prisoner. This approved change to a research protocol does not require ASD(R&E) approval.

c.  Treatment of Detainees

(1)  Research involving a detainee, as defined in DoD Directive 2310.01E (Reference (p)), as a human subject is prohibited.

(2)  The prohibition in paragraph c.(1) of this section does not apply to activities covered by investigational new drug or investigational device provisions of Reference (d) when for the purpose of diagnosis or treatment of a medical condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the detainees’ informed consent when the medical products are subject to Reference (d) as investigational new drugs or investigational medical devices, and only when the same product would be offered to members of the U.S. Military Services in the same location for the same medical condition and only when consistent with established medical practice involving investigational drugs and devices. Such permitted treatment involving detainees as subjects shall comply with all sections of this Instruction, including paragraphs 6.a., b., and d. of this section, as applicable.

d.  Children as Subjects

(1)  Research involving human subjects conducted or supported by the Department of Defense that recruits children to be subjects must meet the additional relevant protections of subpart D of Reference (h), unless modified by this Instruction. If the minor is a pregnant woman, then paragraph 7.a. of this section also applies. If the minor is a prisoner, paragraph 7.b. of this section also applies.

(2)  The footnote in section 219.101(i) of Reference (c), prohibiting specific exemptions described in section 219.101(b) from applying to children, is also applicable to DoD-conducted or -supported research involving human subjects unless otherwise clarified in this Instruction.

e.  DoD Personnel as Subjects

(1)  Military Personnel as Subjects

(a)  Service members shall follow their command policies regarding the requirement to obtain command permission to participate in research involving human subjects while on-duty. Additionally a Service member’s ability to perform his or her military duties may be affected by participating during off-duty time (i.e., on leave or during non-duty hours). Therefore, Service members shall follow their Component and command’s policies for approving off-duty employment or activities. The IRBs of DoD institutions or HRPOs may require Principal Investigators to confirm that a Service member’s commander supports the member’s participation in DoD-supported research involving human subjects.

(b)  Superiors (e.g., military and civilian supervisors, unit officers, and noncommissioned officers (NCOs)) are prohibited from influencing the decisions of their subordinates (e.g., junior enlisted personnel and



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