RESEARCH NEEDS AND THE RIGHT TO PRIVACY AND CONFIDENTIALITY.

An important challenge in medical and epidemiologic studies is to protect the privacy of human research subjects and the confidentiality of the data they provide and at the same time facilitate the conduct of legitimate research activities which are critical for preventing disease and advancing the health of the community. In epidemiologic investigations medical records are an invaluable source of information. Such records are essential in these investigations and the information they contain must be available in individually identifiable form during the time the study is being carried out. Any requirement that prior patient consent be required before access to medical records is permitted would make most studies impossible. It is also important that redisclosures of information be permitted to legitimate investigators as long as appropriate safeguards are in force. At the present time an elaborate system exists for protecting the privacy and confidentiality of research subjects and their information. Several recommendations are made for further improvement in these safeguards.