Mr. Chairman and Members of the Committee, thank you for the opportunity to appear before the Committee today and provide you with an update on the continuing work of the Department of Energy (DOE) in response to the human radiation experiments initiative. I will speak to you today both in my capacity as Assistant Secretary of Energy for Environment, Safety and Health, and as the chair of the staff of the Interagency Working Group (IAWG), which has been directed by President Clinton to respond to the recommendations of the Advisory Committee on Human Radiation Experiments. The IAWG was established in January 1994 to coordinate the government's response to human radiation experiment issues and consists of the Cabinet Secretaries of the Departments of Energy, Health and Human Services (HHS), Defense (DOD), and Veterans Affairs (VA), the Attorney General (DOJ), the Administrator of the National Aeronautics and Space Administration (NASA), and the Directors of the Central Intelligence Agency (CIA), and Office of Management and Budget (OMB).
My testimony will cover recent activities of the IAWG staff, including preparation of a draft preliminary response to the recommendations of the Advisory Committee on Human Radiation Experiments. These recommendations are the result of 18 months of intense deliberation, the review of thousands of documents, and public meetings both in Washington and across the country that involved presentations by many concerned citizens. Two weeks ago, the Administration sponsored a two-day stakeholder workshop to receive input to this draft response. The IAWG staff are actively seeking ways to make human radiation experiment information more useful and accessible to citizens.
I will also discuss the work being done by DOE to carry out the human radiation experiments initiative begun over two years ago, and to keep this effort strong. We are working closely with citizens and stakeholders to respond to specific inquiries. We actively continue to locate, release, declassify, and generally improve access to DOE records and information on this and related subjects.
Finally, the Administration is working to improve protections for citizens who are subjects in current human subjects research. President Clinton's October 1995 Executive Order required Federal agencies to review their entire program of current human subjects research in light of the Advisory Committee's recommendations and to report on this review to the National Bioethics Advisory Commission. The Office of Energy Research has completed this requirement and is now engaged in: a systematic review of DOE site activities in relation to human subjects protection; efforts to improve informed consent documentation; and efforts to better educate scientists, administrators, and Institutional Review Board (IRB) members about their responsibilities in the area of human subjects protection.
Let me emphasize the continuing commitment of President Clinton, Secretary O'Leary, and the entire IAWG to make government accountable to the people, make information about government activities easily available, be responsive to citizen concerns, and seek citizen input on the range of issues associated with the human radiation experiments effort.
The issue of government sponsored human radiation experiments has been examined with increasing intensity over the past two decades. In the mid-1970s, then-Representative Al Gore chaired hearings which focused on whole body irradiation treatments for cancer patients, conducted by the Oak Ridge Institute of Nuclear Studies. No final report was issued and no wrongdoing found.
Representative Ed Markey chaired hearings in 1986 and issued the report, "Human Guinea Pigs", which detailed experiments involving some 600 human subjects. The "plutonium experiments" were publicly discussed in detail in this report. The research involved in "Human Guinea Pigs" served as a starting point for the exhaustive search to come in the 1990s.
In late 1993, Eileen Welsome's Pulitzer-Prize winning investigative report for the Albuquerque Tribune on the plutonium injection subjects brought the topic to the attention of Energy Secretary Hazel O'Leary. Secretary O'Leary's outrage, expressed in a December 1993 press conference on openness in DOE, inspired tremendous media response and public outcry. The Human Radiation Experiments Helpline was immediately established and received over 17,000 calls from citizens in the first month alone. President Clinton promptly issued an Executive Order directing all relevant Federal agencies to search their records for information on radiation experiments.
This Executive Order also established the IAWG in early 1994. Individual agencies organized research teams to locate and examine records. The extensive DOE search for records of Department of Energy and predecessor agency human radiation experimentation was difficult for a number of reasons. The records universe to be searched was huge -- an estimated 3.2 million cubic feet (one cubic foot is about the size of a case of Coca Cola bottles and contains between 2,500 and 3,000 pages!). Moreover, these records were in multiple locations and geographically dispersed from coast to coast.
In addition, there was no single subject index or finding aid to help DOE's Office of Human Radiation Experiments (OHRE) sort through this records universe. Most human experimentation records had been created more than twenty years ago and few in DOE were familiar with such old records. The records were created by decentralized governmental and contractor institutions with substantial autonomy. As a result, there were few central files arranged according to standardized filing schemes. Some files had been reorganized and moved over the years, so that what were once single collections stored in one place might now be three or four stored in two to four different places. Most of the records had originally been created for purposes other than facilitating a search for documentation on human radiation experiments and therefore did not easily lend themselves to this search. Over 200 people from the Department were involved in this search process.
One important purpose of the records search was to provide the Advisory Committee on Human Radiation Experiments with documents for review. The Advisory Committee membership, appointed by President Clinton in early 1994, was charged with advising the IAWG and the President of the ethical implications of the experiments. The Committee included medical doctors, radiation biologists, lawyers, ethicists, historians, and one citizen representative. When the Advisory Committee was formed, we had no idea of the number of government sponsored radiation experiments or the extent of the documentation that would have to be reviewed. The Executive Order establishing the Committee required a review of radiation experiments from 1944 to 1974, which was the year of the first Federal regulations protecting human subjects, and to sample later experiments for ethical problems. The Advisory Committee also investigated the adequacy of present-day informed consent documentation by reviewing a sample of current research projects.
The Advisory Committee members and staff reviewed hundreds of thousands of documents and spoke with hundreds of citizens and stakeholders. The Committee's meetings and research took them across the country in search of information. All Advisory Committee meetings were held in public, in accord with the Federal Advisory Committee Act (FACA) and all drafts of the Committee's interim and final reports were also public. The charter of the Committee was extended to 18 months, at the Committee's request, to allow a more thorough review and deliberation. The Committee's final conclusions were presented to President Clinton in a 900 page report on October 3, 1995.
At the White House ceremony in which President Clinton accepted the Committee's report, he apologized to the victims. "While most of the tests were ethical by any standards, some were unethical, not only by today's standards, but by the standards of the time in which they were conducted. They failed both the test of our national values and the test of humanity...So today," he said, "on behalf of another generation of American leaders and another generation of American citizens, the United States of America offers a sincere apology to those of our citizens who were subjected to these experiments, to their families, and their communities."
The same day, President Clinton signed an Executive Order establishing the National Bioethics Advisory Commission (NBAC), which will continuously review and identify principles governing human subjects research. President Clinton simultaneously directed all Federal agencies sponsoring human subjects research to review and improve their human subjects protections in light of the Advisory Committee's recommendations and to report on this review to NBAC. He also instructed the Cabinet to use and build on these recommendations to devise a system of relief, including compensation, where appropriate, that meets the standards of justice and conscience.
In response to the 18 recommendations in the Advisory Committee's final report, the IAWG staff has drafted a preliminary paper which lays out a proposed set of government actions. The government continued in its commitment to public involvement by receiving citizen input on this draft during a two-day stakeholder/citizen workshop sponsored by the IAWG staff at the end of February 1996. Over 120 people participated in the workshop, including citizens who believe they were/are experiment subjects, their advocates, government representatives, and invited experts. Discussion was intense and stakeholders were highly critical of the Committee's recommendations, as well as the preliminary proposed government response. Citizens want the government to respond to a wide range of matters relating to radiation exposures, many of which do not fall under the category of "human radiation experiments" as defined in the Advisory Committee's charge.
In response to strong citizen concerns expressed at the workshop, the IAWG staff is examining ways to involve the public more extensively in government decisionmaking on the issues of human subjects research. Citizen proposals include:
The reform of the IRB process to include greater citizen representation and more effective, community-based review of human subjects research;
Facilitation of better access to government decisionmakers for citizen groups; and
Ways to enable citizens to work with government to develop appropriate search tools to help members of the public independently access information about human radiation experiments..
Two important and potentially controversial issues raised by the Advisory Committee recommendations are compensation and medical follow-up and notification for human radiation subjects. As to the issue of compensation, representatives of the families of most, if not all, of the subjects identified by the Advisory Committee have already pursued claims against the government and the Administration has engaged or will engage in discussions with them.
In the areas of subject notification and medical follow-up, citizens at the stakeholder workshop criticized the Advisory Committee recommendations and the IAWG staff draft responses. They advocated the notification of all subjects who have participated in government sponsored radiation experiments and the provision of funds for comprehensive medical care, managed at the local level, for all persons involved in the experiments.
The following discussion sets forth the salient issues on this topic.
The Advisory Committee recommended against notification and medical follow-up of human radiation experiment participants because two criteria were not met. The Committee recommended that these two criteria form the basis for decisions on notification and medical follow-up. The criteria were:
Risk, including both the remaining lifetime risk of mortality from the exposure and the potential risks from medical follow-up; and
The medical utility of early detection and treatment for changing the course of disease or the quality or length of life.
Should other experiments of concern come to light in the future, these criteria should govern the decision to notify subjects and pursue monitoring interventions.
It is an unfortunate fact that the practical, logistical task of identifying, locating, and notifying participants in past government sponsored radiation experiments and/or their descendants would entail an enormously expensive, time-consuming effort that promises to be futile in most cases.
Although the Advisory Committee's database includes documentation describing approximately 4,000 government-sponsored human radiation experiments, no list of participants exists for most of the experiments. For example, 3,000 of the 4,000 experiments were sponsored by the VA. According to Advisory Committee staff, there are subject names for only a tiny fraction of these experiments. In the isolated cases where participant lists are available, scores of researchers would be needed to track down persons whose whereabouts have been unknown to the government for several decades. It is probable that most subjects have changed names, died, or moved to other parts of the country and to locations around the globe.
The Advisory Committee also felt that there would be little or no medical benefit to subjects -- and possibly new risks -- from this vast endeavor. These potential risks include medical harm and discomfort, the possibility of incorrect test results, the possibility of stigmatization by friends, family, insurers, and employers, and potential financial costs to the subjects and their families.
In the Advisory Committee's judgment, almost all of the experiments involved small radiation doses, producing less than 1/1,000 remaining lifetime risk of cancer death. This level is minimal compared with the normal risk of dying of cancer (220 out of 1,000). Many of the experiments involved tracer doses, similar to those used in medical diagnostic procedures today to diagnose cancer and heart disease.
The unfortunate reality is that there are very few effective screening procedures for the detection of an early-stage cancer. Medicine, with all the progress made over the past 50 years, does not have -- with few exceptions -- accepted methods of detecting cancer early that can result in prolongation of life or altering the course of disease in persons who are not known to be at high risk for cancer. Our health care system and the vast bulk of medical research efforts emphasize the treatment of disease, not its prevention.
With regard to brain, head, and neck cancers among children and military personnel exposed to nasopharyngeal radium treatments, the Advisory Committee did find that these subjects exceeded the 1/1,000 threshold for lifetime cancer risk but they found neither an accepted nor a recommended screening procedure for these tissues. A recent conference on this subject, jointly sponsored by the VA, Centers for Disease Control, and Yale University, did not recommend notification of these subjects. However, the question of what, if any, follow-up these individuals should receive remains controversial.
In addition, the Advisory Committee found no persuasive evidence to indicate that subjects of human radiation experiments have greater likelihood than the general population of incurring genetic effects, meaning those effects passed on to children of experiment subjects. Again, this is not surprising since the decades of research on atomic bomb survivors -- exposed to vastly more radiation -- have not detected genetic effects. Therefore, the Advisory Committee did not recommend notification or medical follow-up for descendants of subjects of human radiation experiments.
We recognize the anguish that subjects and their descendants may feel, even when there is little the government may be able do for them. The position of the IAWG staff on these issues has not yet been finalized. There is currently no Federal program that compensates citizens harmed in the course of Federally-sponsored research. Our concern and sympathy for those who were subjects of experiments must be balanced against the fact that the provision of government sponsored medical insurance to experiment participants could be fraught with difficulties. There are also important questions of parity with citizens exposed to chemicals, drugs, or radiation from other government activities.
Notification and follow-up are among the most contentious aspects of the Advisory Committee report. Our compassion for citizens who were unwitting participants should -- first and foremost -- fuel efforts to prevent this type of behavior by government and future researchers.
This preliminary draft Federal response to the Advisory Committee recommendations remains a work in progress. A variety of options, including both those generated by government representatives and by stakeholders, are still under discussion. These options are being reviewed for fairness, cost-effectiveness, responsiveness to public concerns, and consistency with Administration policies and with the Department's openness initiative.
DOE wants to take this opportunity to report on the achievements of the Office of Energy Research and our continuing hard work in the area of human radiation experiments. We maintain an ongoing program to work closely with citizens and stakeholders to provide information about past human radiation experiments. Case managers continue to review DOE records and research constituent inquiries. More than 3,000 cases have been intensively researched, responding to over 16,000 inquiries from the public and members of Congress. DOE has sent more than 20,000 responses to citizens, from acknowledgement of inquiries to determination of the extent of participation in experiments.
The Department continues to locate and make available records and information relating to human radiation research. DOE has already located over 250,000 pages of documents that are available in hard copy at a number of locations. They are also on the Internet in such a way that they can be searched, viewed, and printed in their original forms. Many more cubic feet of records were provided to the Advisory Committee for their review and more than 6,000 documents have been declassified for this project.
DOE has also published three important reports which serve as useful research tools:
Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records, released in February 1995, includes project background, site histories, records series descriptions, topical essays, and a preliminary list of experiments.
Human Radiation Experiments Associated with the United States Department of Energy and its Predecessors, released in July 1995, contains a listing, description, and selected references for 435 documented human radiation studies dating back to World War II.
In addition, we also conducted quality assurance reviews of the search methodologies at 17 field facilities and DOE headquarters to ensure that record searches complied with guidance and that the search was credible and thorough. These reviews resulted from a commitment to the General Accounting Office and to Senator Glenn that DOE would do a quality check on human radiation experiment project activities across the complex. Teams were sent to each site to ensure that the site followed the OHRE guidance, and to determine whether the search was properly documented and any outstanding sources of information remained to be investigated. The teams performed random searches through site finding aids and document files to test whether any pertinent collections had been overlooked.
At each stage of this search effort, the Department has documented what was done and why. This will enable those who come after us to know where we have been and what we have done. Our goal is not to have the final word, but to leave behind a record of our activities that historians, policymakers, Congress, and the American people can use to understand, debate, and evaluate this aspect of our history.
The activities in which we are now actively engaged are logical extensions of the path DOE has followed throughout this project. The Advisory Committee recommended that DOE transfer a number of important collections of records to the National Archives, and the two agencies are currently negotiating the transfer of over 3,500 cubic feet of DOE records for the National Archives' permanent collection. Also, in response to an Advisory Committee recommendation, DOE has initiated a project to place "finding aids," that will improve access to those records still in DOE custody, in agency reading rooms across the country. In addition, DOE is working closely with DOD to help ensure that all documents from IAWG agencies are accessible via the Internet, using the same search tools currently employed for the DOE documents.
As additional experiments or documents are located, they are incorporated into the DOE information system in both electronic and hard copy format. The Department is continuing an active program of declassification review in response to the President's recent Executive Order.
The Department of Energy provides special medical care and logistical support to the remaining population of the Rongelap and Utirik atolls of the Republic of the Marshall Islands (RMI) who were exposed to radiation, resulting from the 1954 United States thermonuclear "Bravo" test. The Marshallese were not specifically included in the Advisory Committee's charter for two primary reasons. First, the Rongelap and Utirik populations were exposed to radiation, not as part of human experimentation, but rather through fallout as a result of the U.S. nuclear weapons testing program. Second, as noted above, a lifetime program of medical care and compensation, supported by the Department, is already in place for these exposed populations.
The Department's medical program currently provides twice a year medical screening and full medical care for radiogenic conditions for the remaining 137 out of 253 exposed Rongelap and Utirik individuals. Any exposed person who has medical findings suggesting a malignant neoplasm, or other radiation-related disease, is referred to secondary or tertiary medical facilities for definitive evaluation and therapy. Those persons with problems that can be effectively managed in Majuro or Kwajalein are referred to the Marshallese Health Services. Those requiring a more extensive evaluation are referred to hospitals in Honolulu or, for the special cases of thyroid and pituitary lesions, the National Institutes of Health in Bethesda, Maryland.
The Department started, during 1995, to transition from previous vessel-based medical missions to land-based medical missions. Vessel-based missions were handicapped by the inability to keep a vessel equipped with state-of-the art medical equipment. The land-based approach will improve the quality and affect cost efficiencies in medical care for the exposed populations in Rongelap and Utirik. This approach will make available, at existing Marshall Islands' medical facilities, more sophisticated diagnostic equipment and improved laboratory analytical capabilities for the aging Rongelap and Utirik populations. Examples of improvements offered by land-based medical capabilities include:
Year-round use of newly purchased current ultrasound equipment;
Immediate diagnosis of thyroid nodules, ability to do immediate fine needle aspiration or thyroid surgery locally in the RMI as well as surgical removal of gastrointestinal tumors;
Availability of certified mammography equipment at Kwajalein which meets the higher more stringent U.S. mammography standards for mammography equipment and technician qualifications; and
Better radiography capabilities and diagnostics permitting immediate follow-up, additional tests and surgery when needed.
As with vessel-based care, the land-based system will provide continued visits to infirm patients in their homes at Mejatto and Utirik with the added ability to provide full diagnostics and tests of samples taken right after the visit to these remote islands at the newly-established land-based facilities. Because of the limited diagnostic equipment on the vessel, many of these samples were formerly shipped to the U.S. mainland for analysis.
The Advisory Committee recommended that the Department's medical program for citizens of the Marshall Islands continue, as long as any members of the exposed population remain alive. The Department has no plans to discontinue its program of surveillance, screening, and medical care for the Marshallese people.
The Advisory Committee also recommended that DOE's program be reviewed to determine if expansion to include other Marshallese populations is warranted. Based on an evaluation of currently available radiation exposure data, the Department does not believe there is a need for the expansion of the Marshall Islands medical program. For example, current data show that the radiation doses to the thyroids of the exposed individuals in the mid-belt atolls (i.e., Ailuk and Likiep) are only 10 to 25 percent of the doses received by exposed individual at Utirik. Nevertheless, the Department is funding an RMI-requested study by the Centers for Disease Control and Prevention (CDC) to compare the incidence rates of benign and malignant thyroid cancer in populations throughout the Marshall Islands and to estimate the dose response for radioactive fallout and thyroid neoplasm. This feasibility study is to be completed by June 1996, with a presentation of results to RMI by September 1996. The results of this study will need to be evaluated jointly by CDC, DOE, and the Marshallese in light of existing data to determine the scientific basis for expanding the Department's current medical screening and medical care program.
Finally, the Committee recommended that the government consider whether the Marshallese people should be involved in future research decisions that affect them and that an independent review be conducted of the current DOE medical program. The government of RMI has agreed with the Advisory Committee in requesting an independent evaluation of DOE's program. The RMI government wants a review process in which they can fully participate. The Department is in the process of consulting with the Marshallese on the various approaches which can be used to accomplish this goal. The Department anticipates that its mission in the Marshall Islands will remain a clinical one and will continue not to involve medical research.
Research on humans performed in accordance with ethical and humanitarian principles allows experiments to be performed that provide medical and scientific benefits to individuals and to the Nation. Medical research led to the development of the polio vaccine. Radiation research brought us treatments for cancer and diagnostic procedures to pinpoint medical problems. It is important to remember that many lives have been saved and many more will be saved using diagnoses and treatments of diseases derived through medical research.
Federal regulations have been promulgated to assure that human subjects are fully protected from potential abuses in research experimentation. It is the policy of the Department that the rights and welfare of human subjects involved in research supported or sanctioned by DOE be protected in accordance with the Federal Policy for the Protection of Human Subjects and, until the requirements of DOE policies and orders have been met, no site research activity involving human subjects shall be initiated.
DOE is improving protections for citizens who are subjects in DOE-sponsored current human research. This is an ongoing, active DOE program into which the recommendations of the Advisory Committee have been incorporated. Human subjects research at DOE encompasses a variety of studies -- many funded by other agencies in recognition of the expertise and facilities only available at DOE sites. This research encompasses such lifesaving research as non-invasive diagnostic imaging technologies to see into the human body; advanced cancer therapies using radiation and radio-immune therapy; nuclear medicine techniques that allow exploration of fundamental and pathological processes; and development of biomarkers and cellular assays for monitoring and protecting the health of DOE workers and the general public. Studies of de-identified worker records for disease patterns, surveys of occupant comfort in weatherized buildings, security detectors, and studies involving surveys of smokers or runners for health insights are also among the diverse projects that come under the rubric of "human subjects research."
It is important to note that human subjects studies are not done just to test the effects of chemicals or radiation on volunteers. Effects studies just to "see what happens" are not done by DOE or any Federal agency and recent press releases about research conducted many decades ago may have contributed to confusion with regard to the science-based studies and IRB reviewed biomedical research that is currently being conducted. In contemporary studies, radiation or chemicals are only employed where a therapeutic or diagnostic protocol has been approved by a human studies board following scientific peer review.
The Office of Health and Environmental Research within the Office of Energy Research (OHER) has the responsibility for approval and assurance of all human subjects projects conducted at Departmental facilities or with Departmental funds. The research conducted must meet the highest standards of both scientific/technical excellence and bioethical conduct. OHER also implements and oversees both the Departmental and Federal policy for the protection of human subjects within DOE.
In December 1993, when Secretary of Energy O'Leary began her "openness initiative," DOE had well-established oversight for its facilities in relation to current human subject research. These were utilized to finally put "on-line" a publicly available electronic human subjects research project database. Prior to the openness initiative, this data existed only in paper copy. It is widely searched both domestically and abroad. The Fiscal Year 1994 database access information is provided with this report as backup to the testimony. The Fiscal Year 1995 database is now ready to go on-line with all research projects involving humans conducted at DOE sites, or performed with DOE funds or personnel.
DOE proactively undertook a review of its sites by the DOE Health and Environmental Research Advisory Committee (HERAC) as part of the DOE openness initiative. The HERAC reported that DOE had an excellent system in place. HERAC did make some useful suggestions, the majority of which were adopted by DOE. The primary recommendation was for the establishment of a regular system of performance reviews to evaluate human subjects regulatory compliance by DOE at all sites. This review process began last month at four California sites -- three Laboratories and one DOE field office. These reviews are designed to be interactive and educational between the review team and the site and to suggest local improvements or provide guidance on issues not resolved by the 1991 common rule. In summary, a DOE human subjects performance review was undertaken in 1994, and this process will formally continue. Approximately every three years, using outside ethicists, scientists, and laypersons as reviewers, each Laboratory will be revisited. Other details on DOE's activities in current human subject protection can be found in the attached report to NBAC.
In closing, let me focus on the central role of openness in the Clinton Administration. Over the past several decades, the American people's trust in the institutions of government has greatly eroded. Many complex factors have contributed to this erosion, not least among them the secrecy associated with our Cold War nuclear competition with the Soviet Union. Without judging the historical necessity of secrecy, it is a fact that the ability of the government to perform its post-Cold War missions is greatly impeded by pervasive public distrust of its motives and competence.
To help remedy that distrust, we have told the story of human radiation experiments to the best of our ability, even though it required this Administration to disclose historical episodes that are embarrassing, discomforting, or even worse. As part of our commitment to openness in government, we are now fully engaged in an active, forward-looking effort to continue to provide information and services to the public and to ensure that the mistakes of the past will not be repeated.
Thank you. I will be pleased to answer any questions the Committee may have.
Please send comments to support@tis.eh.doe.gov
Last modified: 03/21/96 10:59:28