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To: wakingtime
http://www.gulfwarvets.com/ubb/Forum1/HTML/002352.html
11 posted on 02/08/2003 3:25:31 PM PST by wakingtime (I can't get NO respect!)
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To: wakingtime
"The Dragon Goes North"

Chemical and Biological Warfare Testing in Alaska

Richard A. Fineberg

1972

Foreword by the Honorable Mike Gravel, US Senator

Preface - xii

I Introduction - 3

The Dragon

Games

Perspectives

2 The United States and CBW: Policy "Roots" - 8

Chemistry and Biology in War

The Geneva Protocol

No First Use

Retreat from Policy

The Cold War Buildup

Dugway, 1968: The Turning Point

3 The President's Statement - 24

The Chemical Arsenal: No First Use

The Geneva Protocol: A Redefinition

The Biological Arsenal

Biological Research: The Best Offense Is a Good Defense

Toxins

Destruction of Germ Warfare Stockpiles

Conclusion

4 Mismanagement, Deception and Death - 39

The Gas That Sailed

Death in Maryland

Earthquakes in Colorado

What Shall We Do with a Concrete Coffin?

Nowhere to Go

5 Journey to the South - 63

Introduction to Chemical Warfare

Germ Warfare

Nerve Gas: The Trump Card

An Exercise in Futility

Stability Operations

Drive Safely: Good Friends Are Hard to Find

The Dragon

6 Dragon on the Last Frontier - 85

VX Lake

Testing Tularemia in Alaska

The Almost Test


7 CBW and Public Health in Alaska: An Appraisal - 109

Death at Fort Greely

Paralysis in Fairbanks

Epidemiology: The Need for Further Research

Biological Warfare Testing: A Special Horror

8 CBW, Secrecy and National Security - 127

Secrecy and Public Policy

National Security: The Enemy Threat

The Lesson of VX Lake

Appendixes

A 135; B 137; C 148; D 164; E 169

Notes

Index

§ § §

The basic problem is, we have a system, then, with a lot of people who don't know what it means to be accountable to the public. The Congress is the enemy, just as the press is the enemy. And the public is seen by members of the Executive in general as the great beast, treacherous, ignorant, irrational, not to be respected, either individually or in the mass. - Daniel Ellsberg

…the only effective restraint upon the executive policy and power in the areas of national defense and international affairs may lie in an enlightened citizenry – in an informed and critical public opinion which alone here can protect the values of democratic government… - Potter Stewart, Associate Justice of the Supreme Court, concurring in the Court’s decision to allow publication of the Pentagon Papers

http://arcticcircle.uconn.edu/SEEJ/NMD/alaska/greely/fineberg/index.htm


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GOT POWERPOINT? http://mrmc-www.army.mil/docs/rcq/HSRRBOffSite02/DECOT.ppt (MICROSOFT POWERPOINT) "- ... Development of guidelines for approving classified research. Potential policy changes resulting from Project SHAD. New DoD Directive 3216.2. ..."

mrmc-www.army.mil/docs/rcq/HSRRBOffSite02/DECOT.ppt


JB: Here is part of the content on the slides. Not all of it converts to text in this format, but this will give you an idea what's on it...

Frank


~~~~~~~~~~~~~~

Website: http://www.dtic.mil/biosys

DDR&E Updates to Human Subject Research Policy HSRRB Off-Site³Human Subjects Protection Program Best Practices² Frederick, MDSeptember 5, 2002

Patty Decot Assistant Director for Regulatory Affairs Office of the Deputy Under Secretary of Defense for Science and Technology Office of the Director, Defense Research & Engineering Human Use Policy Oversight Groups Kitchen Cabinet Members Regulatory Affairs-Human UseLooking Forward--Near Term Human Subjects Issues: DEPSECDEF approval of revised DoDD 3216.2 Full use of revisions to 10 USC 980 to enhance medical trauma product development Development of guidelines for approving classified research Potential policy changes resulting from Project SHAD New DoD Directive 3216.2 Updates the Directive to reflect 32 CFR 219 (³The Common Rule²) New title: ³Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research² Located at the DoD web site for directives: www.dtic/mil/whs/directives/corres/pdf/d32162_032505/d32162p.pdf Outline of Changes to DoDD 3216.2 Enhanced Protection of Research Subjects Better Definition of Medical Monitor New Policies Training Enhanced Protection of Subjects Minimizing command influence on subject recruitment: Individual recruitment -- No unit officers or senior NCOs in chain of command present Unit recruitment -- Ombudsman with no connection to the unit or to the research must be present Subjects are protect from expenses not otherwise provided or reimbursed if primary support of research is from the DoD


Medical Monitor Better definition of the medical monitor Appointed if more than minimal risk Defines who may function as such Shall be independent of the research team May be assigned responsibilities by the IRB New Policies Modifications to 10 USC 980 All human subjects research conducted or supported by DoD shall have an assurance of compliance that is acceptable to the funding agency DoD Supported International Research: Shall comply with 32 CFR 219 Shall comply with all applicable requirements Research misconduct requires all components to establish procedures to monitor and review the ethical conduct of research Based on recent OSTP federal policy DoD Instruction has been drafted by DUSD(Lab & BS) Training All DoD personnel involved in human subject research are required to be aware of policies Awareness of requirements for protection of subjects commensurate with involvement and compatible with OHRP policies Research ethics training incorporated in continuing education program Human Use Regulatory Affairs Advisor Focus on Training & Education for decision makers above IRB (e.g. COs and OSD Senior Staff ) Developed as a research effort in Advanced Distributed Learning Research product deliverable 1Q/FY03 Classified Research OSTP requested comment from Departments and Agencies on Clinton Memorandum of March 27, 1997 (Federal Register, Volume 62, Number 92) Secretary Cohen endorsed Clinton policy in December 13, 1999 memorandum Policy is still in effect but was not incorporated into the revised DoDD
3216.2 Policy currently undergoing revision HSRS Work Focus on consistent interpretation of Common Rule and resulting guidance Determination of Annual Review date Non-Biomedical Issues Public Use Data Files Confidentiality Decision Tree to help determine if work is human subjects research Financial Conflict of Interest Policy governing classified research Conference to simplify and unify policies and interpretations from federal offices Issues in DoD Human Subject Research Policy Adverse publicity Ethics, Conflict of Interest, Fraud, Genetics research HHS Office of Human Research Protection - Federal Wide Assurance IRB accreditation Education requirements IRB members ³Second Level² Staff Scientists/Investigators Approving Officials Multi-Service Collaboration Regional -- WRAMC, NNMC, MCMC, & USU and BAMC & WHMC Research programs at sites that are geographically separated HIPAA The Way Ahead How do we ensure: Personnel at all levels are keeping current ­ the HQ staff, Institutional officials, IRB members, and PIs Personnel at all levels are continually striving for improved competence and knowledge Points of Contact Director, BioSystems Dr. Robert Foster
703-588-7420, DSN 425-7420 Robert.Foster@osd.mil

Assistant Director for Regulatory Affairs Mrs. Patty Decot
703-588-7402, DSN 425-7402 Patty.Decot@osd.mil http://mrmc-www.army.mil/docs/rcq/HSRRBOffSite02/DECOT.ppt
12 posted on 02/08/2003 3:35:50 PM PST by wakingtime (You've GOT to question a "Government that would GAS ITS OWN PEOPLE!")
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