The trusted source for
healthcare information and
1. Developing and monitoring as well as exercising compliance oversight relative to the Department of Health and Human Services (HHS) regulations for the protection of human subjects in research conducted or supported by any component of HHS.
2. Coordinating appropriate HHS regulations, policies, and procedures both within HHS and in coordination with other departments and agencies in the federal government.
3. Establishing criteria for and negotiation of assurances of compliance with institutions engaged in HHS-conducted or supported research involving human subjects.
4. Conducting programs of clarification and guidance for both the federal and nonfederal sectors with respect to the involvement of humans in research; and directing the development and implementation of educational and instructional programs and generating educational resource materials.
5. Evaluating the effectiveness of HHS policies and programs for the protection of human subjects.
6. Serving as liaison to presidential, departmental, congressional, interagency, and nongovernmental commissions and boards established to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues.
7. Promoting the development of approaches to avoid unwarranted risks to humans participating as subjects in research covered by applicable statutes and regulations.
Source: 65 Fed Reg 37,137 (June 13, 2000).