DOE Human Subjects Protection Program
Established Policy
All research conducted at DOE institutions, supported with DOE funds, or performed by DOE employees, including research that is classified and proprietary, whether done domestically or in an international environment, must comply with all federal regulations and DOE requirements that address the protection of human subjects. These include:
- 10 CFR Part 745, DOE, Protection of Human Subjects (pdf)
- 45 CFR Part 46, Department of Health and Human Services (HHS), Protection of Human Subjects
- DOE P 443.1A, Policy on the Protection of Human Subjects
- DOE O 443.1A, Protection of Human Subjects
No research involving human subjects conducted with DOE funding, at DOE institutions, or by DOE personnel may be initiated without both a project assurance and approval by the cognizant Institutional Review Board (IRB) in accordance with 10 CFR 745.103.
The assurance must be an OHRP Federalwide Assurance (FWA). This requirement must be met before any research involving human subjects is initiated. Other responsibilities and requirements are found in:
- DOE P 443.1A, Policy on the Protection of Human Subjects, of 12/20/07, which establishes DOE-specific principles for the protection of human subjects in DOE research.
- DOE O 443.1A, Protection of Human Subjects, of 12/20/07, which establishes DOE procedures and responsibilities for implementing the policy and requirements set forth in 10 CFR Part 745, Protection of Human Subjects, and in DOE P 443.1A, Protection of Human Subjects.
Exceptions to DOE O 443.1A requirements are:
- Studies to improve environment, safety, and health programs.
- Occupational health surveillance.
- Tools for worker contractor performance.
Content reviewed: Jan. 16, 2008