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Improving the Presumptive Disability Decision-Making Process for Veterans 11 Governmental Classification and Secrecy BACKGROUND Secrecy surrounds many facets of homeland security issues and, in general, is of concern to national security. Many scientific studies conducted during the two world wars through the Cold War were classified, and many are still not declassified. Studies dealing with warfare gases and radiation were classified during the time of the studies and remain classified today. This classification makes appropriately informed treatment of the involved veterans with adverse health effects difficult, if not impossible, and impedes research on the consequences of exposures. The recent declassification of mustard gas and lewisite studies conducted during World War II and numerous radiation studies documented that classification greatly deterred treatment of health effects affecting the volunteers who played key roles during these studies. To many citizens, the idea of secrecy in government is linked with “national security secrets” or “classified information.” The system of classification occupies a special place in governmental secrecy. Classified information is accessible only to those who have been “cleared” following investigation and who agree to abide by the rules regarding access to this information; violation of these rules can result in severe criminal penalties. These rules can greatly hinder medical treatment of individuals who have been exposed during classified activities. The authority to classify information derives from legislation and from Presidential executive order. In 1917, Congress passed the Espionage Act to address wartime spying (SOURCE: http://www.firstworldwar.com/source/espionageact1918.htm; Gathering, Transmitting or Losing Defense Informa-
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Improving the Presumptive Disability Decision-Making Process for Veterans tion. 2007. 18 U.S.C. § 793; Gathering, or Delivering Defense Information to Aid Foreign Government. 2007. 18 U.S.C. § 794), and further legislation providing for military secrets was enacted in 1938 (Photographing and Sketching Defense Installations. 2007. 18 U.S.C. § 795; Use of Aircraft for Photographing Defense Installations. 2007. 18 U.S.C. § 796; Publication and Sale of Photographs of Defense. 2007. 18 U.S.C. § 797; Quist, 2002). In 1940 President Franklin D. Roosevelt issued the first executive order on classification, which was based on the authorization of the 1938 law enacted to protect military installations and equipment (Truman, 1950). The regulations that interpreted the World War I law declared that secrets could be kept not only for national security reasons but also for other reasons. In 1936, for example, the Army issued rules that provided for Secret, Confidential, and Restricted information. The definition of Confidential provided that A document will be classified and marked “Confidential” when the information it contains is of such nature that its disclosure, although not endangering our national security, might be prejudicial to the interests or prestige of the Nation, an individual, or any governmental activity, or be of advantage to a foreign nation. (Classification, 1936; emphasis added) Similarly, data could be classified Secret if release “might endanger the national security or cause serious injury to the interests or prestige of the Nation, an individual, or any government activity”(Classification, 1936). The use of classification and secrecy by the government is detailed exquisitely by the history of the formation of the Atomic Energy Commission and the development of the atomic bomb during World War II. The Advisory Committee on Human Radiation Experiments (ACHRE) Report (ACHRE, 1995) provides an extremely detailed chronology of the development of the classification scheme and the use of secrecy by the government as it relates to any aspect of radiation work. The history of use of the secrecy classification for radiation studies is outlined in Appendix L-1. Especially during times of national crisis the general public and the government take security seriously. The concern about national security has evolved considerably over the evolutionary period of classification. During World War II and the development of the atomic bomb under the Manhattan Project, considerable emphasis was placed on wartime secrecy. Secrecy and the oath of secrecy were extended not only to the actual participating scientists and staff but to families of these individuals. Appendix L-1 provides an overview of the secrecy concerns surrounding these projects. During this developmental time period, considerable emphasis was placed on secrecy surrounding the use of human volunteers, and that empha-
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Improving the Presumptive Disability Decision-Making Process for Veterans sis remains today. Some materials still remain classified today under the umbrella of national security. The historical development of the classification systems used during the atomic bomb era revealed that more than national security was a concern for classifying some material as secret. Concerns revolving around prestige, public relations, and governmental embarrassment were also used to invoke the secrecy umbrella. In public, some officials stated that national security was the paramount concern, while in private they endorsed the concerns involving prestige, public relations, and embarrassment (ACHRE, 1995). Declassification of materials has been slow, and many documents are still being withheld because of these expressed concerns. Although Appendix L-1 addresses the history of classification in relationship to the birth of the Atomic Energy Commission (AEC), the recent declassification of some of the World War II mustard gas and lewisite studies reveals that radiation studies were not the only studies classified for national security concerns (IOM, 1993). A more current example of this classification usage is the recent declassification of some of the SHAD (Shipboard Hazard and Defense) Project data, studies that were conducted and classified in the 1960s (SOURCE: http://www.deploymentlink.osd.mil/shad/factSheets.jsp). In view of these two chemical examples, concern arises as to how many other studies were classified secret and have not yet been declassified, leading potentially to the withholding of needed medical care from human participants in the studies. Although the written history addresses the experiences of the AEC (see Appendix L-1), the issues of secrecy and classification obviously could be extrapolated to other areas of research that would involve human subjects. Pertinent areas of concern in this regard would involve the use of chemical warfare agents for both prevention of injuries and possible use in tactical defense. The use of mustard agents and lewisite in studies addressing protective measures during and following World War II is a prime example of human subject use that was classified and remains partially classified today. Results from some of these studies were not declassified until the early 1990s at the insistence of an Institute of Medicine (IOM) study (IOM, 1993), and some studies remain classified today. The use of chemical warfare agents and simulants in the 1960s is a further example of retaining human studies under the umbrella of secret classification. In a series of tests under the project list of SHAD, Navy ships were exposed to chemical or biological agents or simulants to establish protective measures and decontamination efficiency for machinery and personnel (SOURCE: http://www.deploymentlink.osd.mil/shad/index.jsp; http://www1.va.gov/shad/; Brown, 2003). The numerous tests were classified as secret and have only been recently partially declassified, again at the insistence of an IOM study (IOM, 1993). In this example, the Department
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Improving the Presumptive Disability Decision-Making Process for Veterans of Defense (DoD) allowed IOM and the Department of Veterans Affairs (VA) personnel who possessed sufficient security clearance levels to review the documents and release selected pieces of information. It must be noted, however, that not all of the classified SHAD data have been declassified; only those parts that identify personnel involved, for which records were kept by DoD, and the agents or simulants they were potentially or actually exposed to have been declassified. These examples then bring to the forefront: How many other human use studies have been, or are being, conducted and are classified secret? In an August 2006 information letter released by the Veterans Health Administration (VHA) (VHA, 2006, p. 2), more than 250 chemicals were identified as chemicals of potential concern related to human use studies. DoD classification authority derives primarily from Presidential order. Currently the DoD Information Security Program (DoD, 1997) is the program used for classification and is based on Executive Order 12958 (Clinton, 1995) and its subsequent amendment Executive Order 13292 (Bush, 2003) addressing classified national security information. The current national security classification system is “designed primarily to protect the confidentiality of military, foreign policy, and intelligence information. It deals with only a small slice of the government information that requires protection although it drives the government’s security apparatus and most of its costs … the classification system, largely unchanged since the Eisenhower administration, has grown out of control. More information is being classified and for extended periods of time. Security rules have proliferated, becoming more complex yet remaining unrelated to the threat” (Pike, 2002). Today’s classification system “starts with three levels of classification (Confidential, Secret, and Top Secret), often referred to collectively as collateral national security information. Layered on top of these three levels are at least nine additional protection categories. These include DoD Special Access Programs, Department of Energy (DOE) Special Access Programs, Director of Central Intelligence Sensitive Compartmented Information Programs, and other material controlled by special access or bigot lists such as the war plans of the Joint Chiefs of Staff and the operational files and source information of the CIA Operations Directorate. Further complicating the system are restrictive markings and dissemination controls such as ORCON (originator controlled dissemination and extraction of information), WNINTEL (warning notice, intelligence sources and methods), NOFORN (not releasable to foreign nationals), and NOCONTRACT (not releasable to contractors)” (Pike, 2002).
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Improving the Presumptive Disability Decision-Making Process for Veterans LEVELS OF CLASSIFICATION Policies governing DoD’s classification program are implemented through the Information Security Program (DoD, 1997). This regulation implements Executive Order 12958 (Clinton, 1995), “Classified National Security Information,” and has been codified at 32 CFR Part 159 (DoD Information Security Program. 2001. 32 C.F.R. § 159). “A security clearance is a determination that a person is eligible for access to classified information. ‘Need to know’ is a determination made by a possessor of classified information that a prospective recipient, in the interest of national security, has a requirement for access to, or knowledge, or possession of the classified information in order to accomplish lawful and authorized government purposes” (Pike, 2002). Current levels of classification are broadly contained under the headings of Unclassified, Limited, Confidential, Secret, Top Secret, Limited Dissemination (LIMDIS), Special Access Program (SAP), and Sensitive Compartmented Information (SCI) (Pike, 2002). Appendix L-2 provides a discussion of each of the categories of unclassified and classified information control. No person may have access to classified information unless that person has been determined to be trustworthy and unless access is essential to the accomplishment of lawful and authorized government purposes, that is, the person has the appropriate security clearance and a need to know. Further, cleared personnel may not have access until they have been given an initial security briefing. Procedures are established by the head of each DoD component to prevent unnecessary access to classified information. (Pike, 2002) There must be a demonstrable need for access to classified information before a request for a personnel security clearance can be initiated. The number of people cleared and granted access to classified information is maintained at the minimum number that is consistent with operational requirements and needs. No one has a right to have access to classified information solely by virtue of rank or position. The final responsibility for determining whether an individual’s official duties require possession of or access to any element or item of classified information, and whether the individual has been granted the appropriate security clearance by proper authority, rests upon the individual who has authorized possession, knowledge, or control of the information and not upon the prospective recipient. (Pike, 2002) SECRECY AND MEDICAL RESEARCH Numerous aspects of medical research have been classified on the basis of national security and have only recently been brought to public light. The
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Improving the Presumptive Disability Decision-Making Process for Veterans ACHRE Report (ACHRE, 1995) enumerated numerous radiation studies conducted during and after World War II which were classified, and some still have not been declassified. Although the Espionage Act of 1918 really began the era of national security classification, more and more documents have been classified with each new Presidential administration (ACHRE, 1995; Quist, 2002). Today the system is complicated and burdensome to use as discussed above. Medical research is still conducted and classified under the aegis of national security. This secrecy classification can establish hindrances in the medical care provided to the participants in these studies. All institutions that participate in medical research have some degree of classification for their projects, depending upon funding sponsor, subject, and agents used. Much of the current research on modern nerve agents, for example, is classified at the secret and above levels, even though there are many unclassified documents on nerve agents available to the public (IOM, 1993). And while DoD participates extensively in classified medical research studies, VA has not been excluded from such activities. Chapter 13 of the ACHRE Report outlined VA participation in maintenance of “confidential” files regarding radiation studies: VA, similarly, was able to provide fragments of information that show that “confidential” files were kept in anticipation of potential radiation liability claims. However, neither the VA, nor the DOE and DoD (who evidently were parties to this secret record keeping), have been able to determine exactly what secret records were kept and what rules governed their collection and availability. (ACHRE, 1995, ch. 13) (As explained in Chapter 10 of the ACHRE Report, VA concluded that a “confidential” division contemplated in relation to secret record keeping was not activated.) VA publications did contain lists of several thousand (nonclassified) human experiments conducted at VA facilities; however, the information was quite fragmentary, and further information could not be readily retrieved (if it still exists) on the vast majority of these experiments. Thus, in looking for answers to questions about the secrecy of data on human experiments and intentional releases, we find record-keeping practices that leave questions about both what secrets were kept and what rules governed the keeping of secrets. (ACHRE, 1995, ch. 13) Medical research involving human subjects must follow certain ethical and standard practice guidelines such as those established by the Nuremberg Code of 1947 (Trials of War Criminals Before the Nuremberg Military Tribunals, 1949). The 10 key elements of the Nuremberg Code are outlined in Appendix L-3.
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Improving the Presumptive Disability Decision-Making Process for Veterans Some medical research studies conducted prior to the Nuremburg Code implementation might not have followed the precepts of the code. Congressional inquiries during 1975 and 1976 requested that the Army Inspector General review the use of human volunteers in chemical agent research (IOM, 1993). An excerpted summary of this review (Taylor and Johnson, 1975) is presented in Appendix L-4. While this report concentrated on psychochemical testing conducted during the period 1950-1975, it also addressed the history of chemical warfare testing using human volunteers and the degree of compliance with the Nuremberg Code (IOM, 1993). The overriding conclusion from this report was that the secrecy applied to research using human volunteers “left ample room for misinterpretation, lack of knowledge about [guidelines governing human volunteers] and outright disregard for established policies and guidelines” (Taylor and Johnson, 1975, as referenced in IOM, 1993, p. 379). Concern regarding these conclusions remains today. The issue of secrecy hindering medical treatment for veterans is amply exhibited in the IOM report Veterans at Risk: The Health Effects of Mustard Gas and Lewisite (IOM, 1993). Serious concerns were enumerated in the report over the secrecy issue demonstrated by DoD. These expanded concerns are presented in Appendix L-5. CONCLUSIONS AND RECOMMENDATIONS FROM IOM’S VETERANS AT RISK REPORT In Veterans at Risk (IOM, 1993), emphasis was placed on (1) the lack of exposure data, (2) the continuing dependence and reliance on secrecy by DoD, (3) serious ethical questions regarding the use of human volunteers, (4) total absence of long-term medical surveillance of participants, and (5) in some cases inadequate short-term follow-up even though medical knowledge was available as early as 1933 that exposure to mustard gas or lewisite could produce adverse health problems. The oath of secrecy taken by participants, and enforced by potential punishment protocols if broken, resulted in continual and escalating cases of health impairment among the human volunteers in these chemical agent studies. The Taylor and Johnson report contains specific statements addressing the issue of secrecy and the participants who took the secrecy oath. An overarching conclusion stated in the report addressed future DoD research with human subjects. These future studies must be conducted following a set of ethical principles that mirror those that non-DoD researchers must follow. The 1975 Army Inspector General report (Taylor and Johnson, 1975) concludes that the mantle of secrecy gives implicit permission to researchers to stretch the boundaries of ethical guidelines in DoD human research under the guise of national security.
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Improving the Presumptive Disability Decision-Making Process for Veterans VA acknowledges that it must, at times, request exposure data from DoD in order to make a compensation decision. These exposure data may or may not be classified by DoD, and DoD has the option of releasing the data to VA. If the data are classified, DoD may not release them to VA citing national security issues (as stated during Do, 2006, and Freeman, 2006). This failure to release exposure data hinders medical treatment to the veteran. The potential for negative impact on the veteran population is demonstrated in the August 2006 VHA information letter released to health-care providers and the public (VHA, 2006). In this letter, VHA indicated that there may be in excess of 250 additional chemical agents that were used or tested in the chemical warfare arena. The Committee does not know if there are data available on each of these chemicals or if the data are unclassified. DoD is the only organization that can provide those answers. DoD has acknowledged that some 250 additional chemicals might fall under this concern (VHA, 2006). If chemical studies have been classified, DoD is not obligated to inform VA about the studies under the umbrella of national security concerns. As discussed above in the levels of classification, there are many levels under which exposure data could be classified. And, if DoD were to impose the restriction on VA that they must identify which data and under which level of classification the data fall before they release the data to VA, this would hinder access to important information useful for the care of veterans. Not withstanding national security issues, VA must have access to all exposure data to fully provide health care to veterans. A high level of cooperation between both agencies is necessary to provide maximum support to the veteran population. SUMMARY In view of the history of human subject use in various DoD and other agency studies, a mechanism is needed to protect the health of our veterans and their families. A joint effort between DoD and VA must be initiated to develop a mechanism to monitor human studies and provide health-protection measures to those individuals involved. Foremost would be the identification of all Service members involved in the studies. Secondly, the chemical, biological, infectious, and radiological agents used during the studies must be identified so that potential adverse health effects and treatments can be determined. Thirdly, accurate exposure assessment data must be collected and made available to appropriate scientists to be used in determining treatment regimens. As is the case in issues of this concern, the “dose makes the poison.” Fourthly, national security concerns must be maintained while providing the necessary health support to veterans and their families. These areas of concern should be addressed by the formation of, and
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Improving the Presumptive Disability Decision-Making Process for Veterans effective and intelligent use of, a joint DoD-VA board to develop and implement policy areas surrounding national security and human subject research. Paramount to the effectiveness of the board, would be membership of individuals with sufficient security clearance to address national security, DoD weapons and tactical areas, and medical concerns, including exposure assessment. The major undertakings of this board would be the following: Identifying any human-use study Developing a registry of Service members involved in the studies Developing a tracking mechanism to maintain contact with the Service members involved in the studies Providing periodic medical evaluations or surveillance of Service members involved in the studies Determining appropriate medical treatment if an adverse health effect is detected Developing a mechanism to make information public as necessary Keeping the veteran, and family as applicable, fully informed regarding potential health effects of the materials that were used in the studies Recommendation DoD and VA should establish and implement mechanisms to identify, monitor, track, and medically treat individuals involved in research and other activities that have been classified and are secret. There are clearly times when national security or mission success depends on maintaining secrecy regarding certain aspects of a Service member’s military experience. However, every effort should be made to find mechanisms for characterizing Service member exposure and health histories in manners that do not interfere with the broader issues of national security or mission success. DoD should develop procedures that ensure full or partial declassification of sensitive information for the timely provision of that Service member’s or veteran’s health care. When such declassification is not possible, DoD should establish procedures whereby blinded data relevant to the Service member’s health and exposure history are provided. In some instances where national security and secrecy issues cannot be resolved, DoD and VA may need to establish mechanisms involving experts with appropriate security clearances to monitor affected registry cohorts for potential health outcomes and define surveillance or research activities that may need to be conducted within appropriate secrecy clearances. An
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Improving the Presumptive Disability Decision-Making Process for Veterans interagency agreement could be developed between DoD and VA addressing the secrecy issue. As both agencies have used the classification system in the past, this agreement would address the policy development process and the exchange of classified information between the two agencies. The process would include establishment of a joint DoD-VA board composed of individuals who have sufficient security clearance to discuss classified data. The access to the classified information process would be contained in a written document outlining a mechanism to identify, monitor, track, and medically treat individuals who were part of research activities involving human subjects and whose research design and results have been classified. 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). Brown, M. 2003. VA charge to the IOM Oversight Committee on the Study of the Health of Participants in Project SHAD (Shipboard Hazard and Defense). Washington, DC: Department of Veterans Affairs. http://www1.va.gov/shad/docs/VA_Charge_IOM_on_the_Health_Study_of_SHAD.pdf (accessed March 7, 2007). Bush, G. W. 2003. Executive order 13292: Further amendment to executive order 12958, as amended, classified national security information. Federal Register 68(60):15315-15334. http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/pdf/03-7736.pdf (accessed March 7, 2007). Classification. 1936. Dictionary of Unites States Army terms: Army regulation 320-5. Attachment 2. Washington, DC: Government Printing Office. http://www.gwu.edu/~nsarchiv/radiation/dir/mstreet/commeet/meet14/brief14/tab_d/br14d1b.txt (accessed March 7, 2007). Clinton, W. J. 1995. Executive order 12958: Classified national security information. Federal Register 60(76):19825-19843. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=1995_register&docid=fr20ap95-135.pdf (accessed March 7, 2007). Do, N. 2006. DoD and Veterans Affairs: Health information sharing. Paper presented at the third meeting of the IOM’s Committee on the Evaluation of the Presumptive Disability Decision-Making Process for Veterans, San Antonio, TX. DoD (Department of Defense). 1997. Information Security Program. DoD 5200.1-R. Washington, DC: Office of the Assistant Secretary of Defense/Command, Control, Communications, and Intelligence. http://www.fas.org/irp/doddir/dod/5200-1r/ (accessed March 7, 2007). Freeman, C. 2006. Department of Veterans Affairs/Department of Defense: Health data systems interoperability. A presentation to the Institute of Medicine Committee on the Evaluation of the Presumptive Disability Decision-Making Process for Veterans, San Antonio, TX. IOM (Institute of Medicine). 1993. Veterans at risk: The health effects of mustard gas and lewisite. Washington, DC: National Academy Press. 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).
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Improving the Presumptive Disability Decision-Making Process for Veterans Quist, A. S. 2002. Introduction, history, and adverse impacts. Vol. 1. Oak Ridge, TN: Oak Ridge Classification Associates, LLC. http://www.fas.org/sgp/library/quist/index.html (accessed March 7, 2007). 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. 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). Truman, H. S. 1950. Executive order 10104: Defining certain vital military and naval installations and equipment as required protection against the general dissemination of information relative thereto. http://www.presidency.ucsb.edu/ws/index.php?pid=59321 (accessed April 10, 2007). VHA (Veterans Health Administration). 2006. Under Secretary for Health Information Letter: Potential health effects among veterans involved in military chemical warfare agent experiments conducted from 1955 to 1975. Information letter 10-2006-010. Washington, DC: Department of Veterans Affairs. http://www1.va.gov/environagents/docs/USHInfoLetterIL10-2006-010.pdf (accessed March 7, 2007).