Advisory Committee on Human Radiation Experiments FACT SHEET AND QUESTIONS AND ANSWERS The Advisory Committee on Human Radiation Experiments is a 14- member committee of nationally recognized experts in the areas of bioethics, epidemiology, law and nuclear medicine. The Committee also includes a public representative. Appointed by the President in April 1994, the members are to prepare a report, due in April 1995, about the use of human beings as subjects of federally funded research using ionizing radiation. Ruth Faden, Ph.D., M.P.H., a bioethicist at Johns Hopkins University, chairs the Advisory Committee. The Committee's report will be issued to an Interagency Working Group composed of the secretaries of the departments of Defense, Energy, Health and Human Services, Justice, and Veterans Affairs, and the directors of the Central Intelligence Agency and the Office of Management and Budget, and the administrator of the National Aeronautics and Space Administration. The Committee's charter includes the investigation of experiments conducted since 1942 with ionizing radiation, the investigation of specific intentional releases of radiation into the environment, and the recommendation to the working group of remedies for abused of human subjects in past experiments, and of policies to improve ethical practices in today's research. The Committee held its first meeting in April 1994 and has met approximately monthly since. A staff of professionals in history, bioethics, nuclear medicine and epidemiology works in Washington, D. C., under the Committee's direction. The staff is headed by Executive Director Dan Guttman. Stephen Klaidman is spokesman for the Committee and can be reached by telephone at 202/254-9795. The Advisory Committee's meetings are public and material presented to members of the Committee at its meetings become public record. The Committee's schedule includes at least one meeting on the West Coast and also includes meetings of panels to hear testimony at other sites in the United States. -O- -O- -O- -O- -O- QUESTIONS AND ANSWERS Why was the Advisory Committee formed? The President of the United States appointed the Committee to analyze these questions: What is the federal government's responsibility for wrongs and harms to human subjects as a result of experiments with ionizing radiation? What remedies are appropriate for those wronged or harmed? And what lessons learned from studying research standards and practices in the past and present can be applied to the future? Who are members of the Advisory Committee? The 14 members are nationally recognized experts in bioethics, epidemiology, radiation oncology and biology, history of science, law and nuclear medicine. The Committee also includes a citizen representative. Ruth Faden, a bioethicist at Johns Hopkins University, chairs the Advisory Committee. What is the Committee authorized to review? The Committee's charter includes the review of experiments conducted since the 1940s with ionizing radiation and the investigation of specific intentional releases of radiation into the environment. The Committee's mandate does not include common and routine clinical practices, such as established diagnosis and treatment methods. An important question is how to define the difference between ordinary practice and experimental procedures. Another important question is whether accidental exposures gave agencies or researchers a chance to conduct "experiments of opportunity." What will the Advisory Committee do? The members will prepare a report designed to answer the three questions posed above. The report will be issued in 1995 to an Interagency Working Group composed of the secretaries of the departments of Defense, Energy, Health and Human Services, Justice, and Veterans Affairs, and the directors of the Central Intelligence Agency and the Office of Management and Budget, and the administrator of the National Aeronautics and Space Administration. How will the Advisory Committee evaluate today's practices? A sample of research protocols funded by federal agencies in fiscal year 1993 is being used to assess ethical standards and procedures in today's environment. Researchers and subjects of research will be interviewed. How has the Committee looked into past practices? The President directed federal agencies to search their files for information about research on human subjects in the past. This process has been revised and expanded under the Committee's direction. Literally thousands of documents, many previously unreported and some of them only declassified this year, have been made available to the public as a result of this effort. Many documents are, of course, fragmentary accounts of experiments. Recreating the ethics policies, standards and practices of 40 or 50 years ago is difficult, much less recreating the conversations between subjects and researchers. The Advisory Committee has reviewed many private collections left by subjects of experiments and by researchers. How has the Committee responded to public concern about these experiments? The Committee recognizes the importance of hearing directly from people throughout the country and including them in its activities. The Committee seeks out participants in past experiments to hear about their experiences and use their recollections to guide its research and inform its judgments. In addition to soliciting the views of subjects and other interested parties at its Washington meetings, the Committee has scheduled public meetings around the country to hear first-hand from persons involved in research. The Committee has gained valuable documents and insights from working with subjects or their families, as well as researchers, and that process will continue throughout the life of the Committee's work. What are key questions about experimentation? The Committee must define the boundaries of experimentation. What is an experiment? How does it differ from innovative treatment? How does it differ from training, as in the case of military units participating in atomic weapons tests in the 1950s? When is an experiment over? Each question bears on the scope of the Committee's endeavors and the way it evaluates the evidence before it. What are the ethical questions in research? The issues to be weighed by the Committee are many and complex. These include the risks or harm to the subject, and the benefit to the subject or to society as a whole; whether subject populations have been chosen fairly and appropriately; whether subjects have been fully informed and have fully consented to participate in research. The Committee has discovered more extensive ethical codes and policies in the government than had previously been known. It's not always clear whether they were applied, or how they were interpreted in different circumstances. These codes and policies, however, are critical to the determination of whether experiment subjects were appropriately informed of risks or harms, and selected fairly for the purposes of experimentation. How can people contact the Committee? The Committee staff can be reached by telephone at 202/254- 9795 or in writing at 1726 M Street NW, Suite 600, Washington, D.C. 20036.