USAF SG DELEGATION OF AUTHORITY FOR THE USE OF MEDICAL

File: aacxf_09.txt
Page: 09
Total Pages: 13

c. Inclusion of human subjects, whether as the direct object of research
or as the indirect object of research involving more than minimal risk in the
development and testing of military weapon systems, vehicles, aircraft, and other
materiel. The determination of whether a research protocol involves more than
minimal risk shall he made by review committees established in accordance with
section F., below. Nothing in this Directive is intended to supersede require-
ments for health hazard or other safety reviews required by other DoD issuances
or other DoD Component regulations.

3. Its provisions do not apply to epidemiological surveys that are of no
more than minimal risk as set forth in the human protection regulations issued
by the Department of Health and Human Services (45 CFR 46, reference (a)).

4. Nothing in this Directive is intended to limit the authority of a health
care practitioner to provide emergency medical care under applicable law of the
jurisdiction in which the care is provided or of commanders in the discharge of
assigned duties or responsibilities.

C. DEFINITIONS

Terms used in this Directive are as defined in reference (a), except for the
following:

1. Human Subject. A living individual about whom an investigator conducting
research obtains data through interaction which the individual, including both
physical procedures and manipulations of the subject or the subject's environment.
The term does not include military or civilian personnel who are qualified to test
by assignment to duties that call specifically for such qualifications such as
test pilots and test engineers.

2. Non-U.S. Citizens. Foreign nationals, excluding, for the purposes of this
Directive, personnel on active duty.

1. Research. A systematic investigation as descried in paragraphs 8.2.a.,
h., and c., above, that is designed to develop or contribute to generalizable
knowledge. The term does not include individual or group training of military
personnel such as combat readiness, effectiveness, proficiency, or fitness
exercises.

D. POLICY

I. It is the policy of the Department of Defense that:

a. The fundamental rights and welfare of human subjects in research
funded by DoD Components shall he protected to the maximum extent possible.
This protection is meant to encompass basic respect for human dignity and to
protect subjects from actual harm. Responsibility for the protection of human
subjects is a command responsibility.
h. Except as provided elsewhere in this Directive, the human protection
regulations issued by the Department of Health and Human Services (reference
(a)) shall apply to research supported by the Department of Defense.