent Issues
The requirements for documenting informed consent vary among cultures.  The CPHS does not exempt from the consent requirement projects conducted in foreign countries or with other cultural groups here, but can waive the requirement for written documentation of consent.  In some settings, the process of signing the form is very intimidating and is thought to be riskier that the research itself.

Researchers planning to conduct cross-cultural research must justify the proposed method of documenting consent. The justification must include a description of any customs that constrain the typical informed consent process.

Subjects in foreign sites should receive referrals to local contacts for answers to any questions they may have about the research or about their rights.

Federal regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] require the CPHS to ensure that investigators promptly report “any unanticipated problems involving risk to subjects or others.”  The CPHS defines unanticipated problems involving risk to subjects as any problem or event which in the opinion of the investigator was unanticipated, serious AND at least possibly related to the research procedures.

These should be reported to the CPHS as soon as possible but no later than 10 working days using the required reporting form.

6.1 What to Report
The following events meet the CPHS’s definition of unanticipated problems involving risk to subjects or others and should be reported within the 10 day time frame:

• Any serious event (including on-site and off-site adverse events, injuries, side effects, deaths or other problems) which in the opinion of the investigator was unanticipated, involving risk to subjects or others, and was possibly related to the research procedures.
• Any serious accidental or unintentional change to the CPHS-approved protocol that involves risk or has the potential to recur.
• Any deviation from the protocol taken without prior CPHS review to eliminate apparent immediate hazard to a research subject.
• Any publication in the literature, safety monitoring report (including Data and Safety Monitoring Reports), interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research.
• Any breach in confidentiality that may involve risk to the subject or others.
• Any complaint of a subject that indicates an unanticipated risk or that cannot be resolved by the research staff.
• Any other serious and possibly related event which in the opinion of the investigator constitutes an unanticipated risk.
• Any event that requires prompt reporting according to the protocol or the sponsor.
• Incarceration of a participant.

Note that issues such as whether the event was on-site or off-site or whether the event involved a death is no longer of primary relevance in determining what should be reported.  If the event meets all 3 criteria of the CPHS’s definition of an unanticipated event (shown below), it should be reported using the reporting form as soon as possible but no later than 10 working days.

6.2 Definitions

• Unanticipated (unexpected) problems/events are those that are not already described as potential risks in the consent form, not listed in the CPHS application or not part of an underlying disease.  
• Anticipated (expected) problems/events do NOT meet the CPHS’s definition of an unanticipated problem involving risk to subjects or others.
• Serious problems/events are those which in the opinion of the investigator involve risk to subjects or others. Examples may include death, hospitalization, disability as well as breach of confidentiality.
• Non-serious problems/events do NOT meet the CPHS’s definition of an unanticipated problem involving risk to subjects or others.

Problems/events that are unanticipated or unexpected and serious should be reported to the CPHS as soon as possible but no later than within 10 working days only if in the opinion of the investigator they are possibly, probably or definitely related to the research procedures.  Those serious, unanticipated problems/events that the investigator deems unlikely or not related do NOT meet the CPHS’s definition of an unanticipated problem involving risk to subjects or others.  Follow-up reports on previous events should be reported as an unanticipated problem involving risk to subjects or others if the initial event itself met the CPHS’s definition of an unanticipated problem AND in the investigator’s judgment; this follow-up report adds value to the initial report.

NOTE: Reports of off-site events on studies that are closed at this site should be reported as unanticipated problems if the event meets the CPHS’s definition of an unanticipated problem/event AND in the investigator’s opinion, this event may affect the risk to subjects who have completed the study.

6.3 CPHS Review of Unanticipated Problems
The CPHS staff will forward the report to a designated committee member who shall evaluate the report and determine one of the following outcomes:

• no further action is required,
• the PI is to submit further information (to be specified by the reviewer),
• revisions to the informed consent are necessary – requested revision will be specified and may involve re-consenting of participants already enrolled,
• revisions to the protocol are necessary – requested revision will be specified,
• suspension of the protocol upon notification to and agreement of the chairperson, or
• termination of the protocol by the CPHS.

Depending on the severity of the event, the reviewer may ask that the report be presented at the next full committee meeting for discussion and further decision. If referred, the CPHS may require the PI to notify subjects of unanticipated problems.  This may be required to be in the form of a letter sent to all subjects and/or as part of a revised consent form to be signed by returning participants.  The CPHS may require more active monitoring of a research study, depending on the perceived risk to the research.

All correspondence and decisions will be communicated/documented via email and may in addition be transmitted verbally.

Non-compliance is defined as conducting research involving human subjects in a manner that disregards or violates federal regulations governing such research.  This can include, but is not limited to, failure to obtain CPHS approval for research involving human subjects, inadequate or non-existent procedures for informed consent, inadequate supervision in research involving experimental drugs, devices or procedures, failure to follow recommendations made by the CPHS to insure the safety of subjects, failure to report unanticipated problems or proposed protocol changes to the CPHS, and failure to provide ongoing progress reports.

7.1 Allegations of Non-compliance
45 CFR 46.113 states:
“An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects.  Any suspension or termination of approval shall include a statement of the reasons for the IRB’s actions and shall  be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.”

To exercise this statutory authority, the IRB shall review all allegations of non-compliance with human subjects’ regulations and review any study that has been associated with unexpected serious harm to research subjects.  The IRB will follow these policies and procedures for conducting an inquiry and investigation into allegations of non-compliance and in reviewing incidents of unexpected serious harm to subjects.

CPHS will take appropriate action to insure the safety and welfare of human research subjects.  These actions may range from corrective or educational measures for the researcher to terminating CPHS approval for all active studies of a research.  Further, the CPHS may suspend approval of research projects at any time during an inquiry or investigation to assure the protection of human subjects.

This policy includes written procedures for reporting actions to appropriate University and federal government officials as required by federal regulations.

These policies and procedures apply to all research activities of faculty, staff, students and others who are involved in research that falls under the jurisdiction of the CPHS.

7.2 Reporting Allegations of Non-compliance
The CPHS Coordinator has primary responsibility for receiving allegations (anonymous or otherwise) or evidence of non-compliance involving human research participants, particularly possible serious or continuing non-compliance.

Allegations may also be reported to:

• the principal investigator;
• the Provost;
• the Executive Director of Sponsored Programs;
• the Director of Research Data, Audit and Compliance, or;
• any CPHS staff member.

The CPHS itself may initiate a allegation based on information available to the CPHS (e.g., deficiencies noted in CPHS files, media or scholarly reports of research activity subject to CPHS jurisdiction).

7.3 Review of Allegations of Non-compliance
Purpose
In the inquiry stage, factual information is gathered and expeditiously reviewed to determine if an investigation of the complaint is warranted.  An inquiry is not a formal hearing or an in-depth analysis of the allegations; it is designed to separate allegations deserving further investigation from those that are frivolous, unjustified or related to minor infractions.

Process
Whenever an allegation or complaint of non-compliance is made, the Director of Research Data, Audit and Compliance will, after consultation with the Executive Director of Sponsored Programs, forward the allegation to the Provost who will appoint an inquiry panel.  Written notice of the allegations will also be sent to the researcher and a response will be requested within 10 working days.  If the complaint raises issues of safety and welfare for research subjects that are apparent upon initial review, the researcher will also be given notice of an opportunity to address in his/her response the possible summary suspension of the researcher’s project(s).

The inquiry panel will review the allegation of non-compliance, the response from the principal investigator and any other information necessary to determine whether an investigation is warranted.  The inquiry panel may interview the researcher and others, but is not obligated to do so.  It may be necessary to secure critical data or materials at the outset of an inquiry to protect the integrity of those data or materials or records. The CPHS maintains the authority to secure such materials at any time during an inquiry or investigation.

Recommendations and Outcomes
At the conclusion of the inquiry phase, the inquiry panel will make a recommendation to the Provost.  Possible recommendations include:

• dismissal of the allegation or complaint as unjustified;
• referral of the matter to another more appropriate system within the University for resolution (e.g., Grievance, Academic Misconduct; Student Conduct Code);
• resolution through corrective or educational measures where the violation of human subjects regulations is minor or inadvertent; and
• a formal CPHS investigation where the allegation or complaint appears founded and is of a serious nature.

The Provost will promptly act upon the recommendation of the inquiry panel and notify the researcher in writing of the outcome of the inquiry phase.  This notice will include a statement of the reasons for the decision. Depending on the nature of the allegations and the extent of the review required, the inquiry phase is expected to be completed within thirty working days.  The Provost may grant an extension of this time frame if warranted.

7.4 Investigation of Allegations of Non-compliance
Purpose
The purpose of the investigation is to explore the allegations by assembling and examining relevant information.  The investigation panel’s charge is to generate a report that summarizes the information it considered, its conclusions as to whether there was non-compliance with human subjects’ regulations and recommendations for action. During an investigation, additional information may emerge that justifies broadening the scope of the investigation beyond the initial allegations.  The researcher shall be informed if new and different allegations are discovered during the course of the investigation.

Process
The investigation will be conducted by an ad hoc panel of at least three CPHS members established by the Provost.  One of the panelists shall be a member of the inquiry panel.  All other members will be CPHS members whose areas of expertise are suited to reviewing the complaint and area of study.  Depending on the nature and scope of the complaint, CPHS members may be relieved of their regular CPHS duties during the investigation so as not to be overburdened.

The investigation panel may use any and all materials and reports gathered during the inquiry phase but is not limited by actions or conclusions of the inquiry panel.  The investigation panel may obtain documents and other records relevant to the investigation, such as researcher records, medical charts, grant applications and other scientific or scholarly data. The investigation panel may interview any persons who may have information relevant to the complaint. All interviews will be tape recorded.  The panel may draw on the resources of the institution or external consultant to assist in the review of issues which require expertise beyond or in addition to that available on the investigation panel.

The researcher under investigation will be given an opportunity to submit written comments and appear before the panel on at least one occasion prior to the panel issuing its report.  The researcher may offer relevant information to the panel and suggest other individuals to be interviewed.  The researcher also may be accompanied by an advisor, including an attorney, at any time the researcher appears before the panel.  The researcher shall give the panel notice of the advisor’s participation at least 48 hours prior to any interview.

At the conclusion of its investigation, the investigation panel will prepare a report summarizing the information it considered and outlining its conclusions and recommended actions.  The investigation panel will forward a copy of this preliminary report to the researcher and give the researcher ten working days in which to submit comments to the report.  The investigation panel will review any comments received from the researcher and decide, based on these comments, whether to modify its preliminary report. When finalized, the investigation panel will send the Provost its report with any comments received from the researcher.  Depending on the case, the investigation phase is expected to be completed within 60 working days. The Provost may grant extensions if warranted and may request interim reports.

Outcome
The Provost will base his/her decision on the report of the investigation panel and any comments submitted by the researchers.  Actions the Provost may take with respect to the investigation include, but are not limited to: 1) dismissal of the complaint as unjustified; 2) remediation or educational measures; 3) increased reporting by the researcher of his/her human subjects research activities; 4) restrictions on research practice, such as limiting the privilege to minimal risk or supervised projects; 5) suspension of approval for one or more the researcher’s studies; 6) termination of approval for one or more of the researcher’s studies; 7) withdrawal or retraction of publications/presentations; and 8) referral to other University officials or committees for possible further review and action by those bodies.

7.5 Suspension and Reporting
At any time during the inquiry or investigation process, the CPHS may determine that it is necessary to suspend the accrual of research subjects or suspend approval of research project(s) to assure the protection of human subjects.  The authority to suspend research rests with the CPHS; both the inquiry and investigation panels may recommend suspension to the CPHS.  If suspension is warranted, it normally will occur at the end of the inquiry phase.  Except in cases of imminent harm to research subjects, the CPHS will not suspend approval of research studies until the researcher has had an opportunity to respond to the initial allegation of non-compliance.

When the CPHS makes a decision to suspend approval of research, it will notify the Provost and other appropriate University officials.  These may include the researcher’s department head, dean of the college, and senior administrative officers.  The Provost, who serves as the authorized institutional official, will send written notice on behalf of the CPHS to the following entities, as required under federal regulations:

• the Federal Office for Human Research Protections (OHRP);
• the Federal Food and Drug Administration (FDA) if the suspension of research approval involves an investigation drug or device;
• the OHRP and FDA as applicable, if the matter involves the non-submission of a project which should have been reviewed by the CPHS, and the researcher’s failure to do so has resulted in unanticipated risks to human subjects or serious or continuing non-compliance with CPHS requirements; and
• external and internal sponsors funding a study under suspension.  Reports will be filed within five working days of suspension.

In some cases reporting to professional licensing boards or state agencies may also be required.  These reports will be made by the Vice President for Research or other appropriate University officials.

7.6 Appeals/Reconsideration
Purpose
The purpose of an appeal is to give the researcher an opportunity to request reconsideration of the Provost decisions under certain limited circumstances.  Grounds for appeal are limited to: 1) new information not reasonably available during the investigation; 2) material failure to follow these policies and procedures; and 3) sanction exceeds the severity of the violation.  No other grounds will be considered.

Process
The appeals panel will be comprised of three CPHS members who have not served on any other panel involved in the process (i.e., inquiry or investigation panels).  The appeals panel will review the written statement of appeal by the researcher and make a recommendation as to whether the Provost should reconsider any aspect of his/her decision based on the ground outlined above.  In reaching this recommendation, the appeals panel may seek a response from the investigation panel.  The decision whether to forward a request for reconsideration should be made within 10 working days.

If the appeals panel denies the appeal, the Provost’s prior decision becomes final.  If the appeals panel recommends reconsideration, the Provost re-opens the case.  When the Provost reopens the case, he/she may choose to reconvene the investigation panel or reconsider the matter on his/her own.  The Provost (or the investigation panel, if reconvened) will offer the researcher the opportunity to appear personally to present the appeal.

Upon reconsideration, the Provost determines whether to modify or uphold his/her original decision.  This action is final. The reconsideration phase is expected to be completed within 30 working days.

7.7 Dissemination of Findings
At the stage when the Provost’s decision becomes final (i.e., 5 working days after his original decision if there is not appeal; upon a decision by the appeals panel to deny the appeal; or upon the Provost’s final determination if the case is forwarded for reconsideration), the findings will be released to the researcher and to appropriate University and governmental officials as required under federal regulations.  The same guidelines as set forth above for reporting suspensions will apply.  Further, it may be necessary to inform these same officials of the status of the proceedings while they are pending.

Coordination with other Investigative Processes
Some complicated cases require review by other institutional or external entities.  The CPHS will cooperate in the review of allegations of academic misconduct, financial mismanagement, FDA inspections, etc. In cases that appear to involve academic misconduct, the investigation panel may report allegations of such misconduct to appropriate institutional officials.  Where academic misconduct and CPHS investigations are pending against the same researcher, the CPHS will participate in a close coordination of processes to avoid duplication of effort and minimize competing use of resources.

Conflict of Interest/Commitment
As with all CPHS processes, any CPHS committee member who has a conflict of interest or commitment relating to the matter under review will excuse himself/herself from the proceedings and an alternate will be designated by the chair.  It is permissible to allow substitution of non-CPHS members for conflict of interest/commitment concerns at any stage in the establishment of an inquiry or investigative review panels.

Confidentiality for Complainants and Witnesses
Generally, the researcher under review should have access to the identity of complainant(s) and others who provide information.  However, if such individuals are in a status subordinate to the researcher and wish to maintain their anonymity, the CPHS will make every effort to protect their identities while at the same time affording the researcher access to the substance of the allegations and information presented against him/her.  The CPHS cannot guarantee absolute anonymity.

Retaliation

Institutional Review Board review is an ongoing process – not a one-time step.  Regular reevaluation ensures that research is conducted responsibly.  Even in responsibly conducted studies, a one-time review in inadequate, since risks can become apparent only after research has begun, and since the regulations for human subjects’ research are constantly being refined as the risks and benefits are better understood.  Unexpected developments in a project can raise questions about the conduct of the research, and new findings can raise questions about the project.

8.1 The Process of Continuing Review
“Continuing review” refers to regularly scheduled complete reappraisals of a project.  The goals of continuing review are to ensure that the risk/benefit ratio is still acceptable, that the measures taken to safeguard subjects are adequate, that the approved protocol is followed, and that the project reflects any changes that have been made in the regulations for human subjects’ research since the last approval.

The CPHS may require changes in protocol or revisions in the consent form if the study’s risks were originally underestimated, but the opposite can also occur: the investigators and the CPHS may have underestimated the benefit to research subjects.

8.2 When Continuing Review is Required
The Department of Health and Human Services (DHHS) regulations 45 CFR 46.109(e), require that “an IRB shall conduct continuing review covered by this policy at intervals appropriate to the degree of risk, but not less than once per year...”  This continuing review must be substantive and meaningful.  Research for exempt status applications will be reviewed every 5 years due to the reduced risk to human subjects.  The CPHS will determine a review interval for the research as appropriate to the degree of risk, but not greater than one year from the last date of CPHS approval.  The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of CPHS approval. Therefore, continuing review and re-approval of the research must occur on or before the date when CPHS approval expires.  If the research involves the following, the CPHS will review more often than annually:

• Previous suspensions of the researcher due to compliance, record-keeping or other concerns; and/or
• Any other situations for which the CPHS deems more frequent review appropriate.
• Research that involves adults unable to consent and the study is deemed greater than minimal risk.
• Research that includes children and is approved under 45 CFR 46.406(Subpart D).

The aforementioned research activities may also be used to determine if verification from sources other than the investigator is necessary to verify that no material changes have occurred since previous CPHS review.

A notice for renewal and a “continuing review form” are sent to the principal investigator approximately 60 days before the review date.  The form should be completed and returned to the CPHS coordinator by the indicated deadline.  The notice for student projects is sent to the faculty sponsor who is responsible for notifying the student and ensuring timely submission of the renewal form.  The study expiration date is crucial for the continuation of the study.  If CPHS approval has expired, the PI must cease all research activities and may not enroll new subjects in the study after the indicated expiration of the CPHS approval.  All data collection must stop and no funds may be spent (if the research is funded).  However, if the IRB determines that an overriding safety concern and/or ethical issue is involved or that it is in the best interests of the individual subjects to continue participating in the research activities, the IRB may permit the subjects to continue in the study for the time required to complete the continuing review process. A new application and review will be required to reinstate the study if it expires.  If the investigator does not respond, the will classify the study as “inactive.”  If the study is complete, the investigator is asked to complete the “Final Report” section on the “Continuing Review Form.”

Lapses of approval as outlined in the continuing review process are not reportable to OHRP under their federal guidelines; however the investigator may not continue recruiting, analyzing or doing work of any kind on the lapsed project.  This could have profound affects if the project is externally sponsored.

8.3 What Forms to Complete
Continuing review requires that you complete the “Continuing Review Form” and attach a current consent form if subjects are currently being recruited.  The form requires the following information:

• the number of subjects enrolled since the last review and the total number of subjects enrolled to date;
• breakdowns of the subject population by gender and other demographics;
• a summary of the results of the research to date, including:
• any unanticipated risks or adverse outcomes, and
• any early indication that one of the treatments under study is significantly better or worse than others;
• any difficulties recruiting or retaining subjects, an explanation of the difficulties, and the number of subjects who withdrew from the study;
• changes in the last year that were approved and the dates they were approved;
• if currently recruiting subjects, a copy of the consent form currently in use (as most recently approved by the CPHS).

Incomplete forms will be returned, which may cause a delay in getting the study on the desired committee meeting agenda.

8.4 Level of Review
Generally, a project usually merits the same level of review for its’ annual, continuing review as it received originally.  Protocols that were originally categorized as requiring Full Committee review will require Full Committee review for the annual renewal.  As in the initial review, the CPHS may require revisions in the protocol or the consent documents.

The CPHS will determine a review interval for the research as appropriate to the degree of risk, but not greater than one year from the last date of CPHS approval.  The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of CPHS approval.  Therefore, continuing review and re-approval of the research must occur on or before the date when CPHS approval expires. If the research involves the following, the CPHS will review more often than annually:

• Previous suspensions of the research due to compliance, record-keeping or other concerns; and/or
• Any other situations for which the CPHS deems more frequent review appropriate.
• Research that involves adults unable to consent and the study is deemed greater than minimal risk.
• Research that includes children and is approved under 45 CFR 46.406(Subpart D).

The aforementioned research activities may also be subject to verification from sources other than the investigator that no material changes have occurred since previous CPHS review.

8.5 Making Changes in Research Protocols
A project approved by the CPHS must be executed according to the approved protocol.  Any changes in subject population, recruitment plans, research procedures, study instruments, study sites, or major research personnel require prior approval by the CPHS.  Changes enacted without prior approval constitute protocol violations.

Researchers who plan a change must complete the “Request for Revision Form.”  The title should be that of the previously approved study and a description of the proposed changes should be written in lay language. Explain why the change is needed, describe any implications for subjects, and provide the appropriate revised consent documents.  All requested changes should be highlighted in the submitted materials.

8.6 Absent and Exiting Principal Investigators
If a principal investigator on an approved project goes on sabbatical leave from the University, an interim PI must be appointed.  The CPHS should be informed of this person’s qualifications and the new PI should write to the CPHS accepting the responsibility for the treatment of subjects.  If a researcher leaves the University permanently, the CPHS should be notified of any interim investigators, or of the final replacement.  Otherwise, the study will be filed as “inactive.”

If an investigator is leaving the university and the study will not continue the investigator is asked to complete the “Final Report” section on the “Continuing Review Form.”

8.7 How Changes are Reviewed
All requests for revisions are reviewed by the Chair or his or her designee.  The Chair, or his/her designee, will provide approval if the changes are minor and do not alter the risks and benefits to the subjects, affect the equitable enrollment of subjects, or modify informed consent protections.  Examples of minor changes include the substitution of one esearch instrument for a comparable one or the replacement of a co-investigator with an investigator with equivalent qualifications.  If the requested modifications in research are not minor and represent a significant revision in the approved research or increase the risks to subjects, the Chair, or his/her designee will refer the request for revisions to the full CPHS for consideration at a convened meeting unless the amended research would qualify for expedited review. 

Investigators are notified in writing of CPHS decisions on revisions. If a request for revision is not approved, the CPHS will provide the reasons for its decisions.

8.8 Reportable/Unanticipated Events
Unanticipated Events at Stevens
Unanticipated events are unexpected problems of a nature, severity, and frequency not described in the information originally provided to the CPHS or to participants.  Examples include unexpected complications in a subject, missteps in the consent documentation, or breaches of confidentiality.  Unanticipated events should be reported to the CPHS by means of the “Reportable Event Form” as soon as identified but not longer than 10 working days from the time of the event/occurence.

A study may be suspended to ensure subjects’ safety.  Reports of events occurring at other sites receive expedited review, but in some cases the full CPHS is involved.  All events that occur at Stevens become agenda items and are reviewed at a full CPHS committee meeting.

Unanticipated Events at Other Institutions in a Multicenter Trial
If the project is a multicenter trial and the event occurred at another institution, the researcher must write to the CPHS, describing the nature of the event, its severity, the likelihood that it will occur at Stevens, and the implications for future subjects.

Death of a Research Subject
Researchers should alert the CPHS immediately to the death of any study subject, whether the death is believed to be related to the study or not.  A “Reportable Event Form” must be submitted as soon as possible.

New Risk/Benefit Findings
As a study progresses and the risks and benefits of participating in the study are better understood, researchers may find that the study must be stopped, for reasons of either risk or benefit.  For example, in some placebo-controlled trials, preliminary findings may give compelling evidence that a new treatment is efficacious.  It then becomes unethical to continue giving placebos. (This occurs most frequently in multicenter trials in which a central statistical center receives and processes large volumes of data from several sites.)

In such cases, the investigator should write to the CPHS, describe the findings and the need to suspend the placebo portion of the study.  If the CPHS agrees, the researcher should identify all subjects who received a placebo and invite those subjects to continue in an “open label” study in which all subjects receive the study medication.  If the trials are modified and continued, the consent documents should be revised to reflect the newly identified benefit.

However, if previously unanticipated risks are identified, the CPHS should be notified immediately via the “Reportable Event Form” and the protocol assessed to determine the project’s continued viability.  Unanticipated risks are not automatically a reason for the study’s termination.  That said, due consideration must be given to assess the ramifications of the previously unanticipated risk.  If the study continues, the consent document must be revised to reflect the new information

8.9 Recordkeeping
Researchers should maintain a file of all documents concerning the use of human subjects in research for not less than five years after conclusion of the study. The file should include copies of all documents and include original paperwork whenever appropriate.  The principal investigator’s records should mirror the CPHS’s records.

Researchers should have the following documents on file:

• a copy of the original application submitted to the CPHS, including the consent form and the research protocol;
• the original of the CPHS’s response;
• a copy of responses to CPHS contingencies or requests for additional information;
• the original notice of final approval;
• a copy of the “Certification of Approval” sent by the CPHS to any funding agencies;
• copies or originals of all other correspondence with the CPHS;
• copies of completed “Continuing Review” forms and attachments;
• the original notice of renewal of approval and certification, where applicable; and
• copies of any inspection or audit reports.

In order to provide confidentiality, original signed consent forms should be kept in a secure location separate from correspondence with the CPHS but readily available to inspectors.  CPHS records are subject to inspection by federal authorities.

Sanctions for incomplete or nonexistent records include suspension of funding, fines, exclusion from future funding, and suspension of laboratory access.

All investigators and research personnel listed on a human subjects’ application submitted to the Committee for the Protection of Human Subjects (CPHS) are required to complete a training course prior to protocol approval.
Why?
This requirement was first mandated by the National Institutes of Health in 2000 for individuals considered to be "key personnel" on research studies involving human subjects.  Stevens, in its approved Assurance with the federal government, has indicated that it applies the same standards and requirements to all human subjects’ research regardless of the source of support.  Because of this and our commitment to ethical research, the education requirement is extended to the following individuals:
Who?

• Principal Investigator(s) on all projects that include research involving human subjects
• All individuals responsible for the design or conduct human subjects research
• Those individuals identified as key personnel of consortium participants or alternate performance sites if they are participating in research that involves human subjects
• Those serving as voting and ex officio members of the CPHS

Investigators who conduct human subjects’ research that is exempt (as defined at 45 CFR 46.101(b)) from full CPHS review and approval must also comply with the education requirement; this became an NIH requirement in 2005 and Stevens feels it is an appropriate requirement regardless of the source, or presence, of funding. Exempt protocols must still be submitted to the CPHS Expedited Review Subcommittee for administrative review.  A list of exempt categories is available in the “Resource Material/Guidance” section

Failure to comply with the education component of our assurance is considered a circumstance of noncompliance, and has the potential to negatively affect funding opportunities for Stevens’ faculty, staff, and students.  It is the PI’s responsibility to ensure that all individuals engaged in research have been appropriately trained.
What?
Two options are available to fulfill this requirement:

1. (RECOMMENDED): The web-based Course in the Protection of Human Research Subjects through the Collaborative Institutional Training Initiative (CITI). CPHS recommends this option as its primary one because CPHS personnel are able to access individual transcripts and verify training, making this the most convenient option for the PI and all associated personnel.
2. The CPHS will also accept NIH Human Subject Research training certificates.

How?

1. CITI training: To begin the online course, visit the CITI website and select “Register for the Course”. Select Stevens Institute of Technology as your institution, and a username and password. There are four options for human subject research training based on your scientific disciplinary focus, the level of student or faculty member, and the focus of your research:

Group 1: Human Subject Research-Biomedical and Physical Science Research Investigators and Graduate Students

Group 2: Human Subject Research-Social and Behavioral Research Investigators and Graduate Students

Group 3: Human Subject Research-STEVENS IRB Members and Staff

Group 4: Human Subject Research- Students Conducting no More than Minimal Risk Research

2. NIH training: This course is online. CPHS personnel CANNOT access the transcripts for this course; a copy of the certificate must be submitted to the CPHS Coordinator prior to final approval.

When?
The CPHS reviews documentation for the education requirement prior to the initial approval of a CPHS application, and when a revision is requested to add additional personnel. A refresher course is required every three years.

The CITI program provides a shorter version of the original training, listed as "Refresher Course." This will meet the training requirements for research personnel who have completed the original training course.

Stevens extends this training requirement to all research, regardless of funding source. For more information contact the CPHS office at 201.216.5280 or visit http://grants.nih.gov/grants/policy/hs_educ_faq.htm.

References:
Stevens Federal Wide Assurance number is 00014433 (available to Stevens personnel upon request)
Stevens IRB Number is 00005952
Expiration date is 5.30.2017

Most federal and private funding agencies will not award a grant for a research project involving human subjects until the Institutional Review Board (IRB) has certified its approval.  However, the University’s processes allow for concurrent processing of the human subjects review and the management review of a proposal.

10.1 The OSP Routing Form
The Routing Form is used by the Office of Sponsored Programs (OSP) to obtain and document required management approvals and capture institutionally relevant data when an investigator is seeking external funding.  This form contains a number of assurances and certifications, one of which pertains to the involvement of human subjects.  The protocol should be submitted to the CPHS in time for a decision before the proposal due date or at the time of award consideration.

Ideally, all research proposals would be reviewed and approved by the CPHS before the proposal is submitted for external funding.  Investigators should affirm the approval on the Routing Form by specifying the date that the CPHS approval was given. (This is the date of the CPHS meeting – not the date of the letter.) Concurrent processing is more common however. The Routing Form, indicating that CPHS approval is pending and providing the date the project was submitted for review is acceptable.

10.2 Special Situations
Submission to the funding sponsor prior to CPHS approval (circumstance #1 – private or non-profit organization):
Occasionally, CPHS approval may still be pending when OSP receives the proposal for submission.  If the funding sponsor’s policy allows submission before CPHS approval, then OSP will submit the proposal. The investigator is then responsible for notifying the sponsor by submitting a copy of the CPHS approval letter when it is issued. Account will not be activated and funds may not be expended until all safety committee approvals are confirmed by OSP.
Submission to the funding sponsor prior to CPHS approval (circumstance #2 - NIH):
CPHS approval is often still pending when OSP receives the proposal for submission.  Recognizing that many more proposals are submitted than will ever be funded, NIH provides a specific mechanism to investigators that allows for some time accommodation.  Universities with proposals that are identified with a high likelihood of funding will be asked to submit documentation (IRB approval being one of those items) to NIH during the “Just-in-Time” interface between the agency and the university.  That said, the time allowed during a “Just-in-Time” solicitation of required documentation is usually short. Waiting to prepare and submit a human subjects’ application to the CPHS for review until word is received via a “Just-in-Time” request for required documentation may prove unwise.  Depending on the complexity of the methodology, subject pool composition and collection sites, it might not be the case that FULL approval is given at the initial review.  Data collection cannot begin before receiving FULL, unconditional approval.  Account will not be activated and funds may not be expended until all safety committee approvals are obtained.
Funding awarded prior to CPHS approval:
Though unusual, a funding sponsor might occasionally make a conditional award before CPHS has approved the research project.  When this occurs, the funding sponsor will usually specify a time limit (usually sixty days or less) for CPHS approval.  Again, the investigator is responsible for notifying the sponsor of CPHS approval. The investigator may not begin data collection prior to receiving FULL, unconditional approval.
Developmental proposals:
Proposals in the development or concept stage pose a dilemma for investigators, funding sponsors, and the CPHS. Funding agencies may be unwilling to consider a proposal without CPHS approval, yet given the early stage of the project, the investigator may not be able to provide a complete protocol or consent document. In these situations, the CPHS may grant a “contingent approval” that will satisfy the sponsor, yet allow for additional review to protect the subjects. The investigator should include an explanation for the deficiencies in the application as well as a statement that research will not begin until the complete project has CPHS approval.
Program project grants and training grants:
Program projects are large, multi-project studies designed to produce a coherent body of research from many subprojects. Training grants also may include a variety of subprojects. The initial application to the CPHS should include the title of the overall program project, the principal investigator’s name and contact information, and a list of the subprojects with the investigators’ names and contact information for each. All subprojects in the program grant must be submitted to the CPHS separately. It is the responsibility of the principal investigator for the overall project to ensure that the subproject investigators submit their applications in time to allow for review and approval.  The CPHS will certify its approval of the overall project only after it approves all subprojects.
Additional endorsements:
Funding sponsors occasionally require additional documents of special assurances.  If this situation arises, the investigator may contact the CPHS Coordinator for additional signatures or forms.

10.3 Changing the Title of a Research Project
Occasionally an investigator wants to change only the title of a research project to make it more competitive for a particular funding sponsor.  Any change in the protocol of a research project must be approved by the CPHS.
Changes in the title can be handled in two ways:

• If the original title will no longer be used, the principal investigator should prepare and submit the form entitled “Request for Revision.”   Information provided should include the original title and the latest CPHS approval date.  A revised consent form must be enclosed (since the consent form gives the project’s title).  If the change is approved, the most recent approval date for the original study will apply to the recently re-titled project.
• If the original title is to remain active but funding is sought from another agency for a different title, the investigator should prepare and submit the form entitled “Request for Revision” to request approval of an additional title. This request should certify that the study with the new title is identical to the study under the original title.  The request should include a revised consent form as well as a copy of the grant application associated with the new title.  This procedure may be used only when the research procedures are genuinely identical to those approved previously.  If the project does not receive funding and the investigator doesn’t intend to use the title for another submission, the CPHS should be advised that the title will be ‘retired.’

Researchers must file for these changes at least 30 days before the grant submission date.  In all cases investigators must provide a copy of the grant proposal.

10.4 Unfunded Proposals
If a proposal is not funded, the investigator should inform the CPHS whether or not the work will be conducted in the absence of external funding.

Assent – a child’s affirmative agreement to participate in research.  Mere failure to object should not, absent affirmative agreement, be construed as assent.

Behavioral/Social Science Research – The goal of social and behavioral human research is similar to clinical research – to establish a body of knowledge and to evaluate interventions – but the content and procedures often differ.  Social and behavioral research involving human research participants focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys, interviews, observations, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention.

Children – persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.  The legal age of consent in the State of New Jersey is 18.

Clinical Research – Clinical research involves human subjects: a) to increase scientific understanding about normal or abnormal physiology, disease states, or development of humans and b) to evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention for humans.

CPHS – Committee for the Protection of Human Subjects is the designated Institutional Review Board empowered by regulation and by expertise to review and approve all human subjects research performed at Stevens Institute of Technology.  The CPHS is established in accord with and for the purposes stated in 45 CFR 46.

DHHS - the Department of Health and Human Services

FDA – the Food and Drug Administration

Federalwide Assurance (FWA) – is a document that fulfills the requirements of 45 CFR 46 and is approved by the Office for Human Subjects Protections.  Stevens has an approved FWA on file with OHRP. The FWA number is 00014433.

Human Subject – is a living individual about whom the investigator conducting research obtains (a) data through intervention or interaction with the individual or (b) identifiable private information.  Intervention includes both physical procedures, by which data are gathered (for example, venipuncture), and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.  Private Information includes information about behavior that occurs in a context, in which an individual can reasonable expect that no observation or recording is taking place, and information, which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record).  Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information), in order for obtaining the information to constitute research involving human subjects.

Informed Consent/Authorization – the knowing agreement/authorization of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint of coercion.  Information conveyed in the consent document must include all essential elements listed in Section 5 of this Handbook.

IRB – Institutional Review Board is the administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated. The Institutional Review Board has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.

Legally Authorized Representative – an individual or judicial or other body authorized under applicable law to consent/authorize on behalf of a prospective subject to that subject’s participation in the particular activity or procedure.

Minimal Risk – the risks of harm anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [NOTE: The definition for minimal risk for incarcerated persons is different.  It is defined as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.]

OHRP –Office for Human Research Protections.  This is an office in the Office of the Secretary of
Health and Human Services responsible for regulatory oversight of human subjects’ research

Research – a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.  Research is defined as both the Common Rule (45 CFR 46) of the Federal regulations and by the Privacy rule of HIPPA.

SHARP – Stevens Handbook of Research Processes

• No claims should be made, either explicitly or implicitly, that the drug or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. No claims should be made that participation in the research will result in an improvement of the focus area/item being studied.
  Such representation would not only be misleading to subjects but would also be a violation of the FDA’s regulations concerning the promotion of investigational drugs [21 CFR 312.7(a)] and of investigational devices [21 CFR 812.7(d)].
• Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational. A phrase such as "receive new treatments" might lead study subjects to believe they will be receiving newly improved products of proven worth.
• Advertisements should not promise something like "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.
• Generally, advertisements to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest.
  • The name, phone number and address of the investigator and/or research facility;
  • The condition under study and/or the purpose of the research;
  • In summary form, the criteria that will be used to determine eligibility for the study;
  • A brief list of participation benefits, if any (e.g., a no-cost health examination);
  • The time or other commitment required of the subjects; and
  • The location of the research and the person or office to contact for further information
  • CPHS Review Statement

Summary:

Preamble:

1. ATTENDANCE AT REGULAR IRB MEETINGS
   Normally regular Committee meetings are closed to the public, although exceptions may be made by the Committee Chairperson. The IRB is encouraged to hold special public sessions on issues of unusual interest to the broader University community in those cases where a significant number of individuals have asked to meet with the IRB or where concerns have been raised about matters related to IRB business.
2. MINUTES OF COMMITTEE MEETINGS
   In order to encourage open and frank discussion at IRB meetings, and to have detailed records of Committee proceedings (including confidential issues and matters under investigation), minutes of normally are not made available to others outside the University administration unless otherwise required by law or external regulations.
3. ANNUAL REPORTS OF COMMITTEE ACTIVITIES
   The IRB Chair shall prepare an annual report to the Provost, summarizing the nature and volume of the Committee’s activities. Confidential matters should not be included in such reports, but should be conveyed separately to the Provost.
4. PROTOCOLS AND HUMAN CONSENT FORMS
   The IRB shall consider a research protocol, and, if applicable, the form used by the investigator to obtain the consent of human subjects, to be confidential documents.
   
   Written requests to release a protocol or a consent form should be directed to the Principal Investigator, with a copy to OSP Research Data, Audit and Compliance. Such requests must state the reason for the release of the protocol or consent form. Investigators are encouraged to grant such requests whenever possible; if a request is not granted the investigator must disclose to the requester a summary statement explaining the purpose and nature of the study. (A disclosure will not be made until the proposal for the study is funded by an external sponsor, or, in the case of a study not externally funded, until the study is initiated.)
   
   Requests for consent forms or protocol documents associated with groups of research projects, such as those associated with particular investigators or funding agencies, will be denied.
   
   Decisions to deny the release of a protocol or consent form may be appealed to the Provost, who is responsible for adjudicating disputes.
5. IMPLEMENTATION
   Questions about interpretation or implementation of these Guidelines should be referred to the Provost, who is also responsible for adjudicating disputes related to any of the provisions of the Guidelines.

STATEMENT

IRB member must disclose a conflicting interest to the IRB Chair or CPHS Coordinator that involves any protocol under review, and must leave the room during the discussion of and voting on a project, except if the IRB member is providing information at the IRB’s request. DEFINITION OF CONFLICTING INTEREST A conflicting interest of an IRB member (or consultant) generally includes the following. The aggregate interest of the member (or consultant) and his/her immediate family is considered.

• Participation in a project (IRB member is listed as an investigator on the project or is a member of the research team);
• Supervision of a project (IRB member is an academic sponsor of the Protocol Director, or a situation in which any investigator must report to or is under the professional supervision of the IRB member);
• Financial interest: if it involves: (a) receiving more than $10,000 annually as salary, consulting income, or other compensation related to the research; (b) having an equity interest (including stock or stock options) that exceeds $10,000 or that represents more than 5% of the company sponsoring the research; (c) having an ownership interest (including patent, trademark, or copyright interest) in the drug/product/technology that is the subject of the research project; or (d) receiving or expecting to receive compensation with a value that may be affected by the outcome of the study;
• Personal relationship with investigator (IRB member has an immediate family relationship or other close personal relationship with the investigator);
• Fiduciary relationship to sponsor (IRB member serves as an executive to a company sponsoring the research or serves on the company’s board of directors);
• Other nonfinancial interests that may be conflicting interests, such as if (a) the IRB member has an interest that he/she believes conflicts with the member’s ability to review a project objectively; or (b) the IRB member is in direct competition with the investigator for limited resources, funding, sponsorship, or research subjects, or the IRB member is considered a personal or professional adversary of the investigators (for (b), the IRB member must disclose the circumstances to the IRB Chair or CPHS Coordinator for a determination of whether a conflicting interest exists).
• Any other reason for which the IRB member believes he or she has a conflicting interest with the research.

PROCEDURES FOR PROTOCOL REVIEW AND ATTENDANCE AT THE IRB MEETING

• IRB members should review the list of projects for an upcoming meeting with the conflicts issue in mind and should disclose a conflicting interest as soon as possible to the IRB Chair or CPHS Coordinator. An IRB member with a conflicting interest in a project should not accept that project as an assigned review, and should return it to the IRB office for reassignment to another IRB reviewer.
• If an IRB member recognizes a conflicting interest in a project at the IRB meeting, the IRB member must inform the IRB Chair of the conflicting interest and leave the room during the discussion of and vote on the project.
• If other IRB members need to request information about the project from the IRB member with the conflicting interest, the IRB member may remain in the room during the presentation of the project. The IRB member must then leave the room during the IRB’s discussion and vote.
• CPHS Coordinator will record in the minutes a recusal based on a conflicting interest. The IRB member will not be counted as part of the quorum for the project. (Should the quorum fail, the IRB may not take further action or vote on the project.)

1. When is the Permission/Consent of Both Parents Required?
   Federal regulations for the protection of human subjects require (or permit the IRB to require) the permission of both parents for the participation of vulnerable subjects in the following research under the following circumstances (with exceptions as indicated):
   1. For any proposed study involving children, the IRB will determine whether the consent of both parents is necessary as an additional protection for child subjects. This determination may be made even in cases where the permission of both parents is not required by regulation. The IRB will notify the investigator whenever it determines that permission must be obtained from both parents.
   2. If the research presents more than minimal risk and offers no prospect of direct benefit to child participants (i.e., the research is categorized as 45 CFR §46.406/407 or 21 CFR §50.53/54).
      • Exception: Permission of one parent is sufficient if the other parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the care and custody of the minor child.
   3. If the research is DHHS-regulated, involves a pregnant woman and/or fetus, and offers the prospect of direct benefit solely to the fetus (45 CFR §46.204 (e)).
      • Exception: The father’s consent need not be obtained if he is unable to consent due to unavailability, incompetence, or temporary incapacity, or the pregnancy resulted from rape or incest.
   4. If the research is DHHS-regulated and involves a non-viable neonate (§46.205(c)(5))
      • Exception: The consent of one parent is sufficient if the other parent is unable to consent because of unavailability, incompetence, or temporary incapacity, and the father’s consent need not be obtained if the pregnancy resulted from rape or incest. Note that consent may not be waived or altered for minimal risk research involving a nonviable neonate.
2. May the IRB Waive Parental Permission? Under regulations applicable to DHHS-funded research, 45 CFR §46.408(b), the IRB may waive the requirement for parental permission if the IRB determines that such permission is not a reasonable requirement to protect the child subjects (e.g., the subjects are abused or neglected children) and the waiver is not inconsistent with applicable laws (e.g., the IRB may not waive the permission requirement for a procedure for which parental consent is required under state law). Note that FDA regulations do not permit such a waiver of parental permission.
3. Required Form of Permission Where the permission of both parents is required by regulation as described in Section I, and has not been waived by the IRB as described in Section II, such permission must be obtained in writing. As a general rule, the IRB expects investigators to involve both parents in a face-to-face consent discussion and to obtain the signatures of both parents on the consent form. If only one parent is present, the investigator must attempt to arrange for a consent discussion with the absent parent, and should document this attempt. When relying upon one of the exceptions listed in Section 1 to obtain permission from only one parent, the investigator should document the factual basis for the exception (e.g., reason why the second parent cannot provide permission) in detail in the research record.
4. When Only One Parent is Present
   1. Is the absent parent alive or legally responsible? When only one parent is present, the investigator should ask whether the other parent is living, and if so, whether the parents share custody and legal authority to make decisions on behalf of the child. • If the parent who is present responds that the other parent is deceased, unknown, or does not share custody and legal decision-making authority, permission from the custodial parent who is present with the child is sufficient, unless the investigator has evidence that would lead a reasonable person to question whether that parent’s response is credible. (In the latter case, the investigator should consult with legal counsel before enrolling the child).
   2. Is the absent parent incapacitated or incompetent? The investigator should apply the same “reasonable person” standard if the parent who is present responds that the other parent is available but unable to give permission due to incapacity or incompetence.
      • If the investigator is uncertain whether the parent who is not present truly lacks capacity (e.g., the parent is institutionalized or hospitalized but has not been declared incompetent), the investigator should follow the process described below for parents who are “not reasonably available.”
   3. Is the absent parent legally responsible and competent, but unavailable?
      • If the parent who is present (Parent A) can provide a phone number for the parent who is absent (Parent B), the investigator should telephone Parent B to discuss the study and to arrange to send consent forms for B’s signature. Parent B may receive the forms by mail or fax, and may mail or fax a signed consent form back to the investigator. The child may not be enrolled until the absent parent has returned the signed consent form to the investigator.
      • If no contact information is available for Parent B, or B does not respond to repeated attempts at phone contact (e.g., at least two messages over a 48 hr. time period), the investigator may consider Parent B to be unavailable, unless Parent B subsequently responds and refuses to give permission (at which point the child’s participation must end).
      • If Parent A has an address for Parent B, but no phone number, the investigator should send Parent B written notification that
        • Parent A is enrolling the child in a research study;
        • The investigator has been unable to reach Parent B by telephone; and
        • Parent B will be considered unavailable if he or she does not contact the investigator by a specified date (allow at least ten days from the date of the letter). The child may not be enrolled until the earlier of the date Parent B responds affirmatively or the date ten days after sending the notice with no response. If Parent B subsequently responds and refuses to give permission, the child’s participation must end.
   4. What if the investigator is unable to contact the absent parent? If the absent parent cannot be reached by telephone and the investigator has made repeated attempts over a reasonable time period (e.g., multiple attempts over a period of at least 48 hrs.), and no other contact information (e.g., address) is available, the investigator may determine and document that the parent is “not reasonably available.”
5. When Neither Parent has Custody of the Child. If neither of the parents has custody, the investigator should determine whether another individual or entity (e.g., Department of Social Services) has been awarded a guardianship that includes authorization to consent for the child to participate in medical research (or in the case of kinship caregivers and where the research involves medical treatment, whether the relative can provide a copy of the kinship care affidavit filed with DSS). In the absence of such a guardianship order (or kinship care affidavit), permission must be obtained from the court with jurisdiction over the child.
6. Research Involving Pregnant Women, Fetuses, or Nonviable Neonates In addition to the exceptions listed in Section I, above, the permission of the father is not required for research involving pregnant women, fetuses, or nonviable neonates, if the pregnancy was the result of rape or incest. The investigator may rely upon the mother’s representations about rape or incest unless the facts and circumstances would cause a reasonable person to doubt the mother’s credibility (in which case, the investigator should consult legal counsel before enrolling the subject).
7. If Parents Disagree If the investigator has succeeded in contacting the absent parent and that parent does not give his/her permission, or fails to sign and return the consent form, the child (or pregnant woman, fetus, or neonate, except in cases of rape or incest) may not be enrolled in the study, even if the parent who is present (or the pregnant woman, except in cases of rape or incest) has given permission.
8. Embryonic Stem Cell Research Although DHHS does not presently fund research involving the creation of new embryonic stem cell lines, and FDA regulations requiring informed consent apply only to clinical investigations of therapeutic products or other “test articles,” the Institute of Medicine has recently published voluntary ethical guidelines for such research. The IOM recommends that informed consent be obtained from any donor whose gametes will be used to create embryos for research. In addition, the IOM guidelines recommend that embryos (“blastocysts”) not be used in research without the consent of all gamete donors.

Research data generated while individuals are pursuing research studies as faculty, staff, or students of Stevens Institute of Technology, and data generated by visiting scientists utilizing the facilities of Stevens, are to be retained by the institution for a period of three (3) years after submission of the final report on the research project for which the data were collected, unless a longer retention period is specified by the sponsor.

The original research data may be retained by the senior investigator on behalf of the institution but must be returned to the institution upon request of an appropriate institutional official. Additionally, such data must be available to representatives of external sponsors of the research or designated governmental officials, when such access is appropriate. Such data must not be disposed of during the time period referenced above unless explicit written approval for such disposition is received from the Provost or a designee of such individual.

Information Related to Policy Statement

Research Data means recorded information, regardless of form or the media on which it may be recorded. The term includes computer software (computer programs, computer data bases, and documentation thereof), and data of a scientific or technical nature. The term does not include information incidental to award administration, such as financial, administrative, cost or pricing, or management information. In practice, scientific data include, but are not limited to, material contained in laboratory notebooks or other media such as computer disks and machine printouts. Data includes both intangible data (statistics, findings, conclusions, etc) and tangible data (notebooks, printouts, etc.).

Research Data is specifically limited to data generated under organized research funding (i.e., research activities which are separately budgeted and accounted for) and does not include departmental research (i.e., that not separately budgeted and accounted for).

OMB Circular A-110 ("Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations") specifies in section __.53(a) that financial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained by the institution. In an April 11, 1994 letter, OMB has stated that the term "all other records pertinent to an award" encompasses all records that were produced in connection with the award, including laboratory data and primary data.

Discussion

Stevens recognizes that the generators of data (faculty, staff, students) often believe that they own the data produced in their laboratories and that they have an interest in ensuring that the data are used in an appropriate manner. At the same time, the University recognizes that it has legal responsibilities with regard to access and retention of data, particularly data generated under sponsored agreements.

It is important that investigators be able to document the results of research, both for the sake of meeting legal requirements as well as for the more traditional reasons of establishing priority for patentable items, publishing manuscripts, etc. Senior members of research teams have obligations to discuss the responsibilities of data management and retention with other members of a research team. As a matter of practice, original data should be left with the senior investigator when a student leaves the institution, but copies of that data, where feasible to do so, should be provided to the student.

When an investigator leaves the institution, (s)he must recognize that the institution must have access to the data. It is neither feasible nor desirable for the original research records to remain at the originating institution, but departing investigators must understand that they have an obligation to hold these data in trust for the institution and that such data must be returned to the institution if requested for a period of three (3) years after submission of the final report on the research project for which the data were collected, unless a longer retention period is specified by the sponsor.

Investigators should be cognizant of the requirement to retain research data, but should recognize that certain information may be generated (for example, instrument test runs, set-up runs, etc.) which is not research data and therefore need not be retained. Reliance should be placed on discipline-specific standards and expectations and the judgment of the senior members of the research team.

The IRB is obligated to evaluate whether a research study is designed to minimize risks to participants and to determine that the potential benefits to the participants from the research justify those potential risks. This obligation is set forth in Department of Health and Human Services and corresponding FDA regulations, and supported by accepted ethical codes such as the Declaration of Helsinki of 2000 (sections 11, 18 and 29) and the Nuremberg Code of 1949 (point 3).

Federal research regulations [45 CFR 46.111(a) and 21 CFR 56.111(a)] include as criteria for IRB approval:

1. Risks to subjects are minimized:
   1. By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
   2. whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result.

The IRB should not approve a research protocol if:

• The study objectives can be achieved through procedures that pose less risk to participants;
• The study involves risks to participants and is not designed to ask a question that is important or asks a question that has already been answered by prior research; or
• The study design is likely to yield results of no discernible value (see below for exceptions related to protocols involving little or no risk to participants).

Scientific Review

Evaluation of the scientific aspects of a research study (e.g., statistical validity, prospect of study value) may require specific expertise. The IRB should assign protocols to reviewers who have the appropriate expertise to evaluate study design; however, depending on IRB membership background, and availability, this expertise may not be available or sufficient to address the complexities of a particular protocol. The IRB may rely, in part, on prior scientific review (e.g., NIH peer review, internal scientific committee reviews) as described in the Stevens’ Institutional Handbook of Procedures, Chapter 1. An expert may be asked to provide opinion as addressed in Chapter 4 - Section 4.15.

Minimization of Risks in Clinical Studies

Whenever possible, studies should utilize procedures that are already being performed on the participants for diagnostic or treatment purposes. Where this is not the case and the research procedure carries a high level of risk with no potential benefit to participants, the Investigator should be prepared to justify why the procedure is necessary to achieve the research objectives, or why enrollment should not be limited to those already scheduled for the procedure for non-research purposes. Certain types of clinical protocols may require special attention from the Investigator to minimize risks. Some examples are described below:

Placebo-Controlled Studies

A protocol that involves removing participants from the standard medication for their disease or condition, and randomizing them to receive either an investigational agent or a placebo, may raise issues of participant safety. If some participants will receive no potentially beneficial drug for all or a significant portion of the trial, the PD should specify in the protocol and consent form the nature and severity of the associated risk to those participants. Depending upon the degree of risk, the Investigator should consider modification of study design to minimize the risk. The study design might be modified to define a benchmark for unacceptable worsening of the participant's disease or condition, together with a monitoring plan for timely detection of participants who reach the benchmark and a "rescue mechanism" for ameliorating the participant's condition once the benchmark is reached. Alternatively, the Investigator might consider modifying the research design to include a cross-over design (from placebo to investigational drug and vice versa). Other design options include restricting eligibility to individuals who refuse, or have been shown not to respond to, the standard medication, or who have only a mild form of the disease or condition. In situations where the standard treatment is tolerated by and known to prevent serious harm such as death or irreversible morbidity in the participant population, the IRB may determine that a placebo design is not acceptable.

Active Control Studies

Study designs in which some participants receive the investigational agent but are removed from standard therapy for serious conditions may raise similar issues, as the investigational treatment may turn out to be ineffective. Unless there is strong reason to expect that the investigational drug will be at least as good as the standard therapy, consideration should be given to one of the design modifications discussed above.

Deliberate Induction of Undesirable States

Special measures should be in place to minimize risk in research that deliberately induces an undesirable state or condition in participants (e.g., pain, panic attack, allergic attack, a condition of airway narrowing) in order to learn more about the undesirable state or condition. The IRB, with expert advice as needed, will scrutinize thoroughly the design aspects of such research to ensure that adequate measures have been instituted to minimize participant risks.

Protocols Involving Little or No Risk to Participants

Judgment and common sense also have a place in determining whether to approve a research protocol. The IRB reviews a large volume of social science research conducted by students. Many of these protocols pose little or no risk to the participants (e.g., surveys that ask the participant non-sensitive questions). If a student’s study design is flawed (e.g., not likely to render the information necessary to answer the research question), the IRB may make recommendations to improve study design, but it is not bound by ethical guidelines to not approve such research.

Sources and Resources

• Additional guidance on sound study design is available at Stevens and in published resources. Following is a list of potential resources.
• Contact the CPHS Coordinator for more information about these and other resources.
• OHRP Institutional Review Board Guidebook, Chapter IV Conditions of Research Design
• Institutional Review Board Management and Function, by Robert J. Amdur and Elizabeth A. Bankert, Jones and Bartlett Publishers, 2006.
• Institutional Review Board Member Handbook, by Robert J. Amdur and Elizabeth A. Bankert, Jones and Bartlett Publishers, 2007.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation; or (iii) the research involves the use of children as subjects (legal age of consent in the State of New Jersey is 18 years old).
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph 2 of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits to services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) research on drugs for which an investigational new drug application (21 CFR Part 312) is required. (*Note: research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.); or (b) research on medical devices for which (i) an investigational device exemption application (21 CFR 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with clearer/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children (as defined by the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in this research, under the applicable law of the jurisdiction in which the research will be conducted), considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at a delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skill cells collected by buccal scaping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
8. Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and additional risks have been identified.

Background
If research is funded, supported by or otherwise subject to certain federal agencies or agreements, it could be subject to additional requirements to those in the Common Rule.

Please consult with the Office of Sponsored Programs for specific questions in this area.

Scope
This guidance addresses requirements for research supported by or otherwise subject to, the following federal departments and agencies:

• Department of Defense (DOD)
• ONR (Navy)
• Department of Education (ED)
• Department of Energy (DOE)
• Department of Justice (DOJ)
• Environmental Protection Agency (EPA)

Links to other federal agencies are shown as follows:

REGULATIONS, DIRECTIVES, INSTRUCTIONS AND POLICIES FOR THE
PROTECTION OF HUMAN SUBJECTS IN RESEARCH

• Department of Health, Education and Welfare (DHEW) Notice of Report, “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”, 18 April 1979. (the “Belmont Report”)
  http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

• Department of Health and Human Services (DHHS) Regulation, Title 45 CFR Public Welfare, Part 46: “Protection of Human Subjects”, 23 June 2005. (the “Common Rule”) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
• Department of Defense (DoD) Regulation, Title 32 CFR Part 219: “Protection of Human Subjects”, 19 August 1991.
  http://www.dtic.mil/biosys/downloads/32cfr219.pdf http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

• Federal Drug Administration (FDA) Regulation, Title 21 CFR Part 50: “Protection of Human Subjects”, 1 April 2006.
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&sho

• Federal Drug Administration (FDA) Regulation, Title 21 CFR Part 56: “Institutional Review Boards”, 1 April 2006.
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&sho

• Title 10 CFR Armed Forces: Subtitle A: General Military Law, Part II, Chapter 49, Section 980 “Limitation on Use of Humans as Experimental Subjects”, 30 May 2006.
  http://www.law.cornell.edu/uscode/10/usc_sec_10_00000980----000-.html

• Department of Defense (DoD) Directive 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research”, 25 March 2002. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

• Department of Defense (DoD) Directive 6200.2, “Use of Investigational New Drugs for Force Health Protection”, 24 November 2003.
  http://www.dtic.mil/whs/directives/corres/pdf/d62002_080100/d62002p.pdf

• Secretary of the Navy Instruction, SECNAVINST 3900.39D, “Human Research Protection Program”, http://www.onr.navy.mil/sci%5Ftech/34/docs/secnavinst_3900_39d.pdf
• Department of Defense (DoD) Directive 3210.7, “Research Integrity and Misconduct”, 14 May 2004. http://www.dtic.mil/whs/directives/corres/pdf/i32107_051404/i32107p.pdf
• U.S. Naval Academy Academic Dean and Provost Instruction, ACDEANINST 3920.3, “Integrity in Research and Scholarly Activity”, 4 February 2000. l. Secretary of the Navy Instruction, SECNAVINST 5210.8D, “Department of the Navy
• Records Management Program”, 31 December 2005.
  http://doni.daps.dla.mil/Directives/05000%20General%20Management%20Security%20an         d%20Safety%20Services/05200%20Management%20Program%20and%20Techniques%20Services/5210.8D.pdf

• Secretary of the Navy Instruction, SECNAVINST 5211.5E, “Department of the Navy (DoN) Privacy Program”, 28 December 2005.
  http://doni.daps.dla.mil/Directives/05000%20General%20Management%20Security%20an
  d%20Safety%20Services/05200%20Management%20Program%20and%20Techniques%2
  0Services/5211.5E.pdf

• Federal Privacy Act (5 USC 301, 552a (1994)).
  http://www.law.cornell.edu/uscode/search/display.html?terms=552(a)&url=/uscode/html/uscode05/usc_sec_05_00000552---a000-.html

• Department of the Navy Human Research Protection Program (DoN-HRPP) “Education and Training Policy for Research Ethics and the Responsible Conduct of Research”, 9 November 2006.
  http://www.onr.navy.mil/sci%5Ftech/34/docs/DON_HRPP_policy_0611.pdf

• Department of Health and Human Services (DHHS), Office for Human Research Protections Guidance on Continuing Review, 15 January 2007
  http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm

• Department of Defense (DoD) Directive 5230.9, “Clearance of DoD Information for Public Release”, 9 April 1996.
  http://www.dtic.mil/whs/directives/corres/pdf/523009_040996/523009p.pdf

• Revised Policy for IRB Review of Human Subject Protocols at the National Institutes of Health (NIH), 1 May 2000.
  http://grants2.nih.gov/grants/funding/phs398/instructions2/p2_irb_approval.htm

Department of Defense
Department of Defense (DOD) Research
Guidance for Investigators

Research sponsored by the Department of Defense (DOD), involving collaboration with DOD, or involving DOD facilities or personnel (military or civilian) is subject to special requirements for human subjects protections.  These special requirements are summarized in this guidance.

Investigators must be aware of these special requirements when planning a research project as they may add a significant amount of time to the human subjects’ review and approval process.

For DoD-sponsored research, information regarding the specific requirements of the DOD Component should be available from the granting agency.

Please note that the Stevens Office of Sponsored Programs (OSP) may be required to submit IRB approval to the human subjects’ protection unit of the DOD funding agency before an award can be activated.

2. What is Department of Defense Research?
Research is considered to involve the Department of Defense when:

• The research is funded by a DoD Component (see the list below)
• The research involves cooperation, collaboration or other type of agreement with a DoD Component, including subawards to Stevens from another institution receiving the direct award from DoD
• The research uses property, facilities, or assets of a DoD Component
• The subject population will intentionally include personnel (military and/or civilian) from a DOD Component. (DOD requirements do not apply when DOD personnel incidentally participate as research subjects where they are not the intended research population or where the project is not DoD-supported).

DoD Components include but are not limited to:

• Air Force
• Air Force Academy
• Army
• Army Corps of Engineers
• Coast Guard
• Coast Guard Academy
• Defense Advanced Research Projects Agency (DARPA)
• Defense Intelligence Agency
• Marines
• Military Academy (West Point)
• Missile Defense Agency
• National Geospatial-Intelligence Agency
• National Guard
• National Security Agency
• National War College
• Naval Academy
• Navy
• Office of Naval Research
• Pentagon Force Protection Agency
• Tricare Health System
• U.S. Naval Observatory

3. Special Requirements for IRB Review of DOD Research
Each DOD Component may provide additional guidance about specific requirements.  Most of the Component specific requirements are included in this guidance, but PIs are advised to check with the sponsoring Component about any additional requirements.

3.1 Training Requirements
DOD requires that all individuals involved in the “design, conduct, or approval of human subjects’ research” complete human subjects’ research training. Stevens’ human subjects’ research training, renewed every three years, meets the training requirements for many DoD Components.  Investigators are responsible for ensuring that all study team members engaged in the conduct of human subject research complete Stevens’ training.

Component specific training:
Department of Navy (DON) (including Marine Corps)
Principal investigators for projects sponsored by or involving DON Components must complete additional training offered by CITI, specifically the CITI Training Module for DON-Supported Extramural Performers.  Refresher training must be completed every three years.

The training requirement for other study staff engaged in DON research can be met by either PEERRS or CITI training.

Secretary of Defense (Personnel and Readiness)
All investigators and research staff on projects sponsored by the Secretary of Defense (Personnel and Readiness) are required to complete annual human subjects’ protection training.  Completion of CITI training is required with refresher training required every three years.

3.2 Scientific Review
Research involving components of the Army or Navy (including Marine Corps) may require documentation of scientific review prior to IRB review of new applications and substantive amendments.

The scientific review may be the review provided by the funding agency (including DOD), by an internal review mechanism in the researcher’s academic unit, or in the form of an ad hoc review by the researcher’s chair or dean.

Scientific review must demonstrate that the research uses procedures consistent with sound research design and is likely to yield the expected results and should include the assessment of the following elements:

• Significance of the research question
• Scientific approach
• Research team qualifications
• Facilities and resources available

Documentation of the scientific review must be provided to the IRB at the time the IRB application is submitted.  The name and qualification of the reviewer(s) should be included a part of the review.

3.3 DoD Approval of Surveys/Interviews
Research involving the administration of surveys or interviews to DOD personnel (military or civilian) or their families may require DOD approval.  Check with the DOD Component regarding any additional review requirements and provide documentation of survey/interview approval or waiver of the review requirement from the DOD Component to the IRB.
3.4 Research Monitor (more than minimal risk research)
A research monitor is required for all research that involves more than minimal risk.  The monitor may be either a medical or non-medical monitor depending on the nature of the research.  The monitor must be independent of the research team and possess sufficient expertise to evaluate the risks and conduct of the research.  The investigator must identify a research monitor and have the selection approved by the reviewing IRB.

The duties of the monitor are determined based upon the specific risks or concerns associated with each research project.  Examples of monitor activities include assessment of subject recruitment and enrollment, data collection or data storage, and analysis. The monitor may be asked to discuss research progress with the investigator, interview subjects, or evaluate adverse events.

The Institutional Official of the DOD Component may waive the requirement for the monitor.

3.5 International Research
For Navy-sponsored research that involves subjects who are not US citizens or DOD personnel, the investigator must provide the following documentation:

• Permission of the host country, and
• Ethics review and approval by the host country or the local Naval IRB with host country representation.

3.6 Collaboration with other Institutions
Investigators must provide the following information about any collaborating institutions:

• Documentation of IRB approval from engaged collaborators
• Statement of compliance with special DoD requirements (See the U-M DoD addendum)

4. Unique Subject Protections Required for DoD-related Research
4.1 Prohibited Research

• Research with Detainees (prisoners of war), except research with investigational new drugs or devices where such treatment would also be offered to US military service members at the same location and with the same medical condition consistent with established medical practice.
• Classified Human Subjects Research
• Human testing of chemical or biological agents, except for certain prophylactic, protective or peaceful purposes.

4.2 DoD Personnel as Research Subjects
                4.2.1 Military Participants

• Adult status - All active duty service members and reserve component members are considered to be adults for the purpose of participating in DoD-conducted or supported research.

• Command approval - Command approval may be required for military personnel to participate in human subjects’ research as some types of research could impact a soldier’s readiness in the field. Investigators may be asked to provide documentation of Command approval.
• Protection of service members from undue influence - Superiors may not influence the decision of subordinates to participate in human subjects’ research and may not be present at time of recruitment. Superiors must be recruited in a separate session from subordinates.

For more than minimal risk research and where recruitment is conducted in a group setting, an ombudsman must be present to ensure that information is presented clearly, accurately, and adequately and that the voluntary nature of participation is emphasized. The ombudsman may be the same individual appointed by the IRB as the research monitor.

               
                4.2.2 DOD Civilian Personnel
DOD civilian personnel being recruited into research are afforded the same protections as military personnel (4.2.1 above). The requirement for an ombudsman is at the discretion of the IRB.

                4.2.3 Limitations on Compensation
On-duty federal personnel including military members

• Up to $50 for blood draws
• No compensation for general research participation

                                Off-duty federal personnel including military members

• Up to $50 for blood draws
• Compensation for general research participation as approved by the IRB can be paid but not directly from a federal source. Payment from a federal contractor or non-federal source is permissible.

                                Non-federal personnel

• Up to $50 for blood draws

Compensation, as approved by the IRB, is allowable for general research participation.  Payment may come from a federal or non-federal source.

4.3 Unique DOD Limitations of Waivers of Informed Consent and Consent by Legally Authorized Representatives (LARS)
The requirement to obtain consent cannot be waived for any research using DoD funds and meeting the definition of research involving a human being as an experimental subject (10 USC 980), meaning “an activity, for research purposes where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction.”  This places limitations on research involving deception, decisionally-impaired individuals, or research being conducted under emergency conditions where the subject may not be able to provide consent.

This statute applies only to certain intervention studies.  It does not apply to retrospective research involving analysis of data or specimens, observational studies, blood draws, or tissue collection, and does NOT apply to screening of records to identify possible subjects.  The IRB may grant a waiver of consent for such activities.

The Secretary of Defense may waive this consent requirement for a specific project in order to advance the development of a medical product necessary to the Armed Forces, but only if the research may directly benefit the subject and the research is carried out in accord with all other applicable laws and regulations.

Informed consent may be provided by a legally authorized representative (LAR) only if: (1) the subject lacks decision-making capacity; AND (2) the IRB has determined that the research is intended to be beneficial to the individual subjects.

4.4 DoD Protections from Medical Expenses if Injured
For more than minimal risk research, subjects must be provided information regarding payment of medical expenses, provision of medical care, or compensation for research-related injuries, consistent with the requirements of the Common Rule.

5. Other DoD-Specific Requirements
5.1 Recordkeeping
Consistent with Stevens’ policy, research records must be maintained for at least 3 years after the completion of the research.  The DOD may require that research records be transferred to the DOD component rather than being retained by the University.
DoD Component Requirements
Department of Defense, Office of the Secretary of Defense for Personnel and Readiness
HA Policy 05.003, Policy for Protection of Human Subjects in Department of Defense Sponsored Research
Department of the Army
AR 70-25, Use of Volunteers as Subjects of Research, January 25, 1990
AR 40-38, Clinical Investigation Program, September 1, 1989
AR 40-7, Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances, October 19, 2009
Department of the Navy
SECNAV Instruction 3900.39D, Human Research Protection Program, November 6, 2006
Department of the Navy, Training and Education Guidance, April 15, 2011
Department of the Air Force
Air Force Instruction 40-402, Protection of Human Subjects in Research

REFERENCES

DOD Regulations and Guidance

1. 32 CFR 219, Protection of Human Subjects
2. DoD Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, November 8, 2011
3. 10 USC 980, Limitations on the Use of Humans as Experimental Subjects
4. Department of Defense Directive 3210.7, Research Integrity and Misconduct
5. Department of Defense Directive 6200.2, Use of Investigational New Drugs in DOD Force Health Protection

Department of the Navy

Applicability and Scope
[DoDD 3216.2, para 2.2 and 4.3.1; SECNAVINST 3900.39D para 4a(l) and 6g] DoDD 32 16.2
2.2: Applies to research involving human subjects, as defined herein, conducted by a DoD Component (i.e.,intramural) and other research that is supported by a DoD Component (i.e., extramural) through a contract, grant, cooperative agreement, or other arrangement.

4.3.1: The Department of Defense has joined with other Federal Agencies to adopt the "Common Rule" Federal policy for protection of human subjects in research. 32 CFR 2 19 is the Department of Defense's implementation of the Common Rule. All DoD-supported and DoD-conducted research shall comply with 32 CFR 219 and this Directive.

SECNAVINST 3900.390, para 4a(l) and 6g 4a(l): This instruction applies to: All biomedical and social-behavioral research involving human subjects conducted by Navy and Marine Corps activities or personnel, involving naval military personnel and DON employees as research subjects, or supported by naval activities through any agreement (e.g., contract, grant, cooperative agreement, or other arrangement), regardless of the source of funding, funding appropriation, nature of support, performance site, or security classification. It also applies to human subject research using DON property, facilities, or assets.
6g: DON supports research with human subjects conducted at non-federal institutions. Any research grants, contracts, cooperative agreements, Cooperative Research and Development Agreements (CRADAs), or other transactions must include the additional DoD and DON requirements for human subject protections.

Specific Citations for Key Additional Requirements
1. Initial and continuing research ethics training for all personnel who conduct, review, approve, oversee, support, or manage human subject research [DoDD 3216.2, para. 4.5; SECNAVINST 3900.39D, para. 6a(2)]
DON HRPP- Addendum to FWA Addl Requirement List - FINAL - 13 Feb 2007.doc
2. Written determination by a designated official (other than investigators) whether research meets criteria for exemption [SECNAVINST 3900.39D, para. 6c]
3. New research protocols and substantive amendments to approved research must undergo scientific approval prior to ethics (IRB) review [SECNAVINST 3900.39D, para. 8c(6)]
4. Procedures for addressing conflicting and competing interests [DoDD 3216.2, para. 4.4.4; SECNAVINST 3900.39D, para. 6b]
5. Appointment of Medical Monitor [DoDD 3216.2, para. 4.4.31
6. Provisions for research-related injury [DoDD 3216.2, para. 5.3.4; SECNAVINST 3900.39D, para 6a(5)]
7. Additional protections for military research subjects to minimize undue influence [DoDD 3216.2, para. 4.4.4; SECNAVINST 3900.39D, para 6a(6)]
8. Additional protections for pregnant women, prisoners, and children (Subparts B, C, and D of 45 CFR 46) DoDD 3216.2, para. 4.4.1; SECNAVINST 3900.39D, para. 6a(6]
9. Additional safeguards for research conducted with international populations [DoDD 3216.2, para. 4.9; SECNAVINST 3900.39D, para. 6i] 10. Limitations on research where consent by legally authorized representatives is proposed [DoDD 3216.2, para. 4.2.; SECNAVINST 3900.39D, para. 6a(3);10 U.S.C 9801
11. Limitation on exceptions from informed consent in emergency medicine research [DoDD 3216.2, para. 4.2; SECNAVINST 3900.39D, para. 6a(3)and 7a(l); 10 U.S.C. 9801 12. Limitations on compensation for U. S. military personnel [Dual Compensation Act and 24 U.S.C 301 13. U. S. Navy-wide survey research requires additional review [SECNAVINST 3900.39D, para. 6e; OPNAVINST 5300.8Bl
14. Requirements for reporting unanticipated problems, adverse events, and research-related injury SECNAVINST 3900.39D, para 8d(2), para. 8e(6), and para. 8g(6)]
15. Oversight by the DON HRPP through headquarters-level review of research protocols (including relevant IRB meeting minutes) after local institutional approval and site visit of the institution's HRPP [DoDD 3216.2, para. 5.3.3; SECNAVINST 3900.39D, para. 6g , 8b, and 8d] DON HRPP- Addendum to FWA Addl Requirement List - FINAL - 13 Feb 2007.doc
16. Recordkeeping requirements
[DoDD 3216.2, para. 5.3.2; SECNAVINST 3900.39D, para. 8c(18)] Recordkeeping requirements for DON-supported research with human subjects are longer than the Common Rule's requirement. The DON HRPP is developing policy guidance.
17. Addressing and reporting allegations of non-compliance with human research protections [DoDD 3216.2, para. 4.10; SECNAVINST 3900.39D, para. 8d(2) and 6k; ] 18. Addressing and reporting allegations of research misconduct [DoDD 3216.2, para. 4.8; DoDD 3210.7; SECNAVINST 3900.39D, 8d(2)para. 611
19. Provisions for research with human subjects using investigational test articles (drugs, device, and
biologics) [DoDD 3216.2, para. 4.9; DoDD 6200.2; SECNAVINST 3900.39D, para. 6h] 20. Prohibition of research with prisoners of war (POW) and detainees [DoDD 3216.2, para. 4.4.2; SECNAVINST 3900.39D, para. 6a(8)]
2 1. Classified Research
[SECNAVINST 3900.39D, para 6j]
DON

Department of Education

Obtaining Student Records or Personal Education Information
When researchers obtain student records or personal education information from an education program (as defined in 34 CFR 99.3), such activity is subject to the Family Educational Rights and Privacy Act (FERPA).
• 34 CFR 99.3 [FERPA Definitions]

Releasing Records without Consent

An educational institution may disclose personally identifiable information from an education record of a student without consent under certain conditions as listed in FERPA.
• 34 CFR 99 [FERPA]

Protection of Students
No student shall be required, as part of any program specified in §98.1 (a) or (b), to submit without prior consent to psychiatric examination, testing, or treatment, or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning certain topics.
• 34 CFR 98.4

Protection of Pupil Rights
Inspection of instructional materials by parents or guardians;
Limits on survey, analysis, or evaluations;
Local policies concerning student privacy, parental access to information, and administration of certain physical examinations to minors.
• 20 U.S.C. Ch.31, Subchapter III, Part 4, § 1232h especially (a),(b),(c)(1) (as was amended by PUBLIC LAW 107–110—JAN. 8, 2002 115 STAT. 2083)

Access to Instructional Material Used In Research
All instructional material—including teachers' manuals, films, tapes, or other supplementary instructional material—which will be used in connection with any research or experimentation program or project shall be available for inspection by the parents or guardians of the children engaged in such program or project.
• 34 CFR 98.3

Other Department of Education Requirements that are Congruent with Current HRPP Policies
Representation for Vulnerable Subjects on the IRB
When an IRB reviews research that purposefully requires inclusion of children with disabilities or individuals with mental disabilities as research subjects, the IRB must include at least one person primarily concerned with the welfare of these research subjects.
• 34 CFR 356.3

Department of Energy

Contractor Requirements
Regardless of the performer of the work, the contractor is responsible for compliance with the requirements of the Contractor Requirements Document (CRD), including periodically conducting self-assessments to ensure compliance with the Human Subject Research Program procedures and other requirements.
There is required prompt reporting to the DOE Human Subjects Research Program Manager for specified events.
• DOE 443.1B [Contractor Requirements Document: Protection of Human Subjects]

Required Checklist for Researchers

Researchers submit a checklist for IRBs to use in verifying that HS research protocols comply with DOE requirements, including those for protection of Personally Identifiable Information
• DOE Checklist to Verify Compliance with DOE Requirements

Department of Justice

Pilot Projects not Considered Research
For research conducted within the Bureau of Prisons, the implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.
• 28 CFR 512.10

28 CFR 512 - Judicial Administration Regulations
Research supported by DOJ shall comply with the Judicial Administration regulations covering research, 28 CFR 512 (“Subpart B”).
• 28 CFR 512

Research Design
A project must have an adequate research design and contribute to the advancement of knowledge about corrections.
• 28 CFR 512.11(a)(2)

Participant Protections and Payment
Risk to subjects minimized and reasonable in relation to anticipated benefits
Selection of subjects within any one institution must be equitable.
When applicable, informed consent must be sought and documented.
There may be no incentives to persuade inmate subjects to participate (soft drinks and snacks to be consumed at the test setting allowed): Reasonable accommodations may be offered to non-confined research subjects when certain criteria are met.
• 28 CFR 512.11(a)(4,5)

National Institute of Justice (NIJ) funded research
All projects are required to have a Privacy Certificate approved by the NIJ Human Subjects Protection Officer, and all researchers and research staff are required to sign Employee Confidentiality Statements, which are maintained by the responsible researcher (PD).
Research conducted with the Bureau of Prisons must follow regulations for the receipt, use, and storage of individually identifiable information.
Regulations prohibit the use of electronic storage/retrieval systems under certain circumstances.
• 28 CFR 22, 28 CFR 512.8,11,12,13,15

Informed Consent Requirements
Requirements for the consent process, including required elements for written consent document:
• 28 CFR 512.16

Researcher Experience
For research conducted within the Bureau of Prisons, the researcher must have academic preparation or experience in the area of study of the proposed research.
• 28 CFR 512.11(a)(6)

Content of research proposal
For research conducted within the Bureau of Prisons, when submitting a research proposal, certain specified items of information must be provided by the applicant, including a statement regarding assurances and certification required by 28 CFR 46, if applicable.
• 28 CFR 512.12

Investigator Responsibilities
The researcher must assume responsibility for actions of any person engaged to participate in the research project as an associate, assistant, or subcontractor to the researcher.
• 28 CFR 512.11(a)(7)

Progress Reports and Publication
Requirements for reports of progress, and (at least annually) of findings;
Publication of research results; Copyright provisions.
• 28 CFR 512.19 (Reports)
• 28 CFR 512.20 (Publication of results of research project)

Environmental Protection Agency

Exposure to Substances; Protections for Pregnant Women, Children, and Others
EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children to any substance.
EPA requires application of 40 CFR 26 Subparts C and D to provide additional protections to pregnant women and children as participants in observational research, i.e., research that does not involve intentional exposure to any substance.
Before the research can begin IRB determinations and approval must be submitted to the EPA Human Subjects Research Review official for final review and approval.
For research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:

• The provisions of 40 CFR 26 are extended to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance,
• The intentional exposure of pregnant women, nursing women, or children to any substance is prohibited.

• 40 CFR 26, 40 CFR 26.201-203, 40 CFR 26.304, 404-405,
• 40 CFR 26.1101-1125 (Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults)
• 40 CFR 26.1201-1203 (Subpart L—Prohibition of Third-Party Research for Pesticides Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women)

Children in Observational Research Greater than Minimal Risk but with Prospect of Direct Benefit
Such research is allowable if:

• The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.
• The risk is justified by the anticipated benefit to the participants.
• The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.
• Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in §26.406. 40 CFR 26.304, 40 CFR 26.404-405

• 40 CFR 26, 40 CFR 26.201-203 (Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women)
• 40 CFR 26.304 (Additional protections for pregnant women and fetuses involved in observational research)

The following is a discussion of the responsibilities for use of human subjects in student projects, pilot studies and oral histories (non-medical), and describes conditions under which CPHS review and approval may, or may not, be needed.

Over time, several types of studies have often raised questions with respect to investigators' responsibilities and the need to obtain prospective review and approval of the CPHS:

• Student Projects,
• Pilot Studies
• Oral Histories.
• Third Party
• Expert Opinion
• Autobiography or Auto-ethnography

These studies are sometimes less formal than other kinds of projects, and there can be confusion as to when or if they should be reviewed. Problems can arise when projects aren't reviewed when they should be.

HUMAN SUBJECT RESEARCH:
See Determining if Activities Meet Organizational Definition of Human Subject Research (pdf file)

1. STUDENT PROJECTS
   
   Stevens supports a wide range of both undergraduate and graduate student research projects using human subjects -- from course-related research exercises to Ph.D. dissertation studies. Generally, student research involving human subjects falls into one of two categories:
   
   RESEARCH PRACTICA, the goal of which is to provide research training. Research Practicum is a course of study that involves the supervised practical application of previously studied theories of research method (based on Webster's New Collegiate Dictionary). A number of departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these course projects is to train students and provide them with a closer view of social, educational, or psychological processes, and an opportunity to practice various research methods. Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Therefore, the CPHS does not consider them to be research and CPHS review and approval are not required.
   
   Although the CPHS does not review such class projects, we strongly encourage instructors to become fully familiar with each student's project(s), and to discuss it with the student. Experience indicates that time spent with students discussing matters such as courtesy, and avoidance of unnecessary discomfort or invasion of privacy, will be time well spent. We believe that explicit recognition of the existence of Human Subjects Review Boards at all research institutions, and discussion of their goals and concerns, should be an integral part of introducing students to research methodologies.
   
   DIRECTED OR INDEPENDENT RESEARCH PROJECTS (e.g., undergraduate honors or graduate theses), which employ systematic data collection with the intent to contribute to generalizable knowledge. These are research projects and do require IRB review and approval. If you have questions regarding the distinction between these categories, please do not hesitate to contact the CPHS Coordinator for assistance.
2. PILOT STUDIES
   As the IRB interprets the concept, a PILOT STUDY is a preliminary investigation of the feasibility of a study, usually done on a small scale (fewer than 10 subjects) and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. At the point of academic discussions, e.g., "how could this survey question be misunderstood," such a pilot would not contribute to generalizable knowledge. It is not considered research and does not require IRB review;
   
   HOWEVER………………….
   
   The IRB has encountered cases in which information derived from pilot studies has been considered or used for research purposes, i.e., publication. The IRB urges investigators preparing pilot studies to weigh the likelihood that the pilot data will actually be used for research purposes. Additionally, the Veterans Administration (VA) does not recognize the concept of ‘pilot projects’ and requires IRB review for ALL human subject interaction. In those instances, IRB review and approval is required before data collection commences.
3. ORAL HISTORY
   ORAL HISTORY is a technique in which the researcher conducts a series of taped interviews with the participants in a particular historical event or period. Often, the intention is that these tapes become available to the public at a specified future time (frequently after a substantial delay) in order to convey historical insight.
   
   In many cases, these interviews will be historical recollections of the character of a society or an institution rather than the interviewee's subjective perceptions. Such activities may or may not be considered human subjects research. While the IRB wants to avoid interfering inappropriately with the researcher's or interviewee's freedom of expression, oral history projects should be submitted to the IRB to determine the appropriate level of review. (In many cases, these projects may meet the requirements for Exempt Review Procedures.) Special considerations for oral history projects include:
   1. Are the conditions of use or publication of the recording clearly understood in advance by the interviewee?
   2. Is the interviewee given an opportunity to provide effective consent to the interview?
   3. Are adequate means provided for the protection of the privacy of any third parties who may be named in the interview?
4. THIRD PARTY
   In the course of their research, investigators sometimes collect information about persons other than the participant who has provided informed consent to be part of a study. For example, medical histories often collect information about conditions and diseases among a person’s relatives. Sociological, anthropological, or psychological research may obtain information about people’s experiences and perspectives on others in their lives. Persons who are not primary subjects of research, but about whom information is collected are sometimes referred to as “third parties” or “secondary subjects.” The IRB will consider on a case-by-case basis the circumstances under which third parties should be considered research subjects.
5. EXPERT OPINION
   Faculty, staff and students sometimes solicit the opinions of experts through phone or face-to-face interviews, surveys, and panel discussions. Experts are persons who, by virtue of their training or expertise, have information and knowledge in a substantive area beyond that of the average person and who regularly share this information and knowledge through consultation, teaching, public speaking, or publications and written reports. For IRB purposes, experts are not human subjects when asked to provide information and opinions within their areas of expertise on project design or share the benefit of their experience. Communications with experts in the ways just described do not require IRB approval;
   
   HOWEVER……..
   
   the IRB has encountered cases in which information derived from experts has been used for research purposes, i.e., publication at which point it does become subject to 45 CFR 46. If you have questions regarding the distinction between these circumstances, please do not hesitate to contact the CPHS Coordinator for assistance.
6. AUTOBIOGRAPHY OR AUTO-ETHNOGRAPHY
   In sociology, anthropology and related disciplines, postmodern ethnography, autobiography, or auto- ethnography is a narrative method in which the investigator and “subject” are one and the same. That is, the investigator reports on his/her own experiences and perspectives. In this form of narrative reporting, the investigator is not considered a research subject, and IRB approval is not required.

OTHER TYPES OF RESEARCH

Research conducted in conjunction with program evaluations or quality assurance measures may or may not fall under the jurisdiction of the IRB Committee for the Protection of Human Subjects (CPHS). If such a project is conducted with the intent to develop or contribute to generalizable knowledge, it should be submitted for review. For clarification, please feel free to contact the CPHS Coordinator to discuss the details of your project. WHO CAN I CALL IF I HAVE QUESTIONS CONCERNNING MY NON-MEDICAL HUMAN SUBJECTS RESEARCH? You can call the CPHS Coordinator at 201.216.5280, or the Director of Research Data, Audit and Compliance at 201.216.5371

• Determine with the Chair the type of expertise needed to review the protocol
• Assess if there is another IRB member who has the expertise that is needed
• If an IRB member with the needed expertise is not available, you may be able to obtain the needed expertise through a faculty member at Stevens. The CPHS Coordinator will assist in identifying a candidate
• If the needed expertise is not available within Stevens, the IRB Chair and the CPHS Coordinator will work together to identify and obtain a consultant outside the University
• When an individual with the needed expertise has been identified, the CPHS Coordinator will contact the individual to determine if he/she would be willing to review the protocol, whether the individual is available, and whether there might a conflicting interest
• In order to determine a potential conflicting interest, a few initial probe questions should be asked:
  • “Would you be willing to review a protocol for the Stevens IRB regarding (protocol purpose)?” If “YES,” continue….
  • “Are you available to review the protocol by (due date)?” If “YES,” continue….
  • Refer to the “Definition of Conflicting Interest (Guidelines for IRB Member on Conflicting Interests)” to review potential conflicting interest with the individual, and ask if reviewing the protocol might lead to a conflicting interest situation
  • If there is, or might be, a conflicting interest for this individual, consult with the Chair to select another potential expert and repeat the process

Federal regulations require that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.” (45 CFR 46.116; 21 CFR 50.20)

While no clear line distinguishes between proper and unreasonable payments and what may be excessive in one situation may not be in another, payment amounts should be reasonably commensurate with the time and effort required of the participants in the study.  Undue influence occurs “through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture” (Belmont Report).

Paying research participants for their participation is a common and, in general, acceptable practice.  Payment for research participation should be just and fair and should not be promoted as a way of offsetting risks, meaning it should not be considered a benefit to be weighed against the study risks.  The level of payment should not be so high as to cause a prospective participant to accept risks that he or she would not accept in the absence of the payment.
Protocols submitted to the IRB should indicate and justify proposed levels and purposes of payment, pursuant to the following four categories:

• Reimbursement for direct expenses (e.g. actual costs for parking, meals, lodging and transportation).  If the amount a participant will be reimbursed is limited, include this information in the consent form.
• Compensation for time and inconvenience (e.g. payment in an hourly amount for all or some of the hours required of the research participant that represents time away from work).
• Appreciation payments at token levels or token gifts (e.g. movie coupons, toys, gift certificates – amounts under $25.)
• Incentive payments (designed to act as incentives and are in amounts above the participant’s actual costs incurred and above token levels.)

In general, reimbursement for direct expenses, compensation for time and inconvenience in reasonable amounts and token gifts are usually justifiable and acceptable forms of payment.  It is when proposed payment amounts are not reasonably related to the time and effort required of participants that financial considerations may become a coercive factor or unduly influence a participant’s decision to participate in research.  To avoid unduly influencing decisions about research participations, incentive payments should be in reasonable amounts.

When children are research participants, consider whether the payment will be made to the parent(s) or the child, or both.  If the child is paid, be aware of the different ways children of varying ages view the value of a payment and ensure the payment is age-appropriate.

In research that involves considerable time duration or that involves multiple interactions or interventions, it is recommended that payment be prorated over the course of the study, rather than holding payment until study completion.  Conditioning payment on completing the study could unduly influence a participant’s decision to exercise his or her right to withdraw at any time.

The following is provided as guidance to the Stevens community when subjects will be recruited for a human subjects’ research protocol.  These elements are also criteria that the CPHS members may use when reviewing the recruitment technique proposed by an investigator.

 The investigator should consider the following elements:

• Purposes of the research
• Research environment
•  Recruitment methods and materials
• Payment arrangements
• Timing of the consent process
•  Inclusion/exclusion criteria
• Whether participants may be susceptible to coercion or undue influence
• Whether a population that stands no chance of benefiting is being selected to assume the risk.

Recruiting special subject populations
Vulnerable participants:

• Provide a rationale for involvement of vulnerable subjects, such as children, prisoners, pregnant women, economically and educationally disadvantaged, decisionally impaired, and homeless people, and
•  Address why a less vulnerable population would not serve as well.

Children:

• Explain whether enrollment is limited to children. Research that limits enrollment to children is generally not appropriate unless (i) the condition or disease is limited to children or (ii) the research seeks to obtain information on a test article or procedure that previously had been studied only in adults.

Members of minority groups:

• Explain whether the research holds out the prospect of benefit to individual subjects or the groups to which they belong, and
•  How non-English speaking participants will be consented.

STEVENS’ employees or students:

• Explain how they will be protected from coercion and undue influence, and
• What alternatives to participation exist, if any.

Excluding women and certain other types of participants
Explain whether it is justified by:

• Physiology, e.g. treatment for prostate cancer;
• Cultural prohibitions, e.g. one-to-one interviews of women in a situation where that might be construed as morally unacceptable;
• Childbearing potential, when women are not able to use reliable birth control methods for religious or other reasons and might have to be excluded from early Phase I studies of toxic chemical agents;
• Other reasons to be considered by the IRB.

Recruitment material to submit for IRB review

• Audio and video tape:  The IRB may review and approve the working prior to taping in order to preclude re-taping due to inappropriate working, with review of final broadcast-ready tape under an expedited review
• Printed advertisement:  the IRB will review the final copy to evaluate content and visual effect of materials
• Telephone:  the IRB will review the phone scripts to determine whether the information collected constitutes the minimum necessary to establish basic eligibility for the specific study.  Sample phone scripts are provided on the OSP webpages
• Internet and web postings:  the IRB will review the final draft to evaluate working and visual effects, except that if the electronic system precludes the additional of descriptive information, no review is necessary if it only lists basic information already approved in the IRB protocol such as title; purpose of research; protocol summary; basic eligibility criteria; research site location, contact information and required CPHS Review Statement

Not allowed

• Payment from research participants
•  “Cold-calling” of potential research participants (i.e., unrelated party initiating telephone contact based on knowledge of confidential information), unless the following preferred methods are unavailable and good reason exists:
• Patients of a particular clinic, physician or other caregiver only after the patient’s physician or caregiver has previously notified the potential research participant (or parent or legal representative) and obtained approval for such contact.
• Members of a program based in the community, workplace, school, trade or union only after a program representative has previously notified the potential research participant (or parent or legal representative) and obtained approval for such contact.
• Exculpatory language through which the participant or participant’s LAR is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator , the sponsor, the institution or its agents from liability for negligence.

Advertisements: Appropriate Language for Recruitment Material Advertisements

Payment to participants
When proposing payment, there must be justification to:

• Substantiate that proposed payments are reasonable and commensurate with the expected contributions of the subject;
• State the terms of the subject participation agreement and the amount of payment in the informed consent form; and
• Substantiate that subject payments are fair and appropriate, and that they do not constitute (or appear to constitute) undue pressure on the subject to volunteer for the research study.

Behavioral and social sciences research often involves surveys, observational studies, personal interviews, or experimental designs involving exposure to some type of stimulus or intervention. This guidance discusses when exemption and expedited review are appropriate for this type of research.

Social and Psychological Harms
When evaluating behavioral and social science research, the IRB carefully considers the following criteria when evaluating the research to determine the probability of risk of harm to subjects:

• The IRB considers the potential for participants to experience stress, anxiety, guilt, or trauma that can result in genuine psychological harm
• The IRB also considers the risks of criminal or civil liability or other risks that can result in serious social harms, such as damage to financial standing, employability, insurability, or reputation; stigmatization; and damage to social or family relationships.
• If information is being collected on living individuals other than the primary “target” subjects, the IRB considers the risk of harm to those “non-target” individuals, as well

To mitigate such risks, the IRB reviews the proposal for appropriate preventive protections and debriefings, adequate disclosure of risks in the informed consent information, and mechanisms to protect the confidentiality and privacy of persons participating in or affected by the research.

Research Involving Deception or Withholding of Information
When reviewing research involving incomplete disclosure or outright deception, the IRB applies both common sense and sensitivity to the review. Where deception is involved, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects shall be debriefed. Debriefing may be inappropriate, for example, when the debriefing itself would present an unreasonable risk of harm without a corresponding benefit.  The IRB will also make sure that the proposed subject population is suitable.  

Deception is only permitted where the IRB documents that an alteration of the usual informed consent requirements is justified under the criteria present in the Common Rule.  Specifically, the IRB must find and document that all four of the following criteria have been satisfied:

• The research presents no more than minimal risk to subjects
• The alteration shall not adversely affect the rights and welfare of the subjects
• The research could not practicably be carried out without the alteration
• Where appropriate, the subjects shall be provided with additional pertinent information after participation.

In making the determination to approve the use of deception under an alteration of informed consent, the IRB considers each criterion in turn, and documents specifically (in the minutes of its meeting and in the protocol file) how the proposed research satisfies that criterion.  (Note: The regulations make no provision for the use of deception in research that poses greater than minimal risks to subjects.)

The following is offered as guidance when contemplating the use of Stevens’ employees or laboratory personnel as subjects in Stevens’ human research projects:

• Whenever employees or laboratory personnel participate as subjects in a formally approved research project, they must render the same written informed consent as any other participant in the study.
• Principal Investigators and Project Director should understand that, by virtue of their dependent positions, employees or laboratory personnel represent a vulnerable population with regard to acting as research subjects. The directors should be sensitive to the need to avoid even subtle coercion and to ensure that all personnel who participate in even minimal risk research activities do so entirely voluntarily.
• In general, studies involving any type of intervention (e.g. the ingestion or injection of a substance, or venipuncture, solely for the sake of the study) should be considered research, subject to the need for written and signed informed consent.  The Investigator is urged to contact the CPHS coordinator at 201.216.5280 for guidance in questionable cases.
• In principle, the CPHS feels that if compensation is allowed, it should go to all subjects; however, compensation of individuals who are full-time members of the academic staff or regular exempt staff may not be allowed.
• As mentioned above, if doubt exists as to the appropriateness of having employees or laboratory personnel participate in even minimal risk activities the Investigator is urged to contact the CPHS coordinator for guidance.

Pregnant women or fetuses may be involved in research if all of the following conditions are met:

1. Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
2. The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;
3. Any risk is the least possible for achieving the objectives of the research;
4. If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of subpart A of this part;
5. If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this part, except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
6. Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
7. For children as defined in Sec 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part;
8. No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
9. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
10. Individuals engaged in the research will have no part in determining the viability of a neonate.

All investigators and research personnel listed on a human subjects’ application submitted to the Committee for the Protection of Human Subjects (CPHS) are required to complete a training course prior to protocol approval.

Why?

This requirement was first mandated by the National Institutes of Health in 2000 for individuals considered to be "key personnel" on research studies involving human subjects.  Stevens, in its written agreement with the federal government, has indicated that it has elected to apply the same standards and requirements to all human subjects’ research regardless of the source of support. Because of this agreement and our commitment to ethical research, the education requirement is extended to the following individuals:

Who?

• Principal Investigator(s) on all projects that include research involving human subjects
• All individuals responsible for the design or conduct human subjects research
• Those individuals identified as key personnel of consortium participants or alternate performance sites if they are participating in research that involves human subjects
• Those serving as voting members of the CPHS

Investigators who conduct human subjects’ research that is exempt from full CPHS review and approval must also comply with the education requirement; this became an NIH requirement in 2005 and Stevens feels it is an appropriate requirement regardless of the source, or presence, of funding. (The six exempt categories are defined in 45 CFR Part 46.101(b). Exempt protocols must still be submitted to the CPHS Expedited Review Committee for administrative review.)

Failure to assure the education component of our assurance is considered a circumstance of noncompliance, and has the potential to negatively affect funding opportunities for Stevens’ faculty, staff, and students. It is the PI’s responsibility to ensure that all individuals engaged in research have been appropriately trained.

What?

Two options are available to fulfill this requirement:

1. (Recommended): The web-based Course in the Protection of Human Research Subjects through the Collaborative Institutional Training Initiative (CITI). CPHS recommends this option as its primary one because CPHS personnel are able to access individual transcripts and verify training, making this the most convenient option for the PI and all associated personnel.
2. The CPHS will also accept NIH Human Subject Research training certificates.

How?

1. CITI training: To begin the online course, visit the CITI website and select “Register for the Course”. Select Stevens Institute of Technology as your institution, and a username and password. There are four options for human subject research training based on your scientific disciplinary focus, the level of student or faculty member, and the focus of your research:

Group 1: Human Subject Research-Biomedical and Physical Science Research Investigators and Graduate Students

Group 2: Human Subject Research-Social and Behavioral Research Investigators and Graduate Students

Group 3: Human Subject Research-SIT IRB Members and Staff

Group 4: Human Subject Research-Undergraduate Students

2. NIH training: This course is online. CPHS personnel CANNOT access the transcripts for this course; a copy of the certificate must be submitted to the CPHS Coordinator prior to final approval.

When?

The CPHS reviews documentation for the education requirement prior to the initial approval of a CPHS application, and when a revision is requested to add additional personnel. A refresher course is required every three years.

The CITI program provides a shorter version of the original training, listed as "Refresher Course." This will meet the training requirements for research personnel who have completed the original training course.

Stevens extends this training requirement to all research, regardless of funding source. For more information contact the CPHS office at 201.216.5280 or visit http://grants.nih.gov/grants/policy/hs_educ_faq.htm.

References:
Stevens Federal Wide Assurance number is 00014433 (available to Stevens personnel upon request)
Stevens IRB Number is 00005952
Expiration date is 5.30.2017