Obtaining Access to Data from Government-Sponsored Medical Research

Abstract

Considerations of confidentiality often conflict with the needs of\npublic health and regulatory agencies, as well as those of product liability\nlitigants and of public interest groups, for access to research results from\ngovernment-sponsored studies. The authors discuss recent litigation over\naccess to epidemiologic data on the link between aspirin and Reye's syndrome\nas an example of the inconsistent legal standards that are being applied by\ncourts in such cases. They recommend that data should be shared with all\ninterested parties whenever government-sponsored studies may result in new\ngovernment regulations or health policies, and that procedures to protect the\nprivacy of research subjects should be built into the research protocols. (KIE\nabstract)