ERIC Number: ED201677
Record Type: RIE
Publication Date: 1980-Mar
Reference Count: 0
Issues in Research with Human Subjects. A Symposium (National Institutes of Health, Bethesda, Maryland, March 20-21, 1981).
Health Services and Mental Health Administration (DHEW), Bethesda, MD.
This conference was designed to facilitate an exchange of information and experiences on the major issues in research with human subjects. In each session, a speaker from the United States and one from the United Kingdom reviewed procedures, progress, and problems related to a particular topic, leading to a thorough discussion of the advantages or disadvantages of the systems being compared. Each presentation thus provided a significant review of the topic under discussion. The following topics were presented: (1) Inititating Large-Scale Clinical Trials; (2) Randomized Controlled Trials in Health Services Research; (3) Problems of Long-Term Recordkeeping; (4) Compensation of Research Subjects for Adverse Effects; (5) Clinical Research on Children; (6) Role of the Public in Monitoring Research with Human Subjects; (7) Relationship Between Government and Industry in Clincal Trials; (8) International Standards in Clinical Research; and (9) Acceptance of Foreign Data by the Food and Drug Administration. Participants agreed that many benefits would result from the establishment of international standards for clinical research, not the least of which would be the possibility of objective and realistic comparison of data developed in either country and a simplification of procedures involved in licensing new products. (RL)
Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
Publication Type: Collected Works - Proceedings
Education Level: N/A
Authoring Institution: Health Services and Mental Health Administration (DHEW), Bethesda, MD.
Identifiers: Human Subject Protection; United Kingdom; United States