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July 27, 2011

Health Research and the HIPAA Privacy Rule

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2008;299(11):1259-1260. doi:10.1001/jama.299.11.1259-b

To the Editor: We are concerned about possible misinterpretation of information in the Editorial by Drs Fost and Levine1 regarding the Advisory Committee on Human Radiation Experiments (ACHRE). They wrote, “In 1995 a committee appointed by President Clinton [ACHRE] reported on widespread studies involving administration of or exposure to radiation. In some studies the doses of radiation exposure were toxic, and among the subjects were children, pregnant women, and patients with lethal diseases; some of these studies would have been considered egregiously unethical by contemporary standards. All of these studies occurred before 1974, the year in which the Department of Health, Education and Welfare first promulgated regulations for the protection of human research subjects. Nonetheless, President Clinton linked the report with the creation of a wider inquiry into the adequacy of protection of human research participants.”