"The information that is available indicates that the physical harm from the radiation is probably less than the damage - to individuals, communities, and the government - caused by the initial secrecy, however well motivated, and by subsequent failures to deal honestly with the public thereafter."
-- Advisory Committee on Human Radiation Experiments
After a year and a half of intensive investigating, collecting hundreds of thousands of pages of records, holding public hearings and private interviews, the Advisory Committee on Human Radiation Experiments has released its final report. The huge 925-page volume provides an unprecedented, in-depth review and analysis of past radiation research on human subjects in the context of the ethical standards and policy guidelines of the times. It also includes a review of current policies, and recommendations on how to compensate victims of past abuses as well as to ensure that no similar abuses occur in the future.
The Committee was formed by President Clinton in January 1994,after the end of the Cold War and press coverage of radiation experiments prompted Energy Secretary Hazel O'Leary to decide that the history should be made public. The President met with committee members at the first meeting on April 21, 1994. According to the report, he urged them to "tell the full story to the American public," and to "ensure that whatever wrongdoing may have occurred in the past cannot be repeated." The 14-member Committee is composed of experts in various aspects of medicine, health, ethics, history and law, and a citizen representative. It was charged with reviewing the history of government-sponsored human radiation experiments and intentional radiation releases between 1944 and 1974, and determining "the ethical and scientific standards by which to evaluate" them. The committee was also authorized to examine samples of current research on human subjects.
The committee reports that it "had to collect information scattered in warehouses throughout the country... [and] create and test the framework needed to ensure that there would be a 'big picture' into which all the pieces of the puzzle would fit." Although many records had inevitably been lost or destroyed, the document commends the cabinet-level Human Radiation Interagency Working Group - comprised of the secretaries of defense, energy, HHS, VA, and other government officials - for their efforts at making federal records available.
The report follows the government's history of human radiation experiments, beginning with Second World War and Cold War-era concerns about preparing for and surviving an atomic war. The Committee was able to trace, from existing documents, the evolution of ethical standards for human-subject research over the time period studied. An important benchmark in scientific ethics was the 1947 development of the Nuremberg Code as a standard by which to judge Nazi researchers. The committee found that the concept of informed consent from subjects was commonly used in human experimentation prior to that, going back to the turn-of-the-century use of military volunteers in Yellow Fever research. A number of government agencies and officials, in particular the Atomic Energy Commission (AEC), held discussions and formulated statements about the need for informed consent in radiation experiments, but these guidelines, the report says, were often not made public or effectively disseminated to theexperimenters who needed them. Policies for use of radiation on sick patients and vulnerable populations were less clear-cut and slower to evolve, according to the report. In the case of sick subjects in particular, the report finds that issues of doctor-patient confidence and the possibility of potential benefits clouded the ethics issue.
It was only in 1974, the endpoint of the committee's study, that the Department of Health, Education and Welfare adopted a comprehensive set of regulations for all human-subject research, and not until 1991 that the regulations were instituted government-wide.
Over the 30-year period, the committee reports that the government sponsored, through several different agencies, thousands of human radiation experiments and several hundred intentional releases of radiation. The committee found that the majority of experiments were radioactive tracer studies that were "unlikely to have caused physical harm," and asserts that overall, "the legacy of distrust...is probably more significant than the legacy of physical harm." In some cases, the committee holds the government and government officials responsible for failure to disseminate and implement their own policies. In other instances, it charges that individual researchers were responsible when they did not comply with the accepted standards of professional ethics at the time. With respect to experiments most closely related to national security, the committee says, "it does not appear that such considerations would have barred satisfying the basic elements of voluntary consent."
To the question of whether similar abuses could occur again,particularly in the case of intentional releases, the committee gives "a qualified yes." It notes that some agencies can still invoke national security considerations to waive consent requirements, that agencies are often responsible for their own oversight, and that environmental impact statements relating to classified projects are not available for public scrutiny. The report recommends numerous changes to current federal policies; most significantly, it calls for elimination of all exemptions from informed consent requirements.
On the subject of compensation, the committee suggests that the government provide a personal, individualized apology to those people used as research subjects without their knowledge, or to surviving family members. If physical harm resulted, or if the government deliberately attempted to conceal their participation to avoid liability or embarrassment, the committee recommends that the government also provide financial compensation.
A copy of the report, with additional materials, will be available on Internet at http://www.seas.gwu.edu/nsarchive/radiation. The report may also be purchased from the Superintendent of Documents,GPO, at (202)512-1800; fax (202)512-2250.
In response to many of the concerns indicated by the committee, on October 3 President Clinton announced that a National Bioethics Advisory Commission will be established by executive order. All federal agencies involved in human-subject research are ordered to review their policies for such research, taking "account of the recommendations contained in the report of the Advisory Committee on Human Radiation Experiments," and report within 120 days to the Bioethics Commission.