Human Subjects Regulations, Orders, and Policies

DOE Directives and Documentation

April 2013 Clarification Memo from DOE IO Regarding Research Involving Intentional Modification of an Individualís Environment
Clarification Memo for DOE-funded or DOE laboratory-managed or conducted projects. Clarify the DOE requirements for research involving intentional modification of an individual’s or a group of individuals’ environment, for example through installation of devices in homes and/or through introduction of gases/chemicals to trace airflow in occupied residential, commercial, or public settings.

DOE O 443.1B, Protection of Human Research Subjects, dated 3-17-11
Establishes DOE procedures and responsibilities for implementing the policy and requirements set forth in Title 10 Code of Federal Regulations (CFR) Part 745, Protection of Human Subjects, and the Secretarial Policy Memorandum on Military or Intelligence-Related Human Subject Research, December 9, 2009.

DOE Human Subjects Protection Resource Book
Office of Biological and Environmental Research, 2007. Synthesizes the information currently available on the protection of human subjects in research, the continuing application of such information to new areas of endeavor, and the ever-changing rules, regulations, and guidance involved.

DOE O 484.1, Reimbursable Work for the Department of Homeland Security, dated 8-17-06.
Establishes DOE policies and procedures for the acceptance, performance, and administration of reimbursable work directly funded by the Department of Homeland Security. Cancels: DOE N 481.1 and DOE N 251.62.

DOE O 481.1C, Work For Others (Non-Department of Energy Funded Work), dated 1-24-05
Establishes the policy, responsibilities, and procedures for authorizing and administering work for non- DOE entities by DOE/National Nuclear Security Administration (NNSA) and/or their respective contractor personnel or the use of DOE/NNSA facilities that is not directly funded by DOE appropriations.

DOE O 412.1A, Work Authorization System, dated 4-21-05
Provides the policy, responsibilities, and procedures for authorizing and administering DOE-funded work performed under DOE contracts.

DOE M 481.1-1A Chg 1, Reimbursable Work for Non-Federal Sponsors Process Manual, dated 9-28-01
Provides detailed requirements to supplement DOE O 481.1C, Work For Others (Non-Department of Energy Funded Work), dated 1-24-05, which establishes requirements for the performance of work for non-DOE/non-NNSA entities by DOE/NNSA/contractor personnel and/or the use of DOE/NNSA facilities that is not directly funded by DOE/NNSA appropriations.

DOE M 483.1-1, DOE Cooperative Research and Development Agreements Manual, dated 1-12-01
Provides detailed requirements to supplement DOE O 483.1, DOE Cooperative Research and Development Agreements, dated 1-12-01, which establishes requirements for the performance of technology transfer through the use of Cooperative Research and Development Agreements (CRADAs).

DOE O 241.1A Chg 1, Scientific and Technical Information Management, dated 10-14-2003
Establishes Department of Energy (DOE) requirements and responsibilities to ensure that scientific and technical information (STI) is identified, processed, disseminated, and preserved in a manner that (a) enables the scientific community and the public to locate and use the unclassified and unlimited STI resulting from DOE’s research and related endeavors and (b) ensures access to classified and unclassified sensitive STI is protected according to legal or Departmental requirements.

National Nuclear Security Administration Act, Title 32, Pub. L No. 106-65, as amended (pdf)
Establishes the formation of NNSA within DOE.

Code of Federal Regulation Documents

Note: Code of Federal Regulation documents may be searched for and accessed on the gpoaccess.gov site.

10 CFR 1008, Records Maintained On Individuals (Privacy Act)
Establishes the procedures to implement the Privacy Act of 1974 (PL. 93–579, 5 U.S.C. 552a) within the Department of Energy.

10 CFR 600, DOE Financial Assistance Rules
Provides the policies and procedures for administration and management of all DOE financial assistance activities.

10 CFR 602, Epidemiology and Other Health Studies Financial Assistance
Sets forth the policies and procedures applicable to the award and administration of financial assistance agreements and cooperative agreements for health-related research, education/training, conferences, communication, and related activities.

10 CFR 605, Office of Science Financial Assistance Program
Provides policies and procedures for the administration and management of basic and applied research financial award agreements awarded by the Office of Science.

10 CFR 745, Protection of Human Subjects
Sets out Federal requirements for DOE for the protection of human subjects involved in research activities.

45 CFR 46, Protection of Human Subjects
Sets out DOE-prescribed HHS requirements for protected classes of human research subjects.

U.S. Code

5 United States Code 552, The Freedom of Information Act (Public Law 89-487 as amended)
Establishes the right of citizens to request information from Federal agencies and establishes a framework of procedures to implement this right. Search for this document on gpoaccess.gov.

Content reviewed: September 29, 2014