Obtaining Access to Data From Government-Sponsored Medical Research
Yolles, Bryan Jay
Connors, Joseph C.
New England Journal of Medicine. 1986 Dec 25; 315(26): 1669-1672.
Considerations of confidentiality often conflict with the needs of public health and regulatory agencies, as well as those of product liability litigants and of public interest groups, for access to research results from government-sponsored studies. The authors discuss recent litigation over access to epidemiologic data on the link between aspirin and Reye's syndrome as an example of the inconsistent legal standards that are being applied by courts in such cases. They recommend that data should be shared with all interested parties whenever government-sponsored studies may result in new government regulations or health policies, and that procedures to protect the privacy of research subjects should be built into the research protocols. (KIE abstract)
Biomedical Research; Confidentiality; Consent Forms; Consent; Drugs; Epidemiology; Federal Government; Financial Support; Forms; Freedom; Government; Government Financing; Government Regulation; Health; Human Experimentation; Industry; Information Dissemination; Informed Consent; Injuries; Investigators; Legal Liability; Liability; Medical Research; Privacy; Public Health; Public Policy; Records; Regulation; Research; Research Design; Research Subjects; Standards;
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Reingold, Arthur L.; Broome, Claire V.; Mortimer, Edward A.; Yolles, Bryan Jay; Connors, Joseph C.; Grufferman, Seymour (1987-07-02)