Overview
Research supported by the Department of Defense (DoD), including the separate components, the Army, Navy, Air Force and Marine Corps, or recruitment of DoD personnel requires compliance with additional federal regulations, Directives and Instructions. This procedure applies to human subject research that is funded by any DOD component or that recruits participants from the DoD.
Definitions
DoD Addendum: An application to the Department of Defense attesting that the University of Pittsburgh will comply with all relevant federal regulations, DoD Instructions and Directives and other relevant documents regarding the protection of human subjects in research. The Addendum applies to research supported by the DoD, Air Force, Navy, and Marine Corps. The Army does not use the mechanism of an Addendum. Additional Army requirements are managed through the contracting process.
The University of Pittsburgh has a DoD Addendum in place for the Air Force and Navy. Copies of these documents are available on the HRPO website.
Continuing non-compliance: A pattern of noncompliance that suggests the likelihood that, without intervention, instances of noncompliance will recur. A repeated unwillingness to comply, or a persistent lack of knowledge of how to comply with the DoD Instructions 3216.02.
Minimal risk: When following Department of Defense regulations: The definition of minimal risk based on the phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in everyday life. For example the risks imposed in certain work environments (emergency responder, pilot soldier in a combat zone) or with certain medical conditions (frequent medical tests or constant pain).
Non compliance: Failure of a person, group, or institution to act in accordance with DoD Instruction 3216.02
Research Involving a Human Being as an Experimental Subject: 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 (32 CFR 219.103(f) reference (c)). Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose. Research involving a human being as an experimental subject is a subset of research involving human subjects. Further information surrounding this definition may be found at: http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf.
Educational Requirements
Initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support or manage human research supported by the DoD or its components. At the present time, the University of Pittsburgh IRB requires that individuals conducting human subjects research complete modules on Responsible Conduct of Research and Human Subjects Protection as described in Chapter 22. Individual DoD components may have stricter or specific educational requirements, and may require re-certifications more frequently than currently mandated by the University of Pittsburgh IRB. Researchers should contact their Program Officer at the DoD, or DoD component, to ensure adherence to any unique requirements. It is the Principal Investigator’s responsibility to ensure that research staff has completed all appropriate educational requirements as mandated by DoD policy. Please refer to the following link outlining the minimum educational requirements: http://www.onr.navy.mil/About-ONR/compliance-protections/Research-Protec...
Scientific Review
New research and substantive modifications to approved research must undergo scientific review prior to or at the time of IRB review. This requirement can be met by University departmental scientific review process.
Research Monitor
For studies involving greater than minimal risk, appointment of an independent research monitor is required. If appropriate, the IRB or organizational official can also require this for research involving no more than minimal risk.
- The Principal Investigator is responsible for providing the name, contact information and responsibilities of the monitor or to the IRB in Section 5.13 of the OSIRIS application.
- There may be more than one research monitor for a study depending on the skillset required by the protocol.
- The monitor may be an ombudsman or a member of the data safety monitoring board.
- The IRB must approve a written summary of the monitor’s duties, authorities, and responsibilities.
- The IRB or Institutional Official shall communicate with the research monitors to confirm their duties, authorities, and responsibilities.
- Depending on the nature of the study, the research monitor may be assigned to assess one or more of the following functions of the research project: observation of subject recruitment, enrollment, or the consent process, oversight of study interactions or interventions, data collection, or data storage and analysis, and review of monitoring plans and unanticipated problems involving risk to participants or others.
- The research monitor may discuss the research protocol with the investigators, interview subjects, and consult with others outside of the study about the research.
- The research monitor has the authority to stop a research study in progress, remove individuals from a study, and/or take any steps to protect the safety and well-being of subjects until the IRB can make an assessment.
- The research monitor has the responsibility to promptly report any discrepancies or problems to the IRB or designated official.
- The Heads of the OSD and DoD Components may waive the requirement to have a research monitor on a case by case basis when the inclusion of a research monitor is not necessary to provide additional protections for human subjects.
Consent Issues
Research-related Injury
The Department of Defense components may have stricter requirements regarding research-related injury than those outlined in the policies of the University of Pittsburgh and federal regulations. Investigators should work with their Program Officer within the DoD component to identify such requirements. Additional language regarding specific requirements by the DoD should be incorporated into the informed consent document as appropriate.
Waiver of Consent
If the research subject of a study funded by the DoD or its components meets the definition of “experimental subject” then a waiver of consent [including an exception from informed consent in emergency medicine research] by the IRB is prohibited unless a waiver is obtained from the Assistant Director of Defense for Research and Engineering. However, if the research subject does not meet the definition of an “experimental subject,” then the IRB may waive the consent process. Waivers are prohibited for classified research.
Consent from Legally Authorized Representative
Research involving consent by a legally authorized representative is only permissible if the research is intended to be beneficial to individual subjects. The determination that the research is intended to be beneficial to the experimental subject must be made by the IRB. The University of Pittsburgh has additional requirements for those who are decisionally impaired as outlined in Chapter 14. As a protocol at the University would need to meet both sets of requirements, the more restrictive policy would apply.
Archiving of Records
The Department of Defense may require submission of records to the Department of Defense for archiving.
Studies Involving Department of Defense Personnel
Undue Influence
For research involving more than minimal risk and also involving military personnel, the following additional protections must be in place and articulated in the OSIRIS application to minimize undue influence:
- Officers cannot influence the decision of their subordinates to participate in the research.
- Officers and senior non-commissioned officers cannot be present at the time of recruitment into the research.
- Officers and senior non-commissioned officers must have a separate opportunity to participate in the research.
- When recruitment involves a percentage of a unit, an ombudsman, who is independent of both the proposed research as well as the unit must be present to monitor that the voluntary nature of the individual participants is adequately stressed and that the information provided about the research is adequate and correct.
Compensation
The following limitations on dual compensation for U.S. military personnel apply for DoD funded research:
- An individual may not receive pay from more than one position for more than 40 hours of work in one calendar week. This limitation on dual compensation includes temporary, part-time and intermittent appointments.
- Individuals may receive compensation for research activities if the research activities take place outside of scheduled work hours.
- Federal employees while on duty and non-Federal persons may be compensated for blood draws for research up to $50 for each blood draw.
- Non-Federal persons may be compensated for research participation other than blood draws in a reasonable amount approved by the IRB according to local prevailing rates and the nature of the research.
Vulnerable Populations
Research supported or conducted by the Department of Defense that affects vulnerable classes of subjects must meet the additional protections of 45 CFR Part 46, Subparts B, C, and D. Determinations authorizing or requiring any action by an official of DHHS is under the authority of the Director, Defense Research and Engineering.
Research with Minors
The exemption at 45 CFR 46.101 (b) (2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed (See 32 CFR 219.101.
Service Members and Their Status as Adults: For purposes of legal capacity to participate in DoD-conducted or supported research involving human subjects, all active duty Service members and all Reserve Component members in a Federal duty status are considered for the purpose of DoD Instruction 3216.02 to be adults. When Service members are under 18 years of age, students at Service Academies, or trainees, the IRB shall carefully consider the recruitment process and the necessity to include such members as human subjects.
Research with Prisoners
Captured or detained personnel: -The DOD Directive 3216.02 (section 4.4.2) prohibits research involving prisoners of war. This includes any person captured, detained, held, or otherwise under the control of DOD personnel (military and civilian or contractor employees). Such persons include enemy prisoners of war, civilian internees, detained persons, lawful and unlawful enemy combatants. Such persons do not include DOD personnel being held for law enforcement purposes.
This prohibition does not apply to research involving investigational drugs and devices when the same products would be offered to US military personnel in the same location for the same condition.
DOD funded research involving prisoners cannot be expedited.
In addition to the allowable categories of research on prisoners in 45 CFR Part 46, Subpart C, epidemiological research is allowable when:
- The research describes the prevalence or incidence of a disease by identifying all cases or studies the potential risk factor associations for a disease.
- The research presents no more than minimal risk.
- The research presents no more than an inconvenience to the participant.
- Prisoners are not a particular focus of the research.
If a participant becomes a prisoner, if the researcher asserts to the IRB that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, the IRB chair may determine that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, until the convened IRB can review this request to approve a change in the research protocol and until the organizational official and DoD component office review the IRB’s approval to change the research protocol.
Pregnant Women
For the purposes of applying 45 CFR Part 46, Subpart B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge.”
The applicability of Subpart B is limited to research involving pregnant women in research that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.
Fetal Research
Fetal research funded by the DOD must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g. Please refer to Chapter 14 of the IRB Policies and Procedures Manual, Considerations for Special Subject Populations, Research Involving Pregnant Women, Neonates, and Fetuses.
Additional DoD Review Requirements
Formal Agreements
When conducting multi-site research, investigators should contact the University of Pittsburgh Office of Research to ensure that a formal agreement between organizations is implemented. The purpose of the agreement is to specify the roles and responsibilities of each party.
Surveys
Surveys involving Department of Defense personnel must be submitted, reviewed, and approved by the Department of Defense after the research protocol is reviewed and approved by the IRB. Any requested DoD changes must subsequently be submitted to the IRB for review.
International Research
When DoD-sponsored research involves human subjects who are not U.S. citizens or DoD personnel and the research is conducted outside the United States, and its territories, the Principal Investigator must obtain permission from the host country. The laws, customs, regulations and practices of the host country and those required by the University of Pittsburgh IRB will be followed. An ethics review by the host country, or local DoD IRB with host country representation is required. Evidence of permission to conduct the research in the host country by certification or local ethics review must be submitted to the University of Pittsburgh IRB prior to initiation of the project.
Additional Reporting Requirements for Investigators and the IRB
Investigators
Investigators conducting DOD funded research must promptly report (within 30 days)to the DoD research protection officer:
- When Significant changes to the research protocol are approved by the IRB
- The results of the IRB continuing review
- Change of reviewing IRB
The IRB
The IRB must promptly report (within 30 days) to the DoD research protection officer when they are notified by any Federal department, agency or national organization that any part of the human research protection program is under for cause investigation of a research protocol involving a DoD support.
References
32 CFR 219
10 USC 980
DoD Directive 3216.2
SECNAVINST 3900.39D
OPNAVINST 5300.8B
DoD Dual Compensation Act, 24 U.S.C 301