equivalent civilians) regarding participation as subjects in research involving human subjects covered by this Instruction.

(c)  Superiors of Service members (e.g., unit officers, senior NCOs, and equivalent civilians) in the chain of command shall not be present at any human subject recruitment sessions or during the consent process in which members of units under their command are afforded the opportunity to participate as human subjects. When applicable, the superiors so excluded shall be afforded the opportunity to participate as human subjects in a separate recruitment session.

(d)  For research involving Service members as human subjects that has been determined to be greater than minimal risk and when recruitment occurs in a group setting, the IRB shall appoint an ombudsman. The ombudsman shall not be associated in any way to the research and shall be present during the recruitment in order to monitor that the voluntary involvement or recruitment of the Service members is clearly and adequately stressed and that the information provided about the research is clear, adequate, and accurate. The ombudsman may also be the research monitor (see section 8 of this enclosure). For research involving Service members as human subjects, that has been determined to be NO greater than minimal risk and when recruitment occurs in a group setting, the IRB shall determine when it is appropriate to appoint an ombudsman for the purposes described in this paragraph. The decision to require the appointment of an ombudsman should be based in part on the human subject population, the consent process, and the recruitment strategy.

(2)  DoD Civilians as Subjects

(a)  DoD Civilians shall follow their organization’s policies regarding the requirement to obtain permission to participate in research involving human subjects.

(b)  Supervisors (e.g., military and civilian supervisors or anyone in the supervisory structure) are prohibited from influencing the decisions of their subordinates regarding participation as subjects in research involving human subjects covered by this Instruction.

(c)  Supervisors (e.g., military and civilian supervisors or anyone in the supervisory structure) shall not be present at any human subject recruitment sessions or during the consent process in which DoD civilians under their supervision are afforded the opportunity to participate as human subjects. When applicable, supervisors so excluded shall be afforded the opportunity to participate as human subjects in a separate recruitment session.

(d)  For research involving civilians as human subjects and when recruitment occurs in a group setting, the IRB shall discuss appointing an ombudsman for the purposes described in subparagraph e.(1)(d) of this section. The decision to require the appointment of an ombudsman should be based in part on the human subject population, the consent process, and the recruitment strategy.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement