EVALUATION OF NIH IMPLEMENTATION OF SECTION 491

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The objective of this project will be to assess the present program in a comprehensive way. This project is intended to address the following six questions: Questions 1: Does the Human Subjects Protection Program in its current design and operation fulfill its original intent which was to protect adequately the rights and welfare of humans involved in biomedical and behavioral research? Questions 2: Is there credible evidence of a change from findings of past studies in knowledge, attitudes and behavior among research investigators regarding the protection of the rights of human subjects which can be attributed to the program introduced in 1981? Question 3: Are there specific features in the current design of the program, which, if corrected, would be likely to improve the performance of the program, either by reducing its cost and burden, or reducing the likelihood of serious problems occurring? Question 4: What methods and procedures, including changes stemming from the recommendation of the earlier commissions, have been adopted which appear to be capable of improving the adequacy and efficiency of the process of obtaining and documenting informed consent of subject? Question 5: Are there IRB oversight methods which appear to be especially effective in meeting the objectives of the Program? Question 6: In what area of the program, does action by the Government appear to be needed to improve performance? Answers to these questions will be provided to : 1) Federal policy makers; 2) the Federal managers of the system and of related government supported research activities; 3) the performers of research, including both research investigators and the institutional officials charged with accountability for implementing the program. The information is needed to ensure the soundness of the program and to recommend program revisions in the light of evidence on performance.