DOE Openness: Human Radiation Experiments: Roadmap to the Project
Advisory Committee on Human Radiation Experiments - Executive Summary
The Creation of the Advisory Committee
The President's Charge
The Committee's Approach
The Historical Context
What's Next: The Advisory Committee's Legacy
The Final Report of the Advisory Committee on Human Radiation Experiments (stock number 061-000-00-848-9), the supplemental volumes to the Final Report (stock numbers 061-000-00850-1, 061-000-00851-9, and 061-000-00852-7), and additional copies of this Executive Summary (stock number 061-000-00849-7) may be purchased from the Superintendent of Documents, U.S. Government Printing Office.
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An Internet site containing ACHRE information (replicating the Advisory Committee's original gopher) will be available at George Washington University. The site contains complete records of Advisory Committee actions as approved; complete descriptions of the primary research materials discovered and analyzed; complete descriptions of the print and non-print secondary resources used by the Advisory Committee; a copy of the Interim Report of October 21, 1994, and other information. The address is http://www.gwu.edu/~nsarchiv/radiation/. The site will be maintained by the National Security Archive at GWU.
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THE CREATION OF THE ADVISORY COMMITTEE
On January 15, 1994, President Clinton appointed the Advisory Committee on Human Radiation Experiments. The President created the Committee to investigate reports of possibly unethical experiments funded by the government decades ago.
The members of the Advisory Committee were fourteen private citizens from around the country: a representative of the general public and thirteen experts in bioethics, radiation oncology and biology, nuclear medicine, epidemiology and biostatistics, public health, history of science and medicine, and law.
President Clinton asked us to deliver our recommendations to a Cabinet-level group, the Human Radiation Interagency Working Group, whose members are the Secretaries of Defense, Energy, Health and Human Services, and Veterans Affairs; the Attorney General; the Administrator of the National Aeronautics and Space Administration; the Director of Central Intelligence; and the Director of the Office of Management and Budget. Some of the experiments the Committee was asked to investigate, and particu larly a series that included the injection of plutonium into unsus pecting hospital patients, were of special concern to Secretary of Energy Hazel O'Leary. Her department had its origins in the federal agencies that had sponsored the plutonium experiments. These agencies were responsible for the development of nuclear weapons and during the Cold War their activities had been shrouded in secrecy. But now the Cold War was over.
The controversy surrounding the plutonium experiments and others like them brought basic questions to the fore: How many experiments were conducted or sponsored by the government, and why? How many were secret? Was anyone harmed? What was disclosed to those subjected to risk, and what opportunity did they have for consent? By what rules should the past be judged? What remedies are due those who were wronged or harmed by the government in the past? How well do federal rules that today govern human experimentation work? What lessons can be learned for application to the future? Our Final Report provides the details of the Committee's answers to these questions. This Executive Summary presents an overview of the work done by the Commit tee, our findings and recommendations, and the contents of the Final Report.
THE PRESIDENT'S CHARGE
The President directed the Advisory Committee to uncover the history of human radiation experiments during the period 1944 through 1974. It was in 1944 that the first known human radiation experiment of interest was planned, and in 1974 that the Depart ment of Health, Education and Welfare adopted regulations governing the conduct of human research, a watershed event in the history of federal protections for human subjects.
In addition to asking us to investigate human radiation experi ments, the President directed us to examine cases in which the government had intentionally released radiation into the environ ment for research purposes. He further charged us with identifying the ethical and scientific standards for evaluating these events, and with making recommendations to ensure that whatever wrongdoing may have occurred in the past cannot be repeated.
We were asked to address human experiments and intentional releases that involved radiation. The ethical issues we addressed and the moral framework we developed are, however, applicable to all research involving human subjects.
The breadth of the Committee's charge was remarkable. We were called on to review government programs that spanned administrations from Franklin Roosevelt to Gerald Ford. As an independent advisory committee, we were free to pursue our charge as we saw fit. The decisions we reached regarding the course of our inquiry and the nature of our findings and recommen dations were entirely our own.
THE COMMITTEE'S APPROACH
At our first meeting, we immediately realized that we were embarking on an intense and challenging investigation of an important aspect of our nation's past and present, a task that required new insights and difficult judgments about ethical ques tions that persist even today.
Between April 1994 and July 1995, the Advisory Committee held sixteen public meetings, most in Washington, D.C. In addition, subsets of Committee members presided over public forums in cities throughout the country. The Committee heard from more than 200 witnesses and interviewed dozens of profes sionals who were familiar with experiments involving radiation. A special effort, called the Ethics Oral History Project, was under taken to learn from eminent physicians about how research with human subjects was conducted in the l940s and 1950s.
We were granted unprecedented access to government documents. The President directed all the federal agencies involved to make available to the Committee any documents that might further our inquiry, wherever they might be located and whether or not they were still secret.
As we began our search into the past, we quickly discovered that it was going to be extremely difficult to piece together a coherent picture. Many critical documents had long since been forgotten and were stored in obscure locations throughout the country. Often they were buried in collections that bore no obvious connection to human radiation experiments. There was no easy way to identify how many experiments had been conducted, where they took place, and which government agencies had sponsored them. Nor was there a quick way to learn what rules applied to these experiments for the period prior to the mid-1960s. With the assistance of hundreds of federal officials and agency staff, the Committee retrieved and reviewed hundreds of thousands of government documents. Some of the most important documents were secret and were declassified at our request. Even after this extraordinary effort, the historical record remains incomplete. Some potentially important collections could not be located and were evidently lost or destroyed years ago.
Nevertheless, the documents that were recovered enabled us to identify nearly 4,000 human radiation experiments sponsored by the federal government between 1944 and 1974. In the great majority of cases, only fragmentary data was locatable; the identity of subjects and the specific radiation exposures involved were typically unavailable. Given the constraints of information, even more so than time, it was impossible for the Committee to review all these experiments, nor could we evaluate the experiences of countless individual subjects. We thus decided to focus our investigation on representative case studies reflecting eight different categories of experiments that together addressed our charge and priorities. These case studies included:
In addition to assessing the ethics of human radiation experi ments conducted decades ago, it was also important to explore the current conduct of human radiation research. Insofar as wrongdo ing may have occurred in the past, we needed to examine the likelihood that such things could happen today. We therefore undertook three projects:
THE HISTORICAL CONTEXT
Since its discovery 100 years ago, radioactivity has been a basic tool of medical research and diagnosis. In addition to the many uses of the x ray, it was soon discovered that radiation could be used to treat cancer and that the introduction of "tracer" amounts of radioisotopes into the human body could help to diagnose disease and understand bodily processes. At the same time, the perils of overexposure to radiation were becoming apparent.
During World War II the new field of radiation science was at the center of one of the most ambitious and secret research efforts the world has known--the Manhattan Project. Human radiation experiments were undertaken in secret to help under stand radiation risks to workers engaged in the development of the atomic bomb.
Following the war, the new Atomic Energy Commission used facilities built to make the atomic bomb to produce radioisotopes for medical research and other peacetime uses. This highly publicized program provided the radioisotopes that were used in thousands of human experiments conducted in research facilities throughout the country and the world. This research, in turn, was part of a larger postwar transformation of biomedical research through the infusion of substantial government monies and technical support.
The intersection of government and biomedical research brought with it new roles and new ethical questions for medical researchers. Many of these researchers were also physicians who operated within a tradition of medical ethics that enjoined them to put the interests of their patients first. When the doctor also was a researcher, however, the potential for conflict emerged between the advancement of science and the advancement of the patient's wellbeing.
Other ethical issues were posed as medical researchers were called on by government officials to play new roles in the develop ment and testing of nuclear weapons. For example, as advisers they were asked to provide human research data that could reassure officials about the effects of radiation, but as scientists they were not always convinced that human research could provide scientifi cally useful data. Similarly, as scientists, they came from a tradition in which research results were freely debated. In their capacity as advisers to and officials of the government, however, these researchers found that the openness of science now needed to be constrained.
None of these tensions were unique to radiation research. Radiation represents just one of several examples of the exploration of the weapons potential of new scientific discoveries during and after World War II. Similarly, the tensions between clinical research and the treatment of patients were emerging throughout medical science, and were not found only in research involving radiation. Not only were these issues not unique to radiation, but they were not unique to the 1940s and 1950s. Today society still struggles with conflicts between the openness of science and the preservation of national security, as well as with conflicts between the advancement of medical science and the rights and interests of patients.
Human Radiation Experiments
Secrecy and the Public Trust
Contemporary Human Subjects Research
Current Regulations on Secrecy in Human Research and Environmental Releases
The Committee's complete findings, including findings regarding experiments conducted in conjunction with atmospheric atomic testing and other population exposures, appear in chapter 17 of the Final Report.
Apologies and Compensation
The government should deliver a personal, individualized apology and provide financial compensation to those subjects of human radiation experiments, or their next of kin, in cases where:
Improved Protection for Human Subjects
Secrecy: Balancing National Security and the Public Trust
Current policies do not adequately safeguard against the recurrence of the kinds of events we studied that fostered distrust. The Advisory Committee concludes that there may be special circumstances in which it may be necessary to conduct human research or intentional releases in secret. However, to the extent that the government conducts such activities with elements of secrecy, special protections of the rights and interests of individuals and the public are needed.
Research involving human subjects. The Advisory Committee recommends the adoption of federal policies requiring:
Environmental releases. There must be independent review to assure that the action is needed, that risk is minimized, and that records will be kept to assure a proper accounting to the public at the earliest date consistent with legitimate national security con cerns. Specifically, the Committee recommends that:
The Committee's complete recommendations, including recommendations regarding experiments conducted in conjunction with atmospheric atomic testing and other population exposures, appear in chapter 18 of the Final Report.
WHAT'S NEXT: THE ADVISORY COMMITTEE'S LEGACY
Interagency Working Group Review
The Interagency Working Group will review our findings and recommendations and determine the next steps to be taken.
Continued Public Right To Know
The complete records assembled by the Committee are available to the public through the National Archives. Citizens wishing to know about experiments in which they, or family members, may have taken part, will have continued access to the Committee's database of 4,000 experiments, as well as the hundreds of thousands of further documents assembled by the Committee. The Final Report contains "A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them." This guide explains how to find federal records, how to obtain information and services from the member agencies of the Interagency Working Group and the Nuclear Regulatory Commission, how to locate personal medical records, and how to use the Advisory Committee's collection.
Supplemental volumes to the Final Report contain supporting documents and background material as well as an exhaustive index to sources and documentation. These volumes should prove useful to citizens, scholars, and others interested in pursuing the many dimensions of this history that we could not fully explore.