Statement of Secretary of Energy, Hazel R. O'leary Before the Committee on Governmental Affairs, US Senate, Concerning Human Radiation Experiments, January 25, 1994. Includes Statement of the H ...

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Mr. Chairman and Members of the Committee: I am pleased to have the opportunity to appear before the Committee this morning. At the outset I want to recognize the long-standing and active interest of this Committee in the well being of workers and members of the public who are at risk due to radiation and other toxic exposures resulting from nuclear weapons production. This Committee has done the public and the Department of Energy a great service over the past several years through its efforts to shed light on the range and complexity of occupational hazards and environmental problems confronting the Department. I am therefore particularly pleased to come before you to speak about recent reports of potentially unethical conduct involving experiments using radiation on human subjects during the Cold War. As you know, this subject has generated intense public and media attention over the past several weeks. During this time, I have spoken with many Americans around the country, some of whom were experimental subjects or the relatives of subjects. They have been deeply troubled, as I was, by these I have been asked frequently why these activities were allowed to take place. Some have expressed the view that they were motivated by concern about a need to counter Soviet threats of nuclear war and the atmosphere of secrecy that surrounded research in nuclear energy and ionizing radiation since the Manhattan Project. With the end of the Cold War and President Clinton's strong commitment to openness in government these conditions have

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This change has brought about a unique opportunity for the nation to debate important questions raised by some of the human radiation experiments -- questions about the role of secrecy in a democratic society, and the need for proper safeguards to ensure the rights of individuals to determine their own fates. we must take the necessary steps to ensure all Americans - whether they are uneducated or poor or mentally retarded or incarcerated - that they are not being used unwittingly in Federally-sponsored research. The Clinton Administration is determined to disclose all records on experiments involving ionizing radiation on humans. In a moment, I will discuss the steps we are taking to release information as quickly as possible, to ensure that we have a serious, thoughtful debate about the lessons these experiments teach us, and to make sure that the highest standards of ethical and scientific conduct are followed in all research involving human beings. As we examine this dark and narrow corner of scientific experimentation, we must keep in mind several points. As unsettling as some of these experiments were, and as feared as radiation may be to many people, it is important to remember that many lives have been saved using radiation in the diagnosis and treatment of disease. During the same Cold War period that some scientists were conducting these controversial experiments, other scientists were inventing vaccines against polio, new and effective treatments for cancer, and new ways of visualizing the human body with CAT and cardiac scans. Science itself is not at issue here. What is at issue is the secrecy with which some scientists may have practiced their \\

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i also want to caution the American public against inordinate fear of current research practices. Institutional Review Boards enforce strict requirements for informed consent of any human subjects involved in scientific experiments. It is difficult to conceive of the ethical abuses about which we’ve been hearing occurring today in the United States. As I will describe, we are committed to a serious review of all experiments sponsored or camed out by government agencies that involved intentional human exposure to ionizing radiation. We will use the results of this review to try and repair any wrongs that might have been done, and will, if necessary, take action to make today’s standards even more stringent. President Clinton’s Commitment to Ouenness in Government This Administration recognizes that public trust can only be achieved if American citizens believe that their government is open, truthful, and accountable. Since the earliest days of his campaign, President Clinton has been publicly committed to an open and responsive government. The openness initiative that I began at the Department of Energy last spring was a direct outgrowth of this commitment. The Department of Energy’s Openness Initiative On December 7, 1993, I held a press conference at which we released important information that had previously been classified. I revealed, for example, that 204 previously unannounced nuclear tests - one out of every five United States tests - had been kept secret. The Cold War rationale for this secrecy was the desire to inhibit Soviet monitoring of our

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weapons testing program. In addition, we revealed the locations and quantities of the United States weapons grade plutonium stockpile and the amount of mercury used in Also during that press conference, I acknowledged, as was revealed in a 1986 House Subcommittee Report and as recent press accounts describe, that 18 persons were injected with plutonium as part of an experiment sponsored by the Atomic Energy Commission in the 1940’s. The records available strongly indicate that some of these subjects may not have been fully informed of the purpose or risks of the experiment. Subsequent to that press conference, a number of reports describing other radiation experiments appeared in the media, including a report on a nutrition study conducted at Vanderbilt University in Nashville, Tennessee. This study involved the administration of radioactive iron to pregnant women. The study was designed as part of an effort to understand dietary iron needs during pregnancy. The Atomic Energy Commission supplied the radioisotopes used in this experiment. As with other press reports on human radiation experiments, the Department of Energy is gathering any relevant records. The DeDartment of Enerw’s Aptxoach to Declassification The important expanding involvement of members of the public, workers, scientists, and others in the activities of the Department of Energy has resulted in a significant increase in requests over the past few years for Departmental records, many of which are classified or

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contain restricted data. Nuclear proliferationremains, of course, a national security concern. However, dramatic changes over the past few years in the international arena have significantly reduced the classification requirements for much information and, after proper review, such information will be released to the public. A significant number of Department of Energy records requiring systematic review, are currently held by the National Archives and Records Administration. The Department of Energy has agreed to transfer additional Atomic Energy Commission records to the Archives. In order to deal with this large volume of classified records, the Department is providing the Archives with authorized reviewers to work in a systematic declassification program. We are also working closely with the Department of Defense to review appropriate information for declassification. The benefits of our declassification initiative include an enhanced ability to fill in the blanks of Cold War history -- including the public disclosure of documents relevant to radiation experiments; improved studies of the health and safety of Department workers and the public; and increased trust in government. Also, through this initiative, the United States sets an example for other nuclear nations to follow. We recognize, however, that there is a continued need to balance our declassification needs with our nonproliferation objectives. State of Present Knowledge on Radiation Emeriments We do not yet know if the radiation experiments noted in the 1986 Congressional Report by the House Energy, Conservation and Power Subcommittee and the experiments involving deliberate environmental releases discussed in the General Accounting Office Report prepared for this Committee in December of last year, comprise the bulk of experiments that might be subject to questions of scientific and ethical propriety. We also do not yet

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know the full extent of the records pertaining to Department of Energy-sponsored experiments that need to be examined. I am taking action to assure that the records search being conducted by the Department of Energy and its contractors will be thorough and comprehensive as we endeavor to tell the full story. At the Department of Energy, we have developed an action plan to expedite the identification, retrieval, management, declassification, and dissemination of information regarding human radiation experiments. Department of Energy personnel have been directed to cease routine and non-routine destruction of documents and to identify all pertinent records and information in the Department’s possession and in the possession of our laboratories and contractors. I have established a multi-disciplinary committee under the authority of the Assistant Secretary for Environment, Safety and Health. The Committee is issuing detailed guidance to the field. The committee includes specialists in health, environment, and legal issues among other disciplines. The Department, both at Headquarters and in the field, has already undertaken activities to begin to collect and review the pertinent documents. For example, over 130 cubic feet of files have been collected and are being reviewed at Under the Department’s action plan: 1. The Committee is developing guidance and will facilitate the process by which all records are identified, retrieved, inventoried, declassified, stored, and disseminated. Teams of similar makeup and functions are being established in the field to assure that the process is expedited. 2. Field and Program elements are also documenting the procedures used to search for, retrieve, and inventory the pertinent records.

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3. The Assistant Secretary for Environment, Safety and Health has established a team of professionals to oversee the retrieval process and assist field activities. We will begin to develop these teams within the next two weeks, 4. We are establishing a permanent repository for pertinent- records and procedures for shipment to the repository on an expedited basis. 5. Finally, to meet this long term need, the Department of Energy is establishing a permanent organization entity having responsibility for carrying out the process. Allow me to stress that our goal is to get all the facts out. We will also do our best to provide information as we learn it. All pertinent information that is found regarding human i experimentation will be declassified as necessary on an expedited basis and permanently 1i preserved for public review in an appropriate public archive. At the same time, we are taking appropriate steps to protect the privacy of people who were the subjects of experiments as well as their families. From what we know thus far, human experiments involving ionizing radiation conducted or sponsored by the Department of Energy or its predecessor agencies fall into one of four 1. Experiments designed to investigate the effects of radiation on humans or the way the human body metabolizes radioactive substances; 2. Experiments using radioisotopes as tools to study the biochemistry of normal 3. Experiments designed to investigate the therapeutic uses of radiation in the treatment of diseases such as cancer; and 4. Experiments involving intentional releases of radiation to the environment for purposes of assessing the behavior of such releases.

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Some of the More Troubling Aspects of the Experiments The radiation experiments that have come to light are disturbing for several reasons. It is not clear that all subjects were properly informed of the purposes or risks associated with the experiments in which they were participants. - -.- Some of the experiments also raise questions about how the experimental subjects were selected. There is, at least on first inspection, the appearance of a pattern of choosing subjects from relatively vulnerable populations such as persons of color, poor people, prisoners, and retarded children. This appearance of treating some citizens as “expendable,” to use Congressman Markey’s phrase, is especially repugnant in a country that prides itself on its diversity, and that has, as its goal, providing equal opportunity for all its citizens. Current ExDeriments Involviw Human Subjects Regarding press reports on the Department’scurrent projects, we are funding approximately 120 experiments, and providing facilities for another 100 experiments involving human subjects. Not all of those experiments involve radiation, and the majority of those that do relate to nuclear medicine involve the use of low tracer doses. To illustrate, there are 24 studies at Los Alamos National Laboratory under the purview of their Institutional Review Board. In no case is there any exposure of living human subjects to radioactive or chemical agents. In addition, none of these projects is classified. The Office of Energy Research is preparing a list of all Department of Energy experiments identified by institution, title, principal investigator, and funding source. We estimate that the total funding of these projects is approximately $SO million.

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The complete details of all human subject experiments conducted by the Department, or at Departmental facilities (including funding, loation, number of volunteers, procedures, and other agency contributors) will be available on a computer retrievable data base by March 15, 1994. The data base will serve the Department of Energy clearinghouse for ail current and future experiments involving human subjects. The data base of human subject experiments resides in the Office of Health and Environmental Research which funds most of those studies and is charged with oversight of the human subject regulations. Dr. Susan Rose from that office is the manager of this I have asked the Health and Environmental Research Advisory Committee of the Department to review compliance by Department of Energy facilities with the human subject regulations (including the informed consent issue) and report to me by June 1994. This statutory group of outside experts, who advise the Department on health and environmental research matters, will also examine the relative merits of decentralized Institutional Review Boards versus more centralized clearinghouse concepts. As far as we have been able to ascertain, the Department is not conducting any experiments that violate medical, ethical standards, or the Nuremburg code. All Department of Energy experiments are, we believe, in compliance with the Federal Policy on Protection of Human Subjects. The Department of Energy assisted in drafting this Federal Policy during the 1980s and adopted it along with 16 other Federal agencies (including the Department of Health and Human Services) in July 1991, when the rulemaking process was complete. In another case, Brookhaven National Laboratory has 42 projects under the purview of its Institutional Review Board. These are nuclear medicine studies that use low dose tracers. Additionally,

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Department of Energy procedures call for all volunteers in Departmental projects to be fully informed on all the procedures used. Human Radiation Interagency Working Group - -. On January 3, 1994, the White House convened a meeting of senior staff from government agencies with potential involvement in human radiation experiments. The White House has established a Human Radiation Interagency Working Group consisting of myself and the Secretaries of Defense, Health and Human Services, and Veterans Affairs. The Directors of the Central Intelligence Agency and the Office of Management and Budget, the Attorney General, and the Administrator of the National Aeronautics and Space Administration are also on the Working Group. Five subcommittees have been formed under the Working Group to address the following specific issues: 1) Public Information and Communications; 2) Retrieval and Review of Records; 3) Ethical and Scientific Standards; 4) Congressional Relations; and 5 ) Legal Issues. These …