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Army Regulation 70-15
Research and Development
Use of Volunteers
as Subiects of
Research
Army review(s)
completed.
Headquarters
Department of the Army
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Approved For Release 2003/09/09 CIA-RDP96-00789ROO2100180001-9 -JUN 1990
PROCEDURES FOR USE OF HUMANS AS RESEARCH SUBJECTS
IN THE EXTRAMURAL RESEARCH PROGRAM
Purpose: This is to establish uniform procedures and respon-
sibility for review of the use of humans as research subjects,
negotiation of provisions, and administration of research projects
in the extramural program. Wherever the term "contractor" appears
it shall also mean grantee and other Government agency.
Ii. References
1. 45 CFR 46 HHS Regulation on Protection of Human Subjects;
2. 10 U.S.C. Section 980 Limitations on Use of Humans as
Experimental Subjects;
3. 21 CFR 312 Investigational Drugs and Vaccines;
4. 21 CFR 812 Investigational medical Devices;
5. 21 CFR 56.111(a)(3) Advertisement Guidelines for the
Recruiting of Research Subjects;
6. DOD Directive 6465.2 organs and Tissues Obtained from
Autopsy;
7. DOD Directive 3216.2 Protection of Human Subjects in
DOD-Supported Research;
8. Federal Acquisition Regulation (FAR) 52.228-7 Insurance
Liability to Third Persons and FAR 31-109 Advance Agreements; 1 1
9. USAMRDC Regulation 70-25 Use of Human Subjects in
Research, Development, Testing and Evaluation;
10. USAMRDC Broad Aqency Announcement (BAA);
11. Army Regulation 340-21 The Army Privacy Program; and
12. Federal Acquisition Regulations (FAR) Part 24 Protection
of Privacy and Freedom of Information, 52.224-1 Privacy Act
Notification, and 52.224-2 Privacy Act.
III. Objectives:
1. Safeguarding the rights and welfare of human subjects
participating in research and development supported by contracts,
grants and orders awarded by U.S. Army Medical Research and
SOP 8
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Development Command (USAMRDC) is of utmost concern to the Command,
and is primarily the responsibility of the contractor or recipient
who receives or is accountable to USAMRDC for the funds awarded for
the support of the project. However, the sensitivity of such
research necessitates that the Command exercise prudence in its
oversight responsibilities. The procedures employed shall be
flexible and tailored to the requirements of the specific acquisi-
tion.
2. It is the policy of USAMRDC that the Department of Health
and Human Services (HHS) Regulation on Protection of Human Sub-
jects, Food and Drug Administration Regulations on Investigational
Drugs and vaccines and Investigational Medical Devices, and
Advertisement Guidelines for the Recruiting of Research Subjects
shall be adhered to by USAMRDC contractors and recipients, with the
addition of the following specific DOD/USAMRDC requirements.
a. Informed consent must be obtained in advance from the
subject, or in the case of research intended to be beneficial to
the subject, the informed consent of the subject or a legal
representative of the subject must be obtained in advance.
b. Contractors and recipients shall provide all neces-
sary medical care to research subjects for injury or disease which
is the proximate result of participation in the research.
C. Anatomical Substances (organs, tissues, or tissue
fluids) obtained from autopsy shall not be used for research or
investigational purposes without the expressed consent of the next
of kin. It should be noted that a general autopsy consent may not,
in itself, be sufficient. If autopsy tissue is to be used, the
protocol should include a copy of the consent form used to obtain
the tissue.
d. Anatomical Substances (organs, tissues, or tissue'
fluids) obtained from a surgical procedure shall not be used for
research or investigational purposes without the expressed consent
of the patient or patient's legal representative. It should be
noted that a consent to perform surgery may not, in itself, be
sufficient. If excised tissue is to be used, the protocol should
include a copy of the consent form used to obtain the tissue.
e. Anatomical substances linked by identifiers to a
particular person and used for research shall be donated for the
purpose of research, and shall be lawfully acquired. Thedonor
shall be the person from whom the substance is removed or, in the
event of death or legal disability of the person from whom the
substance is removed, the next of kin or legal representative of
such person. Donation shall be made by written consent and the
donor shall relinquish all ownership and/or rights to the sub-
stance. If excised or autopsy tissue is to be used, the protocol
should include a copy of the consent form used to obtain the
tissue.-
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