General FAQs
1. What is the definition of DoD-affiliated personnel?
DoD-affiliated personnel are defined as: Service members, Reserve Service members, National Guard members, DoD civilians, and DoD contractors. To further define Service members, they are individuals appointed, enlisted, or inducted for military service under the authority of the DoD. The Military Services are the Army; the Navy, including the Coast Guard under circumstances involving the declaration of war; the Air Force; the Marine Corps; and the Reserve Components. Members of the Reserve Components are included when in a duty status.
2. Are there any requirements when recruiting DoD-affiliated personnel as research subjects?
DoDI 3216.02, specifies DoD requirements when there is planned enrollment of DoD-affiliated personnel for a human research activity conducted or supported by the DoD. Requirements include that there must be Command approval (§3.9.f(2)) for the recruitment and if the research involves any risks to the DoD-affiliated personnel’s fitness for duty, the informed consent document must inform DoD-affiliated personnel about these potential risks and that they should seek command or Component guidance before participating (§3.9.f.1)). For a complete list of requirements, consult DoDI 3216.02.
3. Can military or civilian supervisors, officers, or others in the chain of command be present with their subordinates if there is a recruitment session or briefing for a human subjects research activity?
No. Military and civilian supervisors, officers, and others in the chain of command must not be present in any human subjects’ research participant recruitment session or during the consent process of DoD-affiliated personnel. This process is in place to minimize the ability of senior personnel from influencing junior personnel to participate in research.
Military and civilian supervisors, officers, and others in the chain of command may participate in a separate recruitment session for their own participation in the research, if applicable.
4. What is exempt HSR? Can investigators make this determinations for their own projects? Are exempt HSR activities exempt from all requirements and oversight?
Exempt HSR is HSR that meets specific federal criteria in 32 CFR Part 219, falling into one of the eight categories of Exempt research listed at 32 CFR 219.104. Exempt HSR must be initially determined as exempt by an IRB, its designee, or designated DoD HRPP personnel, and then is exempt from further review.
Exempt HSR is exempt from the requirements of 32 CFR 219, but is still subject to applicable provisions of DoDI 3216.02 to include the special protections for DoD-affiliated personnel in research referenced in question 2 of this section.
5. What is a DoD Assurance?
A written document stating an institution will comply with 32 CFR Part 219 (the Common Rule), and DoD and DoD Component policies. A DoD Assurance is required for DoD institutions that will be conducting non-exempt HSR.
A Federal-wide Assurance (FWA) is issued by the Department of Health and Human Services (DHHS) when research will be conducted or supported by DHHS.