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.
This guidance addresses requirements for research supported by or otherwise subject to, the following federal departments and agencies:
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”)
- 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.
- Federal Drug Administration (FDA) Regulation, Title 21 CFR Part 50: “Protection of Human Subjects”, 1 April 2006.
- Federal Drug Administration (FDA) Regulation, Title 21 CFR Part 56: “Institutional Review Boards”, 1 April 2006.
- 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.
- Department of Defense (DoD) Directive 6200.2, “Use of Investigational New Drugs for Force Health Protection”, 24 November 2003.
- 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.
- Secretary of the Navy Instruction, SECNAVINST 5211.5E, “Department of the Navy (DoN) Privacy Program”, 28 December 2005.
- Federal Privacy Act (5 USC 301, 552a (1994)).
- 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.
- Department of Health and Human Services (DHHS), Office for Human Research Protections Guidance on Continuing Review, 15 January 2007
- Department of Defense (DoD) Directive 5230.9, “Clearance of DoD Information for Public Release”, 9 April 1996.
- Revised Policy for IRB Review of Human Subject Protocols at the National Institutes of Health (NIH), 1 May 2000.
Department of Defense1. Introduction
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 Corps of Engineers
- Coast Guard
- Coast Guard Academy
- Defense Advanced Research Projects Agency (DARPA)
- Defense Intelligence Agency
- Military Academy (West Point)
- Missile Defense Agency
- National Geospatial-Intelligence Agency
- National Guard
- National Security Agency
- National War College
- Naval Academy
- 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.
- 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
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
DOD Regulations and Guidance
- 32 CFR 219, Protection of Human Subjects
- DoD Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, November 8, 2011
- 10 USC 980, Limitations on the Use of Humans as Experimental Subjects
- Department of Defense Directive 3210.7, Research Integrity and Misconduct
- Department of Defense Directive 6200.2, Use of Investigational New Drugs in DOD Force Health Protection
Department of the NavyDepartment of the Navy
Human Research Protection Program
The DON supports research with human subjects conducted by DON commands; by extramural performers through contracts, grants, cooperative agreements, or other arrangement; and by collaborators with the DON. The DON implements human research protection requirements through Common Rule (32 CFR 219), Department of Defense (DoD) directives (DoDD 3216.2), and DON instructions (SECNAVINST 3900.39D).
The DoD and DON mandate additional requirements for research with human subjects. The key additional requirements and the corresponding specific citation are listed after "Applicability and Scope."
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]
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
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
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
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
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)