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Policy Implementation

The Oak Ridge Institute for Science and Education (ORISE) assists the U.S. Department of Energy (DOE) Office of Science in the implementation of its program directed at ensuring compliance with federal and DOE regulations pertaining to the protection of human subjects participating in research. 

The Federal Policy for the Protection of Human Subjects was adopted by DOE on June 18, 1991, as Title 10 Code of Federal Regulations 745, Protection of Human Subjects, and expressed in DOE Policy 443.1A, Protection of Human Subjects.

Manuals, brochures and resource books are needed to facilitate understanding of the guidance identified in the DOE Orders. ORISE develops those materials and supports communication, education and knowledge-sharing in other ways, including:

  • Managing and facilitating workshops, workgroup conference calls and electronic discussion lists
  • Coordinating site reviews
  • Developing and maintaining websites
  • Administering databases

The protection of human subjects is a vast topic relative to ever-changing rules, regulations and guidance, as well as various issues specific to research type or population. A resource that combines that host of information in one publication was needed. Consequently, ORISE coordinated the development of the Human Subjects Protection Resource Book, a joint project of DOE, the U.S. Department of Defense and the U.S. Department of Veterans Affairs.

The Human Subjects Resource Book does not represent the office views or policies of any agency. Rather, it provides best practices for Institutional Review Boards (IRBs), investigators and research organizations. This resource also offers working members of 11 DOE facility IRBs a reference tool to respond to updated guidance and issues they might have in dealing with human subjects research.