Obtaining Access to Data from Government-Sponsored Medical Research

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