On behalf of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Biennial Report on "Protecting Human Subjects." The Commission is directed by $1802 (c) of the Public Health Service Act to report every two years on the adequacy and uniformity of the Federal rules and policies, and their implementation, for the protection of human subjects in biomedical and behavioral research. As the Commission began its work in January 1980, this is our first Biennial Report. The Commission does not propose any major changes in the substance of the rules on human research, although a number of adjustments are recommended to recognize the flexibility needed by research institutions, particularly in responding to allegations of wrongdoing or other problems. We also propose a simple improvement in the reports filed by researchers, to provide information on the number of subjects and on any that are adversely affected by participation in a research project. The Commission does recommend one major organizational change, namely that a uniform core of regulations be adopted, based upon the present rules of the Department of Health and Human Services, and that HHS become the lead agency in this field. This consolidation would eliminate needless duplication in the rules of the 23 other Federal entities that support or regulate research, thereby simplifying both local compliance with the rules and Federal oversight of the system. Copies of this report are being sent to all affected Federal agencies, with a request for action, pursuant to the Commission's enabling legislation. We are continuing to examine the important subject of human research and may have further recommendations in our next report on this subject. Respectfully, Maus Morris B. Abram President's Commission for the Study of Ethical Problems Suite 555, 2000 K Street, N.W., Washington, DC 20006 (202) 653-8051 December 30, 1981 The Honorable Thomas P. O'Neill, Jr. Speaker U.S. House of Representatives Washington, D.C. 20515 Dear Mr. Speaker: On behalf of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Biennial Report on "Protecting Human Subjects." The Commission is directed by $1802 (c) of the Public Health Service Act to report every two years on the adequacy and uniformity of the Federal rules and policies, and their implementation, for the protection of human subjects in biomedical and behavioral research. As the Commission began its work in January 1980, this is our first Biennial Report. The Commission does not propose any major changes in the substance of the rules on human research, although a number of adjustments are recommended to recognize the flexibility needed by research institutions, particularly in responding to allegations of wrongdoing or other problems. We also propose a simple improvement in the reports filed by researchers, to provide information on the number of subjects and on any that are adversely affected by participation in a research project. The Commission does recommend one major organizational change, namely that a uniform core of regulations be adopted, based upon the present rules of the Department of Health and Human Services, and that HHS become the lead agency in this field. This consolidation would eliminate needless duplication in the rules of the 23 other Federal entities that support or regulate research, thereby simplifying both local compliance with the rules and Federal oversight of the system. Copies of this report are being sent to all affected Federal agencies, with a request for action, pursuant to the Commission's enabling legislation. We are continuing to examine the important subject of human research and may have further recommendations in our next report on this subject. Agencies Included in the National Commission Report that are not Reviewed in this Report The Regulatory System Governing Research Conducted 21 53 53 |