A platform for research: civil engineering, architecture and urbanism
A platform for research: civil engineering, architecture and urbanism
Results of the Institutional Review Boards Pilot Compliance Program
The study presents the results of a pilot inspection program of institutional review boards (IRBs) conducted in 1977. The pilot program was conducted to give the Agency a profile of present IRB performance and to find out whether proposed IRB regulations, a part of FDA's overall Bio-Research Monitoring Program, are reasonable and attainable. The evaluation of the pilot, using data from field inspections of a randomly selected national sample of 116 IRBs considered three factors: (1) Structure, the scope and level of IRB activities, (2) Compliance in the areas in which regulations have been proposed, and (3) Informed Consent.
Results of the Institutional Review Boards Pilot Compliance Program
The study presents the results of a pilot inspection program of institutional review boards (IRBs) conducted in 1977. The pilot program was conducted to give the Agency a profile of present IRB performance and to find out whether proposed IRB regulations, a part of FDA's overall Bio-Research Monitoring Program, are reasonable and attainable. The evaluation of the pilot, using data from field inspections of a randomly selected national sample of 116 IRBs considered three factors: (1) Structure, the scope and level of IRB activities, (2) Compliance in the areas in which regulations have been proposed, and (3) Informed Consent.
Results of the Institutional Review Boards Pilot Compliance Program
S. P. Reinsch (author)
1979
40 pages
Report
No indication
English
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