Book Review

Final Report of the Advisory Committee on Human Radiation Experiments

N Engl J Med 1996; 335:1850-1851December 12, 1996

Article

Final Report of the Advisory Committee on Human Radiation Experiments
620 pp. New York, Oxford University Press, 1996. $39.95. ISBN: 0-19-510792-6

The last time I devoted my summer holiday reading to a single book was when War and Peace was assigned in high school. In addition to bulk, the similarities between the Final Report of the Advisory Committee on Human Radiation Experiments and Tolstoy's classic include a large cast of characters and a more than occasional tone of moral indignation. The action in both takes place in war and peace.

The Final Report is the work of a distinguished panel appointed by President Bill Clinton in 1994, mostly comprising academics in the medical and radiation sciences, law, ethics, and other disciplines and chaired by Ruth Faden, director of the Bioethics Institute at Johns Hopkins University. Some 50 staff members assisted the panel. It reviewed experiments conducted between 1944 and 1974 that involved exposing humans to ionizing radiation from various sources. The experiments, some intentional and some accidental, had a wide range of formats and covered a variety of research topics, medical and nonmedical.

The report begins with a primer on radiation, radioactivity, and effects of radiation and a historical perspective on the ethics of research on human subjects. It proceeds with case studies that I would group in three categories: studies of the health effects of the Manhattan Project, assessments of the psychological and somatic effects of putative nuclear warfare, and clinical investigations involving radionuclides. The panel distinguishes among these categories, but grouping them all under the rubric of “human radiation experiments” has some confounding consequences. In the case of the Manhattan Project and nuclear warfare, the chief concern should be acts committed in the name of national security, with their attendant secrecy; as for clinical investigation, the principal interests are parity in the patient–doctor relationship, experimentation on vulnerable populations, and informed consent.

The book has a central premise, perhaps a dogma — that certain ethical principles are so basic that they are not temporally limited and should have been applied throughout the period under study, independently of evolving standards. These principles are the six “one oughts”: not to treat people as mere means to an end, not to deceive others, not to inflict harm or a risk of harm, to promote welfare and prevent harm, to treat people fairly and with equal respect, and to respect others' right to self-determination. Judged against these six principles, many of the experiments described in the Final Report fail or falter.

Yet, except for the most egregious examples, the authors do not unduly castigate and seem more intent on informing than on scolding. And they provide considerable information, including oddments such as the informed-consent requirements laid down by the Weimar Republic's Ministry of the Interior in 1931 for therapeutic and nontherapeutic medical research and the 1953 top-secret memorandum of Secretary of Defense Charles Wilson, reiterating the Nuremberg Code and requiring that informed consent be written and witnessed. A copy of Wilson's memorandum was sent to the Joint Chiefs of Staff, but initially it was disseminated no lower than the three secretaries of the armed services because of its security classification. Informed consent is the banner held aloft throughout the Final Report and reemphasized by Jay Katz, a panel member who keenly believes that the matter has not been sufficiently addressed in evaluating current behavior. Katz also points out that the dignity of the subjects, rather than physical injury, should be our principal concern in reviewing past practices. Indeed, most instances cited in the Final Report seem to have caused little physical harm.

The panel's staff members themselves conducted two experiments. In the first they examined contemporary proposals for research (using radiation or not) with regard to the level of risk, the degree to which the subjects understood the research, the factors likely to affect their voluntary participation, and the inclusion of those with a limited ability to make decisions. All these were issues in experiments conducted between 1944 and 1974. Among the panel's findings was that research using radiation is not more risky or ethically problematic than research that does not use radiation; actually, research using radiation may be controlled more strictly than other research, because of the double review by institutional review boards and radiation-safety committees. But the panel also found substantial deficiencies in the current system with regard to the protection of human subjects. In the second study by the panel, 1900 patients were interviewed. Among the conclusions was the following:

. . . nearly 40 percent of the patients we talked with either believed they were or had been subjects of research . . . almost all of these patients said they had enrolled in research because they thought it was their best chance of personal medical benefit — [but] many patients also said that they had participated in research to help others.

The panel concludes with 23 findings and 18 recommendations. Some are technical, and others are general and not beyond contention. But whether one agrees with all of them or not, this thick book tells a cautionary tale. The great knowledge of disease processes, powerful diagnostic methods, and useful treatments derived from the radioactive materials that became available after World War II came at a price that with greater wisdom and thoughtfulness might have been avoided.

S. James Adelstein, M.D., Ph.D.
Harvard Medical School, Boston, MA 02115