Oak Ridge Sitewide IRB and DOE Regulations, Policies and Guidance

The Oak Ridge Sitewide Institutional Review Board (ORSIRB) is committed to protecting the rights and welfare of subjects in human subjects research. The ORSIRB will review and oversee research conducted at participating sites to assure that it meets ethical principles and complies with federal regulations that pertain to human subjects protection.

Federal regulations, policies, and guidance the ORSIRB

U.S. Department of Energy Other Federal

DOE Protection of Human Subjects (10 CFR 745)

Protection of Human Subjects [45 CFR 46 (aka Common Rule)]

DOE Order Protection of Human Subjects Research (DOE Order 443.1C)

Part of U.S. Department of Health and Human Services (HHS) (45 CFR 46)

  • Centers for Disease Control and Prevention
  • National Institutes of Health

HPR-101-GENERAL-Human Subjects Protection Program Plan

U.S. Department of Defense (DOD) (32 CFR 219)

Health Insurance Portability and Accountability Act (HIPAA) (45 CFR 160 and 164)

To see the federal agencies that have signed on to follow the Common Rule, please visit the HHS-OHPR regulations and policy website.


There may be additional policies in place at your organization. Please check your local organization or contact your organization’s Human Subjects Protection Coordinator.

The researcher follows the ethical principles outlined in the April 18, 1979 report of The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, titled “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as “The Belmont Report.”

The Institution may, at its discretion, consider other ethical guidelines as well, including those set forth in the Nuremberg Code, the Declaration of Helsinki, the International Conference on Harmonization, professional society codes of ethics, and reports and recommendations from national advisory bodies, such as the National Bioethics Advisory Commission and the Secretary’s Advisory Committee on Human Research Protections.