DOE Human Subjects Resources

U.S. Department of Energy Human Subjects Protection
Resource Book

Cover of Human Subjects Protection Resource BookThe U.S. Department of Energy (DOE) is pleased to announce the revised 2012 Human Subjects Protection Resource Book. It was first produced in 2006 with updates in 2007 and 2012 to help the DOE address changes in science, regulations, and practices. The 2012 updated sections include:

  • Chapter 3 - The Regulatory Mandate to Protect Human Subjects
  • Chapter 9 - Administration of Institutional Review Boards
  • Chapter 14 - After Initial Review
  • Chapter 18 - Research on Specimens, Data, Documents, or Records
  • Chapter 23 - Accreditation of Human Research Protection Programs
  • Appendix E - DOE Order 443.1B

The Book is an attempt to synthesize the information currently available on the protection of human subjects in research. It has been prepared for the convenience and reference of investigators, IRBs, research organizations, research subjects, government agencies, and others. Regulations are cited when appropriate, as is federal guidance.

While the 2012 updates were done by DOE, the original resource book was a collaborative project of multiple federal agencies and universities. We thank all who participated in its development.

Elizabeth White
DOE Human Subjects Protection Program Manager
Office of Biological and Environmental Research
SC-23.2, Germantown Building
U.S. Department of Energy
1000 Independence Avenue, SW
Washington, DC 20585-1290
Phone: 301-903-7693
Fax: 301-903-0567

Content reviewed: March 17, 2015