a human subject as an experimental subject is not the same as the definition of research involving human subjects. Section 980 of Reference (g) is not applicable to exempt research involving human subjects.

b.  When the research meets the Glossary definition of research involving a human being as an experimental subject, informed consent must be obtained in advance from the experimental subject or the subject’s legal representative consistent with part 219 of Reference (c) if the subject cannot consent. If consent is to be obtained from the experimental subject’s legal representative, the research must intend to benefit the individual subject. The determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB consistent with part 219 of Reference (c).

c.  The requirement of paragraph 9.b. of this section may be waived by the ASD(R&E) if all the following conditions are met:

(1)  The research is necessary to advance the development of a medical product for the Military Services.

(2)  The research may directly benefit the individual experimental subject.

(3)  The research is conducted in compliance with all other applicable laws and regulations.

d.  The ASD(R&E) may delegate the waiver authority described in paragraph 9.c. to the Heads of the OSD and DoD Components if they have appropriate policies and procedures in their management plans. This authority is further delegable only to a DoD Component official who is a Presidential Appointee with Senate Confirmation.

10.  PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED

a.  DoD-Supported Research Involving Human Subjects. All non-exempt research involving human subjects shall, at a minimum, meet the requirement of section 219.116(a)(6) of Reference (c). The Common Rule does not require payment or reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries.

b.  DoD-Conducted Research Involving Human Subjects. The DoD Components shall establish procedures to protect human subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in DoD-conducted non-exempt research involving human subjects that involves more than minimal risk. Such procedures may consist of utilizing the Secretarial Designee program as described by section 108.4(i) of Reference (c) during the period of the human subject’s involvement in the research, which may be extended further upon the approval of the USD(P&R). DoD Components may supplement this Secretarial Designee procedure with additional procedures consistent with applicable authority. This requirement does not apply when the Department of Defense is supporting the research but is not engaged in the non-exempt research involving human subjects (i.e., when the non-exempt research involving human subjects is performed solely by non-DoD institutions).

c.  DoD Collaborative Research Involving Human Subjects

(1)  When collaborating with a non-DoD institution, the DoD Components shall establish procedures comparable to those required by paragraph 10.b. of this section to protect human subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation



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