Protection of human subjects of biomedical and behavioral research.

pleased to transmit our report and recommendations concerning the use of psychosurgery. This is one of several areas which Public Law 93-348 directs the Commission to study; we are further directed to make recommendations for appropriate action to the Congress and the Secretary of the Department of Health, Education, and Welfare, and to issue reports periodically to the President, the Congress and the Secretary. In response to this section of our mandate, the Commission has sought to develop as much information about psychosurgery as was possible during the time allowed. We have been mindful of the public concern in this area, as well as the hesitancy of courts and legislatures to authorize performance or unrestricted use of psychosurgery. On the basis of data from pilot studies that were conducted under contract to assess the effects of psy-chosurgery, the Commission has determined unanimously that there are circumstances under which psychosurgical procedures may appropriately be performed. The Commission has developed a set of requirements that will protect the access of individuals to a potential therapy, while recognizing the responsibility of the state to protect individual rights and safety. Although one member of the Commission has dissented from certain recommendations, the reservations concern only certain highly vulnerable patient populations, and our conclusion that psychosurgery should not be prohibited categorically was unanimous. The Commission's report includes comments reflecting its deliberations, and a summary of the information on which those deliberations were based. The full reports of the contracted studies that were conducted for the Commission are included in an appendix volume. These appendix papers constitute the most extensive evaluation of modern psychosurgical procedures that is currently available. We are grateful for the opportunity to assist in resolving this issue of public concern. INTRODUCTION In response to widespread public concern, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was directed to investigate and to recommend policies that should govern the use of psychosurgery. Specifically, the Commission's mandate under section 202(c) of the National Research Act (P.L. 93-348) requires that: The Commission shall conduct an investigation and study of the use of psychosurgery in the United States during the five-year period ending December 31, 1972. The Commission shall determine the appropriateness of its use, evaluate the need for it, and recommend to the Secretary policies defining the circumstances (if any) under which its use may be appropriate. For purposes of …