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DOD Directive Permitting Experiments on Troops

 
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PostPosted: Sat Jun 23, 2007 10:32 pm    Post subject: DOD Directive Permitting Experiments on Troops Reply with quote

Experimenting on U.S. military personnel without informed consent is legal...under certain circumstances. This is just one Department of Defense document delineating those circumstances. I have cut and pasted the contents of DODD 3216.2 into this message string. The relevant paragraph is subheading 4.2.2. I've highlighted 4.2.2 in blue.

The former DOD official whose signature is on this document dated March 25, 2002 is former Deputy Secretary of Defense, Paul Wolfowitz.

Think about it.

Sincerely,
Gary Matsumoto




Department of Defense
DIRECTIVE


[b]NUMBER 3216.2
March 25, 2002
Certified Current as of December 1, 2003

DDR&E


SUBJECT: Protection of Human Subjects and Adherence to Ethical
Standards in DoD-Supported 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, Code of 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 welfare of 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.

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, as defined 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.

3. DEFINITIONS

Terms used in this Directive are as defined in enclosure 2.

4. POLICY

It is the policy of the Department of Defense that:

4.1. Protection of Human Subjects in Research. The rights and welfare of human subjects in research supported or conducted by the DoD Components shall be protected. This protection encompasses basic respect for persons, beneficence, and justice in the selection of subjects.

4.2. Informed Consent. In general, as required by reference (b), no DoD Component may conduct or use appropriated funds to support research involving a human being as an experimental subject without the prior informed consent of the subject.

DODD 3216.2, March 25, 2002

4.2.1. In the case of research intended to be beneficial to the subject, if the subject lacks capacity, due to age, condition, or other reason, to make a decision regarding consent to participate in the research, prior consent may be provided by a legal representative of the subject. In any such case, the determination that research is intended to be beneficial to the subject must be made by an Institutional Review Board (IRB) under reference (c).

4.2.2.Consistent with 10 U.S.C. 980(b) (reference (b)), the requirement for prior informed consent under paragraph 4.2. or subparagraph 4.2.1. may be waived by the Head of a DoD Component with respect to a specific research project to advance the development of a medical product necessary to the Armed Forces if the research project may directly benefit the subject and is carried out in accordance with all other applicable laws and regulations, including 21 CFR 50.24 (reference (j)).

4.3. Applicability of Federal Policy for Protection of Human Subjects in Research

4.3.1. The Department of Defense has joined with other Federal Agencies to adopt the "Common Rule" Federal policy for protection of human subjects in research. Reference (c) is the Department of Defense's implementation of the Common Rule. All DoD-supported and -conducted research shall comply with reference (c) and this Directive.

4.3.2. The IRBs of the DoD Components established under reference (c) shall consist of members who are either Federal employees, individuals covered under the Inter-governmental Personnel Act (IPA), or consultants consistent with the requirements established by 5 U.S.C. 3109 (reference (e)).

4.3.3. All human subject research supported or conducted by the Department of Defense shall be conducted under an assurance of compliance acceptable to the funding Agency. Research performed at DoD facilities and funded by the Department of Defense shall have a DoD assurance of compliance. The DoD Components conducting or supporting research must ensure that the investigators are familiar with the Nuremberg Code, the Belmont Report, 32 CFR Part 219 (reference (c)), this Directive, and any related requirements.

4.4. Additional Protections for Certain Categories of Research. In addition to the requirements of reference (c), the following requirements apply to research involving certain subjects or purposes.

4.4.1. Research supported or conducted by the Department of Defense that affects vulnerable classes of subjects shall meet the additional protections of 45 CFR DODD 3216.2, March 25, 2002

Part 46, Subparts B, C, and D (reference (f)) (e.g., fetuses, pregnant women, human in vitro fertilization, prisoners, or children). For purposes of this paragraph, actions authorizing or requiring any action by an official of the Department of Health and Human Services (HHS) with respect to any requirements of reference (f) shall be under the authority of the Director, Defense Research and Engineering.

4.4.2. The involvement of prisoners of war as human subjects of research is prohibited.

4.4.3. For research involving more than minimal risk (as defined in 32 CFR 219.102(i), reference (c)) to subjects, an independent medical monitor shall be appointed by name. Medical monitors shall be physicians, dentists, psychologists, nurses, or other healthcare providers capable of overseeing the progress of research protocols, especially issues of individual subject/patient management and safety. Medical monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient
advocate.

4.4.3.1. Depending on the nature of the study, the medic
al monitor may be assigned to assess one or more of the following phases of a research project: subject recruitment, subject enrollment, data collection, or data storage and analysis.

4.4.3.2. At the discretion of the IRB, the medical monitor may be
assigned to discuss research progress with the principal investigator, interview subjects, consult on individual cases, or evaluate adverse event reports. Medical monitors shall promptly report discrepancies or problems to the IRB. They shall have the authority to stop a research study in progress, remove individual subjects from a study, and take whatever steps are necessary to protect the safety and well-being of research subjects until the IRB can assess the medical monitor's report.

4.4.4. For research involving more than minimal risk and also involving military personnel, unit officers and noncommissioned officers (NCOs) shall not influence the decisions of their subordinates to participate or not to participate as research subjects. Unit officers and senior NCOs in the chain of command shall not be present at the time of research subject solicitation and consent during any research recruitment sessions in which members of units under their command are afforded the opportunity to participate as research subjects. When applicable, officers and NCOs so
excluded shall be afforded the opportunity to participate as research subjects in a separate recruitment session. During recruitment briefings to a unit where a percentage of the unit is being recruited to participate as a group, an ombudsman not connected in any way with the proposed research or the unit shall be present to monitor that the

DODD 3216.2, March 25, 2002

voluntary nature of individual participants is adequately stressed and that the information provided about the research is adequate and accurate.

4.4.5. Research involving use of human subjects for testing of chemical or biological agents is generally prohibited by 50 U.S.C. 1520a (reference (g)), subject to possible exceptions for research for prophylactic, protective, or other peaceful purposes. Any such research shall comply with reference (g).

4.5. Education and Training on Protection of Human Subjects in Research. Awareness of human subjects protection requirements shall be established for all DoD personnel involved in the conduct, review, or approval of research covered by this Directive.

4.5.1. Awareness activities shall be commensurate with the duties and responsibilities of the participants in the process of protection of human subjects of research, and compatible with Office of Human Research Protections (OHRP) policies.

4.5.2. Research ethics training shall be incorporated into the continuing education program at all DoD Component activities that conduct research involving human subjects.

4.6. Inclusion of Women and Minorities in Clinical Research Projects. The selection of subjects reflecting gender and minority participation as appropriate shall comply with section 252 of Pub. L. 103-160 (reference (h)). The Head of the DoD Component concerned may exercise the waiver authority under this law.

4.7. Fetal Tissue Research. Fetal tissue research supported or conducted by the Department of Defense shall comply with 42 U.S.C. 289g - 289g-2 (reference (i)).

4.8. Research Misconduct. All DoD Components shall establish procedures to monitor and review the ethical conduct of research. The DoD Components that conduct or support research shall ensure that data and data collection are conducted in an ethical manner. In cases in which data are not collected in an appropriate manner, the DoD Component shall determine if the misconduct was intentional or reckless; was an isolated event or part of a pattern; had significant impact on the research record; or had significant impact on other researchers or institutions. The DoD Component shall initiate and carry through on any actions that are necessary to ensure resolution of misconduct findings. All findings of serious research misconduct under this section shall be reported to the Director, Defense Research and Engineering.

4.9. Relationship to Other Requirements. Some activities subject to this Directive may also be subject to regulations of other Federal Agencies, organizations,

DODD 3216.2, March 25, 2002

and non-U.S. entities. Examples include: Food and Drug Administration policies regarding investigational drugs, vaccines, biological products, or devices; multi-agency research; and international research. Activities subject to this Directive and one or more of these other requirements shall comply with all applicable requirements (e.g., references (c) (32 CFR 219.101(g) and (h)), (j), (k), and (l)).

4.10. Non-compliance. Issues related to non-compliance with this Directive by any DoD Component, subordinate, or supported activity shall be referred initially to the next higher management echelon to take deliberate action to resolve. All findings of serious non-compliance under this section shall be reported to the Director, Defense Research and Engineering.

5. RESPONSIBILITIES

5.1. The Director, Defense Research and Engineering, under the Under Secretary of Defense (Acquisition, Technology, and Logistics):

5.1.1. Shall be the single point of contact within the Department of Defense for all matters relating to the Department of Defense's compliance with the "Common Rule" and act as the principal DoD liaison with Agencies outside the Department of Defense on matters pertaining to protection of human subjects in research.

5.1.2. May initiate updates to reference (c) and issue any DoD Instructions or other guidance necessary to implement this Directive. With respect to matters affecting medical research, this shall be done in coordination with the Assistant Secretary of Defense (Health Affairs) (ASD(HA)).

5.1.3. Shall establish a committee to coordinate DoD Component activities in the protection of human subjects. The committee shall be composed of representatives from the DoD Components' human subject protection offices.

5.1.4. Shall exercise the authorities of the Secretary of Defense under reference (c), except for matters not delegable, reserved, or covered by another specific delegation.

5.1.5. Shall establish procedures and standards, consistent with the Federal Policy on Research Misconduct (reference (m)), for the prevention of research misconduct in the Department of Defense.

DODD 3216.2, March 25, 2002

5.1.6. May grant exceptions to policy under this Directive if justified by special circumstances and consistent with law. Records shall be maintained on exceptions granted under this Directive.

5.2. The Assistant Secretary of Defense for Health Affairs, under the Under Secretary of Defense for Personnel and Readiness shall:

5.2.1. Advise the Director, Defense Research and Engineering on matters related to the involvement of human subjects in research, especially, regarding medical safety, ethics, and standards of professional care and conduct.

5.2.2. Serve as the DoD representative on matters relating to implementation of Food and Drug Administration regulatory requirements (references (j) and (k)).

5.3. The Heads of the DoD Components shall:

5.3.1. Develop, issue, and monitor implementing policies to ensure
compliance with this Directive and with any implementing Instructions issued under the authority of this Directive. In research undertakings in which more than one DoD Component is involved, the Heads of the Components shall determine and jointly assign executive responsibility for compliance.

5.3.2. Maintain adequate documentation of DoD-supported or -conducted research involving human subjects and establish procedures for supporting DoD reporting requirements.

5.3.3. Delegate authorities and responsibilities under this Directive to levels of command or authority appropriate to ensure compliance. This shall include procedures for the investigation and resolution of allegations of non-compliance, and may include procedures for headquarters-level administrative review of research. A DoD Component may delegate headquarters-level research review responsibility to another DoD Component for purposes of efficiency and consolidation of functional
offices.

5.3.4. With respect to research for which primary involvement is from the Department of Defense, establish the required administrative procedures to protect human subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in a research project involving more than minimal risk. For this purpose the determination of primary involvement shall be based on
consideration of the DoD portion of the total involvement (i.e., funding, personnel, facilities, and all other resources) in the research.

DODD 3216.2, March 25, 2002

6. EFFECTIVE DATE

This Directive is effective immediately.
Enclosures - 2
E1. References, continued
E2. Definitions
DODD 3216.2, March 25, 2002

E1. ENCLOSURE 1

REFERENCES, continued

(e) Section 3109 of title 5, United States Code, "Employment of Experts and Consultants, Temporary or Intermittent"
(f) Title 45, Code of Federal Regulations, Part 46, "Protection of Human Subjects," Subparts B, C, and D
(g) Section 1520a of title 50, Unites States Code, "War and National Defense"
(h) Section 2358 note of title 10, United States Code, "National Defense Authorization Act for Fiscal Year 1994," (Public Law 103-160, Sec. 252)
(i) Sections 289g - 289g-2 of title 42, United States Code, "Public Health and Welfare"
(j) Title 21, Code of Federal Regulations, Subchapters A, D, F, and H, "Food and Drug Administration"
(k) Memorandum of Understanding between the Food and Drug Administration and the Department of Defense, "Concerning Investigational Use of Drugs, Antibiotics, Biologicals, and Medical Devices by the Department of Defense," May 1, 1987
(l) DoD Directive 6000.8, "Funding and Administration of Clinical Investigation Program," November 3, 1999
(m) Federal Policy on Research Misconduct, Office of Science and Technology Policy, 65 Federal Register 76260-76264 (December 6, 2000)

DODD 3216.2, March 25, 2002

ENCLOSURE 1

E2. ENCLOSURE 2

DEFINITIONS

E2.1.1. Common Rule. The regulation adopted by multiple Federal Agencies for the protection of human subjects in research. The Department of Defense's implementation of the Common Rule is at 32 CFR 219, "Protection of Human Subjects" (reference (c)).

E2.1.2. Research. Any systematic investigation, including research, development, testing, and evaluation (RDT&E), designed to develop or contribute to generalizable knowledge.

E2.1.3. Research Involving a Human Being as an Experimental Subject. An activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction (32 CFR 219.102(f), reference (c)). Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject's environment, the withholding of an intervention that would have been undertaken if not for the research purpose. This does not include:

E2.1.3.1. Activities carried out for purposes of diagnosis, treatment, or prevention of injury and disease in members of the Armed Forces and other mission essential personnel under Force Health Protection programs of the Department of Defense.

E2.1.3.2. Authorized health and medical activities as part of the reasonable practice of medicine or other health professions.

E2.1.3.3. Monitoring for compliance of individuals and organizations with requirements applicable to military, civilian, or contractor personnel or to organizational units. This includes such activities as drug testing, occupational health and safety monitoring, and security clearance reviews.

E2.1.3.4. Activities exempt under 32 CFR Part 219 (reference (c)).

E2.1.4. Support. Unless otherwise clarified in a specific paragraph of this Directive, this term generally means the provision of funding, personnel, facilities, and all other resources.

DODD 3216.2, March 25, 2002


ENCLOSURE 2
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PostPosted: Wed Jul 11, 2007 2:46 am    Post subject: what about?? Reply with quote

Gary,
do have any info on policy prior to 2002 as to how Dod C.T.A.'ss. Or this could be collectively the same document, with new language added here and there to fit the current times. That's usually how government operates.
_________________
GWI, non-deployed, 100%, former WRAMC staff on first Gulf War Center, ill from adjuvant induced autoimmune disease.
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Location: Dayton, Ohio

PostPosted: Wed Jul 11, 2007 12:56 pm    Post subject: DoD inserts foot... Reply with quote

Like most things, the DoD understands their own writing differently than the way they write them.

Such as this statement in red for informed consent. Even if we are given the choice, how many of us have the "capacity" for the "other reason" to make the decision? My case being that I haven't enough knowledge "capacity" about vaccine development and medical science to make the decision.

4.2.1. In the case of research intended to be beneficial to the subject, if the subject lacks capacity, due to age, condition, or other reason, to make a decision regarding consent to participate in the research, prior consent may be provided by a legal representative of the subject. In any such case, the determination that research is intended to be beneficial to the subject must be made by an Institutional Review Board (IRB) under reference (c).

And this statement in red. Case being, they didn't know how it was going to benefit anyone...period. Plus from other readings, they have never even tested it enough or found enough threat over any other type of warfare to make it "necessary" or "beneficial".

4.2.2.Consistent with 10 U.S.C. 980(b) (reference (b)), the requirement for prior informed consent under paragraph 4.2. or subparagraph 4.2.1. may be waived by the Head of a DoD Component with respect to a specific research project to advance the development of a medical product necessary to the Armed Forces if the research project may directly benefit the subject and is carried out in accordance with all other applicable laws and regulations, including 21 CFR 50.24 (reference (j)).

Hope I made sense, I saw the tid-bit and wanted to get something in before going to work. Just my personal feeling onthe matter.

Sincerely,
Anthony
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PostPosted: Thu Jul 12, 2007 6:15 pm    Post subject: 1999 language vs. 2007 language Reply with quote

Hey Gary,
I just happened to find this 1999 Clinton policy on informed consent. Look at the difference in language between the current and this one. If I am reading this right, informed consent used to be waived by the President, with Dod providing evidence as to why it should be waived.

NOW a Dod head can waive informed consent.
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PostPosted: Thu Jul 12, 2007 6:18 pm    Post subject: 1999 language vs. 2007 language Reply with quote

THE WHITE HOUSE

Office of the Press Secretary
________________________________________________________________________
For Immediate Release September 30, 1999


EXECUTIVE ORDER

- - - - - - -

IMPROVING HEALTH PROTECTION OF MILITARY
PERSONNEL PARTICIPATING IN PARTICULAR MILITARY OPERATIONS


By the authority vested in me as President by the Constitution and
the laws of the United States of America, including section 1107 of
title 10, United States Code, and in order to provide the best health
protection to military personnel participating in particular military
operations, it is hereby ordered as follows:

Section 1. Policy. Military personnel deployed in particular
military operations could potentially be exposed to a range of chemical,
biological, and radiological weapons as well as diseases endemic to an
area of operations. It is the policy of the United States Government to
provide our military personnel with safe and effective vaccines,
antidotes, and treatments that will negate or minimize the effects of
these health threats.

Sec. 2. Administration of Investigational New Drugs to Members of
the Armed Forces.

(a) The Secretary of Defense (Secretary) shall collect intelligence
on potential health threats that might be encountered in an area of
operations. The Secretary shall work together with the Secretary of
Health and Human Services to ensure appropriate countermeasures are
developed. When the Secretary considers an investigational new drug or
a drug unapproved for its intended use (investigational drug) to
represent the most appropriate countermeasure, it shall be studied
through scientifically based research and development protocols to
determine whether it is safe and effective for its intended use.

(b) It is the expectation that the United States Government will
administer products approved for their intended use by the Food and Drug
Administration (FDA). However, in the event that the Secretary
considers a product to represent the most appropriate countermeasure for
diseases endemic to the area of operations or to protect against
possible chemical, biological, or radiological weapons, but the product
has not yet been approved by the FDA for its intended use, the product
may, under certain circumstances and strict controls, be administered to
provide potential protection for the health and well-being of deployed
military personnel in order to ensure the success of the military
operation. The provisions of 21 CFR Part 312 contain the FDA
requirements for investigational new drugs.

Sec. 3. Informed Consent Requirements and Waiver Provisions.

(a) Before administering an investigational drug to members of the
Armed Forces, the Department of Defense (DoD) must obtain informed
consent from each individual unless the Secretary can justify to the
President a need for a waiver of informed consent in accordance with 10
U.S.C. 1107(f). Waivers of informed consent will be granted only when
absolutely necessary.


(b) In accordance with 10 U.S.C. 1107(f), the President may waive the
informed consent requirement for the administration of an
investigational drug to a member of the Armed Forces in connection with
the member's participation in a particular military operation, upon a
written determination by the President that obtaining consent:

(1) is not feasible;

(2) is contrary to the best interests of the member; or

(3) is not in the interests of national security.

(c) In making a determination to waive the informed consent
requirement on a ground described in subsection (b)(1) or (b)(2) of this
section, the President is required by law to apply the standards and
criteria set forth in the relevant FDA regulations, 21 CFR 50.23(d). In
determining a waiver based on subsection (b)(3) of this section, the
President will also consider the standards and criteria of the relevant
FDA regulations.

(d) The Secretary may request that the President waive the informed
consent requirement with respect to the administration of an
investigational drug. The Secretary may not delegate the authority to
make this waiver request. At a minimum, the waiver request shall
contain:

(1) A full description of the threat, including the potential
for exposure. If the threat is a chemical, biological, or
radiological weapon, the waiver request shall contain an
analysis of the probability the weapon will be used, the
method or methods of delivery, and the likely magnitude of its
affect on an exposed individual.

(2) Documentation that the Secretary has complied with 21 CFR
50.23(d). This documentation shall include:

(A) A statement that certifies and a written
justification that documents that each of the criteria
and standards set forth in 21 CFR 50.23(d) has been met;
or

(B) If the Secretary finds it highly impracticable to
certify that the criteria and standards set forth in 21
CFR 50.23(d) have been fully met because doing so would
significantly impair the Secretary's ability to carry out
the particular military mission, a written justification
that documents which criteria and standards have or have
not been met, explains the reasons for failing to meet
any of the criteria and standards, and provides
additional justification why a waiver should be granted
solely in the interests of national security.

(3) Any additional information pertinent to the Secretary's
determination, including the minutes of the Institutional
Review Board's (IRB) deliberations and the IRB members'
voting record.

(e) The Secretary shall develop the waiver request in consultation
with the FDA.

(f) The Secretary shall submit the waiver request to the President
and provide a copy to the Commissioner of the FDA (Commissioner).

(g) The Commissioner shall expeditiously review the waiver request
and certify to the Assistant to the President for National Security
Affairs (APNSA) and the Assistant to the President for Science and
Technology (APST) whether the standards and criteria of the relevant FDA
regulations have been adequately addressed and whether the
investigational new drug protocol may proceed subject to a decision by
the President on the informed consent waiver request. FDA shall base
its decision on, and the certification shall include an analysis
describing, the extent and strength of the evidence on the safety and
effectiveness of the investigational new drug in relation to the medical
risk that could be encountered during the military operation.

(h) The APNSA and APST will prepare a joint advisory opinion as to
whether the waiver of informed consent should be granted and will
forward it, along with the waiver request and the FDA certification to
the President.

(i) The President will approve or deny the waiver request and will
provide written notification of the decision to the Secretary and the
Commissioner.

Sec. 4. Required Action After Waiver is Issued.

(a) Following a Presidential waiver under 10 U.S.C. 1107(f), the DoD
offices responsible for implementing the waiver, DoD's Office of the
Inspector General, and the FDA, consistent with its regulatory role,
will conduct an ongoing review and monitoring to assess adherence to the
standards and criteria under 21 CFR 50.23(d) and this order. The
responsible DoD offices shall also adhere to any periodic reporting
requirements specified by the President at the time of the waiver
approval.

The Secretary shall submit the findings to the President and provide a
copy to the Commissioner.

(b) The Secretary shall, as soon as practicable, make the
congressional notifications required by 10 U.S.C. 1107(f)(2)(B).

(c) The Secretary shall, as soon as practicable and consistent with
classification requirements, issue a public notice in the Federal
Register describing each waiver of informed consent determination and a
summary of the most updated scientific information on the products used,
as well as other information the President determines is appropriate.

(d) The waiver will expire at the end of 1 year (or an alternative
time period not to exceed 1 year, specified by the President at the time
of approval), or when the Secretary informs the President that the
particular military operation creating the need for the use of the
investigational drug has ended, whichever is earlier. The President may
revoke the waiver based on changed circumstances or for any other
reason. If the Secretary seeks to renew a waiver prior to its
expiration, the Secretary must submit to the President an updated
request, specifically identifying any new information available relevant
to the standards and criteria under 21 CFR 50.23(d). To request to
renew a waiver, the Secretary must satisfy the criteria for a waiver as
described in section 3 of this order.

(e) The Secretary shall notify the President and the Commissioner if
the threat countered by the investigational drug changes significantly
or if significant new information on the investigational drug is
received.

Sec. 5. Training for Military Personnel. (a) The DoD shall provide
ongoing training and health risk communication on the requirements of
using an investigational drug in support of a military operation to all
military personnel, including those in leadership positions, during
chemical and biological warfare defense training and other training, as
appropriate. This ongoing training and health risk communication shall
include general information about 10 U.S.C. 1107 and 21 CFR 50.23(d).

(b) If the President grants a waiver under 10 U.S.C. 1107(f), the DoD
shall provide training to all military personnel conducting the waiver
protocol and health risk communication to all military personnel
receiving the specific investigational drug to be administered prior to
its use.

(c) The Secretary shall submit the training and health risk
communication plans as part of the investigational new drug protocol
submission to the FDA and the reviewing IRB. Training and health risk
communication shall include at a minimum:

(1) The basis for any determination by the President that
informed consent is not or may not be feasible;

(2) The means for tracking use and adverse effects of the
investigational drug;

(3) The benefits and risks of using the investigational drug;
and

(4) A statement that the investigational drug is not approved
(or not approved for the intended use).

(d) The DoD shall keep operational commanders informed of the overall
requirements of successful protocol execution and their role, with the
support of medical personnel, in ensuring successful execution of the
protocol.

Sec. 6. Scope. (a) This order applies to the consideration and
Presidential approval of a waiver of informed consent under 10 U.S.C.
1107 and does not apply to other FDA regulations.

(b) This order is intended only to improve the internal management of
the Federal Government. Nothing contained in this order shall create
any right or benefit, substantive or procedural, enforceable by any
party against the United States, its agencies or instrumentalities, its
officers or employees, or any other person.


WILLIAM J. CLINTON


THE WHITE HOUSE,
September 30, 1999.
_________________
GWI, non-deployed, 100%, former WRAMC staff on first Gulf War Center, ill from adjuvant induced autoimmune disease.
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PostPosted: Sun Jul 15, 2007 1:15 pm    Post subject: Reply to ex-WRAMC Staff Reply with quote

Various federal regulations have permitted medical experimentation on U.S. military personnel without informed consent. I'm not sure how long these regulations have existed in writing, but at least one such policy (Food, Drug and Cosmetic Act) has existed on HHS (Department of Health and Human Services) books since the 1960s. This act contain language permitting clinical trials (on service personnel) without informed consent under certain circumstances.

DoD issued its own policy directives indicating it was permissible to use INDs (investigational new drugs), without specifying which INDS, during the first Gulf War. DoD documents show there were extensive discussions about the possibility of conducting clinical trials with experimental vaccines "in theater." Military scientists expressed concern about the Iraqis launching CW and BW attacks on coalition forces, and there was a consensus at the time both in Britain and the U.S. that the licensed vaccine didn't work very well (limited immunity, didn't defend against certain strains, required too many boosters). By coincidence, Fort Detrick had developed a new and theoretically improved anthrax vaccine in 1986-88, just prior to Desert Shield/Desert Storm. This new and improved vaccine contained two oil adjuvants: one was squalene; the other was its molecular cousin, squalane.

President Clinton issued Executive Order 13139 after I published an article in Vanity Fair, reporting preliminary data indicating troops at Dover AFB were injected with squalene-laced anthrax vaccine, starting in 1998. The two events may be purely coincidental, but I suspect not. When I phoned the National Institute of Health about squalene in anthrax vaccine prior to the article's publication, the NIH flak's first response wasn't: "that's crazy!" It was: "Are you working with a private investigator?"

NIH scientists had just published a paper (Banchereau J, Steinman R, Nature, v.392, 19 March 1998, pgs 245-252) hypothesizing that they could "tolerize" a subject to an immunogen by introducing nano-doses of said immunogen into the body through a special immune cell: "dendritic cells." The same year that NIH scientists published this paper, nano-doses of squalene in what appeared to be a two-fold serial dilution turned up on in the U.S. military's anthrax vaccine supply.

That exact same year, 1998, the NIH had formed a "Working Group" with DoD and the FDA to accelerate the development of rPA102 -- Fort Detrick's new recombinant anthrax vaccine that contained what? Squalene emulsions.

As DoD points out, one mustn't forget that squalene is also found in eggs, in mayonnaise (it's the eggs), all throughout the human body in much higher amounts, on fingertips, in plants, and in health food supplements.

And let us not forget.

From 1986 to at least 2002, it was added to various formulations of Fort Detrick's second generation, recombinant anthrax vaccine, otherwise known as rPA102. Fort Detrick scientists published that they had, at various times, added Ribi Adjuvant System (squalene emulsion), SAF-1 or Syntex Adjuvant Formula-1 (squalane emulsion) and MF-59 (squalene emulsion) to its second generation anthrax vaccine.

Interestingly, none of these publications contained any reference to the three decades-worth of pre-clinical data in animals showing that squalene, when injected into a variety of animals species, induces a variety of autoimmune diseases.

In all this time, DoD has never admitted to the media that it has been trying to develop a second generation anthrax vaccine for almost 27 years, and that for at least 12 of those years, some of the formulations contained squalene emulsions. To date, it has never admitted to the media that, even in this day and age, it is permissible to run classified clinical trials on U.S. service personnel without informed consent.

Sincerely,
Gary Matsumoto
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