Document Type: 
Document Number (FOIA) /ESDN (CREST): 
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Document Creation Date: 
November 4, 2016
Document Release Date: 
June 11, 2003
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Publication Date: 
March 17, 1994
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PDF icon CIA-RDP96-00789R002600160006-1.pdf85.62 KB
Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160006-1 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 ii, 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 th,Assistant Secretary of Defense jointly on June 10, 1993 by (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, cit is onducts nested that each Director indicate whether his Agency provides funding support for intramural or extramural research which involves human subject participation. If an Agency does conduct or 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 research activities. Human subjects is defined arli ingnt) individual about whom an investigator (professional 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. NO REFERRAL REQUIRED Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160006-1 Approved For Release 2003/09108 : CIA-RDP96-00789R002600160006-1 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. C7 J Je V. Osterman .. Edward D. Martin, M.D. Acting-Assistant-Secretary Director, Environmental of Defense (Health Affairs) and Life Sciences Approved For Release 2003/09/08 : CIA-RDP96-00789R002600160006-1