PROTECTION OF HUMAN SUBJECTS IN RESEARCH

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00792R000600180006-7
• Release Decision: RIFPUB
• Original Classification: U
• Document Page Count: 2
• Document Creation Date: November 4, 2016
• Document Release Date: August 25, 2003
• Sequence Number: 6
• Publication Date: February 17, 1994
• Content Type: MEMO

Approved For Release 2003/09/10 : CIA-RDP96-00792R000600180006-7
OFFICE OF THE SECRETARY OF DEFENSE
WASHINGTON, D.C. 20301
FEB 1 7 1994
MEMORANDUM TO DIRECTORS OF THE DEFENSE AGENCIES
SUBJECT: Protection of Human Subjects in Research
On August 11, 1991, the Federal Common Policy for the
Protection of Human Subjects in Research was adopted by the
Department of Defense (DOD) and published in Title 32, Code of
Federal Regulations, Part 219. Subsequently, Policy Guidance for
implementation of the Human Subjects Regulations was issued
jointly on June 10, 1993 by the Assistant Secretary of Defense
(Health Affairs) and the Office of the Director, Defense Research
and Engineering to the Assistant Secretaries of the Military
Departments having cognizance for research, development, testing,
and acquisition.
It has been brought to our attention that at least one Defense
Agency has recently initiated a-program in medical technology.
To ensure that all Department of Defense Agencies are in
compliance with current human use regulations, it is requested
that each Director indicate whether his Agency conducts or
provides funding support for intramural or extramural research
which involves human subject participation. If an Agency does
conductor support human subjects research the required
administrative package will be provided to ensure Agency
compliance with the above Federal Regulation. For clarity,
research is defined as a systematic investigation, including
research, development, testing and evaluation, designed to
develop or contribute to generalizable knowledge. Activities
which meet this definition constitute research for purposes of
this policy, whether or not they are conducted or supported under
a program which is considered research for other purposes. For
example, some demonstration and service programs may include
research activities. Human subjects is defined as a living
individual about whom an investigator (professional or student)
conducting research obtains data through intervention or
interaction with the individual, or obtains identifiable private
information regarding the individual used for research purposes.
Directors are requested to provide the status of Agency
participation in the conduct or support of intramural or
extramural human subject research by March 4, 1994 to
Director, Environmental and Life Sciences
Office of the Director, Defense Research and Engineering
Pentagon Room 3D129
Washington, D.C., 20301-3030
Negative responses are required.
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 Approved For Release 2003/09/10 : CIA-RDP96-00792R000600180006-7
My point of contact for this action is Captain John F.
Jemionek, MSC, USN, who may be contacted at (703) 697-1494. Your
assistance in ensuring total DoD compliance with Federal
Regulation in the area of human subject protection in research is
appreciated.
Edward D. Martin, M.D.
Acting Assistant Secretary
of Defense (Health Affairs)
MeNh V. Osterman
Director, Environmental
and Life Sciences
Approved For Release 2003/09/10 : CIA-RDP96-00792R000600180006-7