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ACHRE Report

Final Report

Executive Summary

Preface

Introduction

Part I

Part II

Part III

Discussion: Part III

Part IV

Advisory Committee on Human Radiation Experiments - Executive Summary

Publication Information

The Creation of the Advisory Committee

The President's Charge

The Committee's Approach

The Historical Context

Key Findings

Key Recommendations

What's Next: The Advisory Committee's Legacy


PUBLICATION INFORMATION

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.

All telephone orders should be directed to:

Superintendent of Documents
U.S. Government Printing Office
Washington, D.C. 20402
(202) 512-1800
FAX (202) 512-2250
8 a.m. to 4 p.m., Eastern time, M-F

All mail orders should be directed to:


U.S. Government Printing Office
P.O. Box 37l954
Pittsburgh, PA 15250-7954

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.seas.gwu.edu/nsarchive/radiation. The site will be maintained by the National Security Archive at GWU.

Printed in the United States of America


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:

  • experiments with plutonium and other atomic bomb materials
  • the Atomic Energy Commission's program of radioisotope distribution
  • nontherapeutic research on children
  • total body irradiation
  • research on prisoners
  • human experimentation in connection with nuclear weapons testing
  • intentional environmental releases of radiation
  • observational research involving uranium miners and residents of the Marshall Islands

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:

  • A review of how each agency of the federal government that currently conducts or funds research involving human subjects regulates this activity and oversees it.
  • An examination of the documents and consent forms of research projects that are today sponsored by the federal government in order to develop insight into the current status of protections for the rights and interests of human subjects.
  • Interviews of nearly 1,900 patients receiving out-patient medical care in private hospitals and federal facilities throughout the country. We asked them whether they were currently, or had been, subjects of research, and why they had agreed to participate in research or had refused.

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.


KEY FINDINGS

Human Radiation Experiments

  • Between 1944 and 1974 the federal government sponsored several thousand human radiation experiments. In the great majority of cases, the experiments were conducted to advance biomedical science; some experiments were conducted to advance national interests in defense or space exploration; and some experiments served both biomedical and defense or space exploration purposes. As noted, in the great majority of cases only fragmentary data are available.

  • The majority of human radiation experiments identified by the Advisory Committee involved radioactive tracers administered in amounts that are likely to be similar to those used in research today. Most of these tracer studies involved adult subjects and are unlikely to have caused physical harm. However, in some nontherapeutic tracer studies involving children, radioisotope exposures were associated with increases in the potential lifetime risk for developing thyroid cancer that would be considered unacceptable today. The Advisory Committee also identified several studies in which patients died soon after receiving external radiation or radioisotope doses in the therapeutic range that were associated with acute radiation effects.

  • Although the AEC, the Defense Department and the National Institutes of Health recognized at an early date that research should proceed only with the consent of the human subject, there is little evidence of rules or practices of consent except in research with healthy subjects. It was commonplace during the 1940s and 1950s for physicians to use patients as subjects of research without their awareness or consent. By contrast, the government and its researchers focused with substantial success on the minimization of risk in the conduct of experi ments, particularly with respect to research involving radioiso topes. But little attention was paid during this period to issues of fairness in the selection of subjects.

  • Government officials and investigators are blameworthy for not having had policies and practices in place to protect the rights and interests of human subjects who were used in research from which the subjects could not possibly derive direct medical benefit. To the extent that there was reason to believe that research might provide a direct medical benefit to subjects, government officials and biomedical professionals are less blameworthy for not having had such protections and practices in place

Intentional Releases

  • During the 1944-1974 period, the government conducted several hundred intentional releases of radiation into the environment for research purposes. Generally, these releases were not conducted for the purpose of studying the effects of radiation on humans. Instead they were usually conducted to test the operation of weapons, the safety of equipment, or the dispersal of radiation into the environment.

  • For those intentional releases where dose reconstructions have been undertaken, it is unlikely that members of the public were directly harmed solely as a consequence of these tests. However, these releases were conducted in secret and despite continued requests from the public that stretch back well over a decade, some information about them was made public only during the life of the Advisory Committee.

Uranium Miners

  • As a consequence of exposure to radon and its daughter products in underground uranium mines, at least several hundred miners died of lung cancer and surviving miners remain at elevated risk. These men, who were the subject of government study as they mined uranium for use in weapons manufacturing, were subject to radon exposures well in excess of levels known to be hazardous. The government failed to act to require the reduction of the hazard by ventilating the mines, and it failed to adequately warn the miners of the hazard to which they were being exposed.

Secrecy and the Public Trust

  • The greatest harm from past experiments and intentional releases may be the legacy of distrust they created. Hundreds of intentional releases took place in secret, and remained secret for decades. Important discussion of the policies to govern human experimentation also took place in secret. Information about human experiments was kept secret out of concern for embarrassment to the government, potential legal liability, and worry that public misunderstanding would jeopardize govern ment programs.

  • In a few instances, people used as experimental subjects and their families were denied the opportunity to pursue redress for possible wrongdoing because of actions taken by the government to keep the truth from them. Where programs were legitimately kept secret for national security reasons, the government often did not create or maintain adequate records, thereby preventing the public, and those most at risk, from learning the facts in a timely and complete fashion.

Contemporary Human Subjects Research

  • Human research involving radioisotopes is currently subjected to more safeguards and levels of review than most other areas of research involving human subjects. There are no apparent differences between the treatment of human subjects of radiation research and human subjects of other biomedical research.

  • Based on the Advisory Committee's review, it appears that much of human subjects research poses only minimal risk of harm to subjects. In our review of research documents that bear on human subjects issues, we found no problems or only minor problems in most of the minimal-risk studies we examined.

  • Our review of documents identified examples of complicated, higher-risk studies in which human subjects issues were carefully and adequately addressed and that included excellent consent forms. In our interview project, there was little evidence that patient-subjects felt coerced or pressured by investigators to participate in research. We interviewed patients who had declined offers to become research subjects, reinforcing the impression that there are often contexts in which potential research subjects have a genuine choice.

  • At the same time, however, we also found evidence suggesting serious deficiencies in aspects of the current system for the protection of the rights and interests of human subjects. For example, consent forms do not always provide adequate information and may be misleading about the impact of research participation on people's lives. Some patients with serious illnesses appear to have unrealistic expectations about the benefits of being subjects in research.

Current Regulations on Secrecy in Human Research and Environmental Releases

  • Human research can still be conducted in secret today, and under some conditions informed consent in secret research can be waived.

  • Events that raise the same concerns as the intentional releases in the Committee's charter could take place in secret today under current environmental laws.

Other Findings

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.


KEY RECOMMENDATIONS

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:

  • efforts were made by the government to keep information secret from these individuals or their families, or the public, for the purpose of avoiding embarrassment or potential legal liability, and where this secrecy had the effect of denying individuals the opportunity to pursue potential grievances.

  • there was no prospect of direct medical benefit to the subjects, or interventions considered controversial at the time were presented as standard practice, and physical injury attributable to the experiment resulted.

Uranium Miners

  • The Interagency Working Group, together with Congress, should give serious consideration to amending the provisions of the Radiation Exposure Compensation Act of 1990 relating to uranium miners in order to provide compensation to all miners who develop lung cancer after some minimal duration of employment underground (such as one year), without requiring a specific level of exposure. The act should also be reviewed to determine whether the documentation standards for compensation should be liberalized.

Improved Protection for Human Subjects

  • The Committee found no differences between human radiation research and other areas of research with respect to human subjects issues, either in the past or the present. In comparison to the practices and policies of the 1940s and 1950s, there have been significant advances in the federal government's system for the protection of the rights and interests of human subjects. But deficiencies remain. Efforts should be under taken on a national scale to ensure the centrality of ethics in the conduct of scientists whose research involves human subjects.

  • One problem in need of immediate attention by the government and the biomedical research community is unrealistic expectations among some patients with serious illnesses about the prospect of direct medical benefit from participating in research. Also, among the consent forms we reviewed, some appear to be overly optimistic in portraying the likely benefits of research, to inadequately explain the impact of research procedures on quality of life and personal finances, and to be incomprehensible to lay people.

  • A mechanism should be established to provide for continuing interpretation and application in an open and public forum of ethics rules and principles for the conduct of human subjects research. Three examples of policy issues in need of public resolution that the Advisory Committee confronted in our work are: (1) Clarification of the meaning of minimal risk in research with healthy children; (2) regulations to cover the conduct of research with institutionalized children; and (3) guidelines for research with adults of questionable competence, particularly for research in which subjects are placed at more than minimal risk but are offered no prospect of direct medical benefit.

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:

  • the informed consent of all human subjects of classified research. This requirement should not be subject to exemption or waiver.

  • that classified research involving human subjects be permitted only after the review and approval of an independent panel of appropriate nongovernmental experts and citizen representa tives, all with the necessary security clearances.

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:

  • Secret environmental releases of hazardous substances should be permitted only after the review and approval of an inde pendent panel. This panel should consist of appropriate, nongovernmental experts and citizen representatives, all with the necessary security clearances.

  • An appropriate government agency, such as the Environmental Protection Agency, should maintain a program directed at the oversight of classified programs, with suitably cleared personnel.

Other Recommendations

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.

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