Covert Human Subject Testing Alert
Letter to Dr. Ellis, OPRR, NIH
from Kathy Kasten
Letter to Dr. Ellis
Department of Defense policy enclosure
Dr. Gary B. Ellis
Office for Protection from Research Risks
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
MSC7507
Rockville, MD 20892-7507Fax: 301-402-2071
Dear Dr. Ellis:You had asked me to keep you apprised of any covert research activity. In light of that request, please read the enclosed Department of Defense policy #1520.
First, am I to understand that Department of Defense can by pass all Federal regulations governing human subject protection? Does the Congress know this? If the Department of Defense has entered into various "agreements with the Secretary of Health and Human Services", please advise whether this includes "use of human subjects for testing of chemical or biological agents?"
With reference to paragraph 1520: Will the individual human subjects in the target area (civilian or military) be provided Informed Consent Forms?
Paragraph 1520 (b) (1): Will the "local civilian officials" in the target area inform their taxpaying contituents of the tests, provide ICFS, and provide the list of Department of Defense contractors participating in the tests? How will the local Institutional Review Boards be informed of the targeted areas? What will be the mechanism utilized by the local IRBs to provide informed consent?
I am particularly concerned with the following questions: Will an individual be able to refuse to participate? How will they be accomodated?
Was the nullifying of the Nuremberg Code to set the stage for wholesale testing of civilians/military personnel at the expense of the United States taxpayers? Or, is the Defense Intelligence Agency receiving "private" funds from drug tafficking (as suggested by a New Times article which quotes Ron Liston's "business" partner - Dec. 12, 1996 editition?)
I hope the above questions give you pause to think.
Kathy Kasten1093 Broxton #607
Los Angeles, CA 90024cc:
Dr. Charles English, DOD, Office of the Director for Environmental & Life Sciences, Pentagon, Room 3D129, Washington, DC 20301-3080; Fax:703-693-7042
Dr. Stuart Nightingale, Assoc. Commissioner for Health Affairs, FDA, Parkawn Bldg., Room 1495, Mail Stop HFY-1, 5600 Fishers Lane, Rockville, MD 20857, FAX: 301-443-1300
Enclosure
#1520. Use of human subjects for testing of chemical or biological agents by Department of Defense; accounting to Congressional committees with respect to experiments and studies; notification of local civilian officials
(a) Not later than thirty days after final approval within the Department of Defense of plans of any experiment or study to be conducted by the Department of Defense, whether directly or under contract, involving the use of human subjects for the testing of chemical or biological agents, the Secretary of Defense shall supply the Committees on Armed Services of the Senate and Hosue of REpresentiatives with a full accounting of such plans for such experiment or study, and such experiment or study may then be conducted only after the expiration of the thirty-day period beginning on the date such accounting is received by such committees.
(b) (1) The Secretary of Defense may not conduct any test or experiment involving the use of any chemical or biological agent on civilian populations unless local civilian officials in the area in which the test or experiment is to be conducted are notified in advance of such test or the thirty-day period beginning on the date of such notificiation.
(b) (2) Paragraph (1) shall apply to tests and experiments conducted by Department of Defense personnel and tests and experiments conducted on behalf of the Department of Defense by contractors.