The Office for Protection from Research Risks (OPRR) fulfills responsibilities set forth in the Public Health Service Act. These include: (1) Developing and monitoring, as well as exercising compliance oversight relative to: (a) HHS Regulations conducted or supported by any component of the Department of Health and Human Services; and (b) PHS Policy on Humane Care and Use of Laboratory Animals involved in research conducted or supported by any component of the Public Health Service; (2) coordinating appropriate HHS regulations, policies, and procedures both within HHS and in coordination with other Departments and Agencies in the Federal Government; and establishing criteria for and negotiation of Assurances of Compliance with institutions engaged in HHS-conducted or supported research involving human subjects and those engaged in PHS- conducted or supported research using animals; (3) conducting programs of clarification and guidance for both the Federal and non-Federal sectors with respect to the involvement of humans and the use of animals in research; and directing the development and implementation of educational and instructional programs and generating educational resource materials; (4) evaluating the effectiveness of HHS policies and programs for the protection of human subjects and the humane care and use of laboratory animals; and (5) serving as liaison to Presidential, Departmental, Congressional, interagency, and non-governmental Commissions and Boards established to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues.

RESEARCH