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Improving the Presumptive Disability Decision-Making Process for Veterans Appendix L Additional Classification and Secrecy Information APPENDIX L-1 HISTORY OF RADIATION STUDIES CLASSIFICATION The following paragraphs are excerpted from the ACHRE Report, Chapter 13 (1995): The Manhattan Project’s “Security Manual” followed the Army rules, requiring classification of information as Confidential, and even at the higher level of Secret, in the absence of likely harm to national security (Manhattan Engineer District, 1945). Before the end of World War II, therefore, there was precedent for using the classification system to do more than protect national security. (p. 2) The era of atomic energy presented the government with unique questions of secrecy. The government built the atomic bomb behind an extraordinary shield of wartime secrecy. The very existence of the newly created communities surrounding AEC laboratories in Los Alamos, New Mexico; Hanford, Washington; and Oak Ridge, Tennessee; was a secret. Children at Oak Ridge schools did not use their full names, and houseguests were introduced as “Mr. Smith” (Warren, 1966). Following the Hiroshima bombing, the government faced the somewhat paradoxical task of protecting its single most important military secret while having to inform the public, if not the world, about both the hazards and peacetime spin-offs that the creation of the bomb had engendered—from radiation fallout and waste to nuclear power and radioisotopes for medical research and treatment. (p. 2) At the war’s end, a committee (known after its chair as the Tolman Committee) convened to determine what information from the Manhattan Project should be declassified. In its report, the Tolman Committee concluded that “in the interest of national welfare it might seem that nearly all information should be released at once” (Committee on Declassification to Major General L. R. Groves, 1945). But national welfare had to be considered in light of national security. Still, “it is not the conviction of the [Tolman] Committee that the concealment of scientific information can in any long term contribute to the national security of the United States” (Committee on Declassification to Major General L. R. Groves, 1945). The progress of science, the committee reasoned, depends on the free flow of information, and long-term national security depends on the progress of science.
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Improving the Presumptive Disability Decision-Making Process for Veterans In the short term, however, the security of the nation required some secrecy. Thus, the Tolman Committee concluded that secrecy could be justified for reasons of national security and then only if “there is a likelihood of war within the next five or ten years” (Committee on Declassification to Major General L. R. Groves, 1945). Applying this general philosophy to the question of secrecy in medical research, it recommended that “all reports on medical research and all health studies” be immediately declassified except for those reports that contained information independently classified in the interest of short-term national security (Committee on Declassification to Major General L. R. Groves, 1945). (p. 2) While the Tolman Committee report generally advocated openness, it also set the precedent for keeping declassification guides secret. The report recommended that “the whole of the Declassification Guide should not, however, be generally distributed since it gives an overall picture of the whole project and makes mention in certain instances of extremely secret matters. The portions of the Declassification Guide needed for the work of anyone concerned with declassification should be made available” (Committee on Declassification to Major General L. R. Groves, 1945). By following this recommendation, the AEC, and later the Department of Energy, would keep from the public the ever-accumulating rules governing weapons-related information. Indeed, the first three declassification guides covering information on nuclear weapons, published in 1946, 1948, and 1950, were declassified only in 1995 (Manhattan Engineer District, 1946; Atomic Energy Commission, 1948, 1950). (p. 2) In 1946 Congress enacted the Atomic Energy Act, which, in creating the AEC, expressly addressed the protection of atomic energy information. The act provided that all information related to atomic energy was to be considered as Restricted Data (RD) until the AEC reviewed it and decided that it should be unprotected (RD was, therefore, said to be “born secret”). The act prohibited the unauthorized disclosure of RD (making it a capital crime to do so in the course of espionage) and prohibited anyone from receiving access to it without first receiving a security clearance. At the same time, however, the act instructed the AEC not to protect information if the AEC did not consider its disclosure harmful to the national security. Thus, the statute defined RD to mean “all data concerning the manufacture or utilization of atomic weapons, the production of fissionable material, or the use of fissionable material in the production of power, but shall not include any data which the Commission from time to time determines may be published without adversely affecting the common defense and security” (Atomic Energy Act, 1954). (p. 2), [emphasis added] When it began operation in 1947, the AEC was heir to two traditions: one in which official secrets could extend beyond national security to matters of prestige and another in which the interest in promoting openness and limiting secrecy to matters of national security was recognized. In public, AEC biomedical officials and advisers advocated the latter policy. In secret they embraced the former and even expanded it to encompass “embarrassment.” Through as late as 1949, the declassification of reports on human experiments involved their review for public relations and legal liability implications. Documents revealing the dual tracks of public policy making and the secret review process did not become public until 1994. Important pieces of the story remain unclear, including the way in which AEC officials and advisers reconciled seemingly contrary principles. (p. 3)
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Improving the Presumptive Disability Decision-Making Process for Veterans … [W]hen Manhattan Project medical official Hymer Friedell recommended in late 1946 that one of the reports on the plutonium injection experiments be declassified, officials inside the new AEC reacted strongly. On March 19, 1947, AEC Medical Division chief Major B. M. Brundage countermanded the declassification decision, on grounds of “public relations.” The plutonium report produced the strongest reaction, but it was not the only report on human data at issue. Brundage’s March 19 memo also stated that further reports (“Studies of Human Exposure to Uranium Compounds” and “Uranium Excretion Studies”) should remain classified. On March 21, an AEC declassification officer confirmed the reclassification on the ground that “these documents may involve matters prejudicial to the best interests of the Atomic Energy Commission in that experiments with humans are involved.” The memo expressed hope that “a definite policy in this matter will be announced or explained in the near future” (Batson, 1947). (p. 3) In April 1947 that hope was partly fulfilled when Colonel O. G. Haywood of the Corps of Engineers wrote to H. A. Fidler, an AEC information officer, that “it is desired that no document be released which refers to experiments with humans and might have adverse effects on public opinion or result in legal suits. Documents covering such work should be classified as secret” (Haywood, 1947). (p. 3) References ACHRE (Advisory Committee on Human Radiation Experiments). 1995. Final report. Washington, DC: Government Printing Office. http://hss.energy.gov/healthsafety/ohre/roadmap/achre/report.html (accessed March 7, 2007). Atomic Energy Commission. 1948. Declassification guide. ACHRE No. DOE-050495-B. Atomic Energy Commission. 1950. Declassification guide for responsible reviewers. ACHRE No. DOE-052595-B. Batson, R. T. 1947. Reclassification of documents. ACHRE No. DOE-101394-A. Letter to Dr. A. H. Dowdy. Committee on Declassification to Major General L. R. Groves. 1945. Report of Committee on Declassification (Tolman Committee report). ACHRE No. DOE-120594-D. Haywood, O. G. 1947. Medical experiments on humans. ACHRE No. DOE-051094-A-62. Memo to H. A. Fidler. Manhattan Engineer District. 1945. Security manual. ACHRE No. DOE-050595-B. Manhattan Engineer District. 1946. Declassification guide for responsible reviewers. ACHRE No. DOE-050495-B. Warren, S. L. 1966. Transcript of audio recording. ACHRE No. UCLA-101794-A. Interviewed by A. Tusler. APPENDIX L-2 LEVELS OF CLASSIFICATION, FROM PIKE, 2002 Unclassified—Limited: “the distribution category applied to the a wide range of unclassified types of official information, which although not requiring protection as National Security Information, is limited to official use and not publicly releasable. Other similar markings, such as For Official Use Only (FOUO) and Limited Official Use are not used to identify classified in-
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Improving the Presumptive Disability Decision-Making Process for Veterans formation … six Distribution Statements designated A through F, were approved establishing categories of Unclassified/Limited Data” (Pike, 2002): Approved for Public Release: “available to the public, foreign nationals, companies, foreign governments, and may be exported without a license” Limited to Government Agencies: “covers weapons test and evaluation data, contractor performance evaluation records, foreign government data and proprietary information” Limited to Government Agencies and Their Contractors: involves “critical technologies which advance the state of the art in an area of significant or potentially significant military application” Limited to DoD and DoD Contractors Only: “designed to protect information on system or hardware in the development of concept stage, which must be protected to prevent premature dissemination” Distribution to DoD Components Only Further Dissemination Only as Directed: “normally imposed only on classified documents, but may be used on unclassified documents where specific authority exists” Information or material that requires additional protection against unauthorized disclosure in the interest of national security is classified in one of three designations namely: Top Secret, Secret or Confidential. Confidential (C) is applied to information or material the unauthorized disclosure of which reasonably could be expected to cause damage to the national security. Examples of damage include the compromise of information that indicates strength of ground, air, and naval forces in the United States and overseas areas; disclosure of technical information used for training, maintenance, and inspection of classified munitions of war; revelation of performance characteristics, test data, design and production data on munitions of war. Secret (S) is applied to information or material the unauthorized disclosure of which reasonably could be expected to cause serious damage to the national security. Examples of serious damage include disruption of foreign relations significantly affecting the national security; significant impairment of a program or policy directly related to the national security; revelation of significant military plans or intelligence operations; compromise of significant military plans or intelligence operations; and compromise of significant scientific or technological developments relating to national security. Top Secret (TS) is applied to information or material the unauthorized disclosure of which reasonably could be expected to cause exceptionally grave damage to the national security. Examples of exceptionally grave damage include armed hostilities against the United States or its allies; disruption of foreign relations vitally affecting the national securely; the compromise of vital national defense plans or complex cryptology and communications intelligence systems; the revelation of sensitive intelligence operations, and the disclosure of scientific or technological developments vital to national security. Special Access Program (SAP) is any program which imposes need-to-know or access controls beyond those normally required for access to Confidential, Secret, or Top Secret information. It is the policy of the Department of Defense to use security classification
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Improving the Presumptive Disability Decision-Making Process for Veterans categories to limit access to classified information on a need-to-know basis to personnel who have been determined to be trustworthy, and to apply the need-to-know principle in the regular system so that there will be no need to resort to formal Special Access Programs. Also, need-to-know control principles shall be applied within Special Access Programs. In this context Special Access Programs may be created or continued only on specific showing that normal management and safeguarding procedures are not sufficient to limit need-to-know or access, and the number of persons who need access will be reasonably small and commensurate with the objective of providing extra protection for the information involved. Each Special Access Program is assigned a classified code word, or an unclassified nickname, or both. Sensitive Compartmented Information (SCI) is information and material that requires special controls for restricted handling within compartmented intelligence systems and for which Code Word compartmentation is established. Special Activity is an activity, or functions in support of such activity, conducted in support of national foreign policy objectives abroad that is planned and executed so that the role of the U.S. Government is neither apparent nor acknowledged publicly; but that is not intended to influence U.S. political processes, public opinion, polices, or media and does not include diplomatic activities or the collection and production of intelligence or related support functions. References Pike, J. 2002. Security and classification. Gloucester, MA: Granite Island Group, Technical Surveillance Counter Measures. http://www.tscm.com/classification.html (accessed April 10, 2007). APPENDIX L-3 NUREMBERG CODE OF 1947 Trials of War Criminals before the Nuremberg Military Tribunals, 1949; Nuremberg Code, 1947; Office on NIH History, Office of Intramural Research: The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the natures, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests with each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
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Improving the Presumptive Disability Decision-Making Process for Veterans The experiment should be so designed and based on the results of animal experimentation and knowledge of the natural history of the disease or other problems under study that the anticipated results [will] justify the performance of the experiment. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted, where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians will also serve as subjects. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even the remote possibilities of injury, disability or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seems to him to be impossible. During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. References Nuremberg Code. 1947. In Doctors of infamy: The story of the Nazi medical crimes, A. Mitscherlich and F. Mielke. New York: Schuman. http://www.cirp.org/library/ethics/nuremberg/ (accessed April 25, 2007). Office on NIH History, Office of Intramural Research. Laws related to the protection of human subjects. http://www.history.nih.gov/laws%5Chtml%5Cnuremberg.htm (accessed April 25, 2007). Trials of war criminals before the Nuremberg military tribunals. 1949. Control Council Law 10(2):181-182. http://www.copernicusgroup.com/irbForms/NurembergCode.pdf (accessed March 7, 2007). APPENDIX L-4 EXCERPTS FROM TAYLOR AND JOHNSON, 1975 This report was the result of a request to the Inspector General and Auditor General of the Department of the Army (DoA) by the Secretary of the Army to research the use and treatment of human volunteers in chemical agent research. The request was prompted by congressional inquiries, during 1975 and 1976, by the Senate Select Committee on Intel-
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Improving the Presumptive Disability Decision-Making Process for Veterans ligence Activities and joint hearings by the Senate’s Labor and Public Welfare Committee and the Judiciary Committee, individual Members of Congress, private citizens, and the press regarding the use of human volunteers in testing of hallucinogenic substances in DoA chemical warfare research. Although the report focused largely on psychochemical testing programs and on testing programs from approximately 1950 to 1975, it also related certain specific aspects of the history of chemical warfare research in regards to treatment of human volunteers and general attitudes toward and compliance with the Nuremberg Codes of 1947. The major conclusion of these authors was that the secrecy, applied to the projects, to the overall research program, and even to the official guidelines governing use of human volunteers, left ample room for misinterpretation, lack of knowledge about, and outright disregard for established policies and guidelines. The June 1942 request for human volunteers to the Secretary of War, and its subsequent approval, gave authority to the War Department to use human volunteers in the World War II sulfur mustard and Lewisite testing programs. The approval of this request became the basis on which such authority was retained by the Army and the Chemical Warfare Service to use human volunteers in all other World War II and later testing programs up to the mid 1950s. In July 1950, research was placed under the control of the Army by the Organization of the Army Act. Despite the establishment in 1947 of the Nuremberg Codes regarding the appropriate use and treatment of human subjects in research, Taylor and Johnson reported that no documentation could be found about whether the Army was explicitly bound by the Codes. By 1952, the Armed Forces Medical Policy Council filed a request to use human subjects and suggested that the Nuremberg Codes be used as guidelines. The possible guidelines were discussed at a meeting at Edgewood Arsenal in March 1953. Recommendations were made at the conference that distinctions be made between hazardous and non-hazardous test situations so that non-hazardous procedures/tests would not require approval of the human-use research protocols. The examples given for non-hazardous situations were training exercises in which men, equipped with gas masks, went through gas chambers filled with high concentrations of sulfur mustard. A further proposal was that any human-use codes based on the Nuremberg Codes should only apply to biological warfare testing, not to chemical or radiological testing. This proposal was rejected. Formalized guidelines were finally issued in June 1953 in a Chief of Staff Memo (MM385). These guidelines represented an official adoption of the Nuremberg Codes (although somewhat modified) and were meant to apply to all types of chemical, radiological, and biological warfare testing. Further, they required all projects to be approved by the Secretary of the Army. However, no detailed descriptions of what types of experiments required this approval were included, and the report authors argue later that this was a “loophole” that permitted “selective compliance” with the guidelines. For example, in August 1953 seven research projects were sent for approval, one on vesicants and other agents, one on phosgene, and five on nerve agents. Not sent for approval was a research project labeled a “local field exercise” at Fort McClellan, Alabama (Operation TOP HAT). This operation involved use of Chemical Corps personnel in tests of decontamination methods for biological warfare agents, sulfur mustard, and nerve gases. These personnel were not informed and were not volunteers. The justification for the lack of a request for approval was that the project fell under the “line of duty” definition and was not subject to protocol approval.
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Improving the Presumptive Disability Decision-Making Process for Veterans Another example given by Taylor and Johnson pointed out that protocols were often submitted to test a class of drugs, rather than a specific drug at defined dosage levels. One project entitled, “Retention of Nerve Gas in the Human Respiratory Tract” was given only a cursory examination prior to approval, despite the fact that the specific nerve agents to be used were not listed in the proposal. By 1955, when research into psychochemicals began, approvals were still being given for general research types and not for specific protocols. In 1957, more potent nerve agents were being tested, but the protocols for this research were not sent for examination and approval on the justification that they were simply extensions of projects already approved years earlier. By 1959, Secretary of the Army Brucker gave blanket approval for all projects utilizing “non-lethal incapacitating agents,” and the period between 1959 and 1975 was typified by great inconsistency in policy and practices relating to research with human volunteers. The situation became so bad, and the outcry from Congress, the press, and the citizenry so intense, that all research with human volunteers was suspended in 1975 by Acting Secretary of the Army Norman Augustine. References Taylor, J. R., and W. N. Johnson. 1975. Research report concerning the use of volunteers in chemical agent research. DAIG-IN 21-75. Washington, DC: Department of the Army, Office of the Inspector General and Auditor General. APPENDIX L-5 EXCERPTS FROM IOM, 1993 The lack of exposure data for the WWII human subjects caused the committee to attempt to gather as much information as possible about the experimental protocols, the equipment used, and any injuries from official reports of the testing programs. The committee found that an atmosphere of lingering secrecy still existed in the Department of Defense regarding some of the testing programs. Reports of the specific experimental protocols were not always easy to obtain; in some cases, reports were not available or were obtained as the study was almost complete. Fortunately, enough information was gathered to allow reasonable estimates of the exposures to human subjects, who were repeatedly exposed to mustard agents and Lewisite in gas chamber tests or under so-called field conditions. (pp. vi-vii) As the full scope of the WWII testing protocols was revealed, compelling ethical questions emerged. At times, it seemed as if every new discovery only posed more questions. As the study progressed, the bits and pieces of information finally coalesced into a picture of abuse and neglect that was impossible for the committee to ignore. One of the first discoveries was that the end point of all the WWII mustard agent and Lewisite experiments was tissue injury—from mild skin burns to severe, and widespread, skin burns that took more than a month to heal. The chamber and field tests were actually called “manbreak” tests. (p. vii) Both veteran self-reports and official documents revealed that some subjects suffered damaging injuries to the lungs and upper respiratory system from inhalation of the agents. Committee analysis of expected gas mask efficiencies further showed that projected nor-
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Improving the Presumptive Disability Decision-Making Process for Veterans mal mask leakage under the hot, humid conditions of the gas chambers would have, in some cases, resulted in exposure levels as high as those reported on World War I battlefields. (p. vii) The first response of many of the committee members to these discoveries was to try to understand the actions of the investigators in historical context—it was a war and the experiments were conducted before the Nuremberg Code of 1947 established formal principles to govern the proper treatment of human subjects. However, examination of the treatment and care of WWII chemical warfare production workers, and the conduct of later military experiments with human subjects from 1950 to 1975, demonstrated a well-ingrained pattern of abuse and neglect. Although the human subjects were called “volunteers,” it was clear from the official reports that recruitment of the WWII human subjects, as well as many of those in later experiments, was accomplished through lies and half-truths. (p. vii) Most appalling was the fact that no formal long-term follow-up medical care or monitoring was provided for any of the WWII human subjects, other exposed military personnel, or chemical warfare production workers, despite knowledge available by 1933 that mustard agents and Lewisite could produce long-term debilitating health problems, particularly in those people suffering severe burns and inhalation injuries. There was not even adequate short-term follow-up of the human subjects by the Department of Defense. Subjects in the chamber tests were sworn to secrecy and simply released on leave at the conclusion of the experiments. Some of these men still had blisters or evidence of skin burns upon release, but were not given any instructions about how to obtain knowledgeable medical care if they had needed it. (p. vii) Although the experiments began in a wartime climate of urgency and secrecy, it was clearly a mistake in this case to continue the secrecy after the conclusion of the war. Follow-up of the exposed human subjects could have provided a wealth of information on the effects of these war gases and could have served as a basis for legitimate disability claims by injured subjects. By the end of the war, the use of nitrogen mustard as a chemotherapeutic agent (developed as part of the WWII testing program) clearly showed the serious health effects that the previous “volunteers” might be expected to experience. (p. viii) In the face of the abuses uncovered, the committee members nevertheless sought to maintain an appropriate balance of their scientific responsibilities in assessing the available literature and their ethical responsibilities as physicians and scientists. In this effort, the committee members were guided by their stated task and their own individual judgments of the scientific and historical information examined. Thus, the committee believes that the findings and recommendations contained in this report are entirely justified by the scientific, medical, and historical evidence examined. There are, however, specific statements the committee wishes to offer as commentary on its findings. (p. viii) First, the committee believes that each veteran who served as a human subject in the WWII experiments deserves honor for his sacrifice. These men risked their health and safety to help develop better means of protection against chemical warfare. Yet, in most
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Improving the Presumptive Disability Decision-Making Process for Veterans cases, their participation in these experiments was not even acknowledged in their service records and was, in fact, officially denied for decades. Further, these men were ordered to keep their participation secret. They did so for nearly 50 years, in some cases despite serious, disabling diseases that they believed were caused by their exposures. There can be no question that some veterans, who served our country with honor and at great personal cost were mistreated twice—first, in the secret testing and second, by the official denials that lasted for decades. They deserve recognition. (p. viii) Second, the committee believes that any future military research with human subjects should be conducted according to publicly established ethical principles similar to those that apply to civilian research. The Department of Defense should consider including civilian medical experts in reviews of all proposed military research protocols involving human subjects. As was shown in the examination and evaluation by the Department of the Army Inspector General’s report of the military drug and chemical testing programs from 1950 to 1975 … a climate of secrecy provides a permissive environment for the neglect of established rules of conduct. Such neglect should never be allowed to occur when human experimentation is involved. (pp. viii-ix) References IOM (Institution of Medicine). 1993. Veterans at risk: The health effects of mustard gas and lewisite. Washington, DC: National Academy Press.