Thanks for the first link Ron. Follow this down to this exemptionfrom the protection of this directive at 2.3:
2.3. Does not apply to the use of investigational new drugs, biological products, or devices
for purposes of Force Health Protection. Such use is not research and is governed by DoD
Directive 6200.2 (reference (d)).
It then says to refer to DoD Directive 6200.2(reference (d)).
Then look at 3.4. under Particular Military Operations. of this directive
3.4. Particular Military Operations. A military operation or specific military
mission or function, which involves any chemical, biological, or radiological warfare
or endemic disease threats.
Then this exemption comes under:
21 CFR subpart I of part 312 and subpart G of part 601 (reference (c)) and I can't locate this on the Internet.
It is clear they deem to exclude curtain subjects from protection basedon needed science to protect our troops. The truth is though that Icame under attack after a false arrest and attack set up by police that fell apart and which I attempted to prove.
The drug testingwith massive doses of Seroquel are now killing soldiers coming homefrom war with PTSD. It doesn't sound like they actually have theirprotection in mind either. It seems more likely they don't want them ondisability for life even after the service they gave to theircountry.
links below: Peter Rosenholm
http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf
Department of Defense
DIRECTIVE
NUMBER 3216.02
March 25, 2002
Certified Current as of April 24, 2007
USD(AT&L)
SUBJECT: Protection of Human Subjects and Adherence to Ethical Standards in DoDSupported
Research
References: (a) DoD Directive 3216.2, "Protection of Human Subjects in DoD-Supported
Research," January 7, 1983 (hereby canceled)
(b) Section 980 of title 10, United States Code
(c) Title 32, Codeof Federal Regulations, Part 219, "Protection of Human
Subjects," current edition
(d) DoD Directive 6200.2, "Use of Investigational New Drugs for Force Health
Protection," August 1, 2000
(e) through (m), see enclosure 1
1. REISSUANCE AND PURPOSE
This Directive:
1.1. Reissues reference (a) to update policies for protecting the rights and welfareof
humans as subjects of study in Department of Defense (DoD)-supported research, development,
test and evaluation, and other related activities hereafter referred to as "research."
1.2. Implements 10 U.S.C. 980 (reference (b)).
1.3. Supports implementation of 32 CFR Part 219 (reference (c)), referred to as the
"Common Rule."
1.4. Establishes other DoD policies for the ethical conduct of research.
DoDD 3216.02, March 25, 2002
2
2. APPLICABILITY AND SCOPE
This Directive:
2.1. Applies to the Office of the Secretary of Defense, the Military Departments, the
Chairman of the Joint Chiefs of Staff, the Combatant Commands, the Office of the Inspector
General of the Department of Defense, the Defense Agencies, the DoD Field Activities and all
other organizational entities in the Department of Defense (hereafter referred to collectively as
"the DoD Components").
2.2. Applies to research involving human subjects, asdefined herein, conducted by a DoD
Component (i.e., intramural) and other research that is supported by a DoD Component (i.e.,
extramural) through a contract, grant, cooperative agreement, or other arrangement.
2.3. Does not apply to the use of investigational new drugs, biological products, or devices
for purposes of Force Health Protection. Such use is not research and is governed by DoD
Directive 6200.2 (reference (d)).
2.4. Does not apply to accepted medical practice, including the use of investigational
products in such practice, undertaken for purposes of treatment, not research. Such medical
practice is not research and is not subject to this Directive.
http://www.med.navy.mil/sites/nmrc/documents/DoD6200_2.pdf
Department of Defense
DIRECTIVE
NUMBER 6200.2
August 1, 2000
ASD(HA)
SUBJECT: Use of Investigational New Drugs for Force Health Protection
References: (a) Section 1107 of title 10,United States Code
(b) Executive Order 13139, "Improving Health Protection of Military
Personnel Participating in Particular Military Operations," September
30, 1999
(c) Title 21, Code of Federal Regulations, Parts 50, 56, 312, Subpart I of
Part 314, Subpart G of Part 601, current edition
(d) House Report No. 105-736, Conference Report to Accompany
Proposed Strom Thurmond National Defense Authorization Act for
Fiscal Year 1999, page 685
(e) through (f), see enclosure 1
1. PURPOSE
This Directive:
1.1. Establishes policy and assigns responsibility for compliance with references
(a) through (c) for the use of investigational new drugs for force health protection.
1.2. Designates the Secretary of the Army as the DoD Executive Agent for the
use of investigational new drugs for force health protection.
2. APPLICABILITY AND SCOPE
This Directive:
2.1. Applies to the Office of the Secretary of Defense, theMilitary Departments,
the Chairman of the Joint Chiefs of Staff, the Combatant Commands, the Office of the
1
Inspector General of the Department of Defense, the Defense Agencies, the DoD Field
Activities and all other organizational entities within the Department of Defense
(hereafter referred to collectively as "the DoD Components").
2.2. Applies to all uses of investigational new drugs by the Department of
Defense for force health protection.
2.3. Does not apply to actions by DoD healthcare providers that are within
standard medical practice in the United States and are not subject to FDA regulations
at reference (c).
3. DEFINITIONS
3.1. Force Health Protection. An organized program of healthcare preventive or
therapeutic treatment, or preparations for such treatment, designed to meet the actual,
anticipated, or potential needs of a group of military personnel in relation to military
missions.
3.2.Investigational New Drug (IND). A drug or biological product subject to the
FDA regulations at 21 CFR Part 312 (reference (c)), including:
3.2.1. A drug not approved or a biological product not licensed by the FDA.
3.2.2. A drug unapproved for its applied use.
3.3. Drug Unapproved for Its Applied Use. A drug or biological product
administered for a use not described in the labeling of the drug or biological product
approved by the FDA (referred to in subsection (g)(2) of reference (a)), and for which
FDA requirements of use authorization and prior informed consent (referred to in
subsections (d)(4) and (f)(1) of reference (a)) are applicable, but not including uses to
which those requirements are inapplicable based on standard medical practice in the
United States (referred to in reference (d)).
3.4. Particular Military Operations. A military operation or specific military
mission or function, which involves anychemical, biological, or radiological warfare
or endemic disease threats...........................
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