In November 2006, the Secretary of the Navy delegated the sole authority and responsibility for execution and oversight of the Department of Navy (DoN) Human Research Protection Program (HRPP) to the Navy surgeon general. This authority applies to all human subject research conducted by naval activities or personnel, involving naval military personnel or DoN employees as research subjects, or supported by naval activities through any agreement, regardless of the source of funding, funding appropriation, the nature of support, performance site, or security classification.
- Support the Navy surgeon general in reviewing and approving Department of Defense (DoD)-DoN assurances for the protection of human research subjects submitted by performing institutions; accepting other federal assurances, if appropriate, or suspending or terminating DoN assurances, as required.
- Provide interpretation of statutes, federal regulations, DoD directives and instructions, and DoN instructions concerning human research protection.
- Develop and implement DoN policies and procedures for the protection of human research subjects.
- Provide subject matter expertise and guidance on human protections in DoN-supported research.
- Monitor the accountability of the DoN HRPP at performance sites.
- Monitor and oversee human research protocols through a headquarters-level administrative review process.
- Support the review and approval of research protocols when necessary.
- Review and address unanticipated problems involving risks to subjects or others, adverse events, and allegations of non-compliance and research misconduct.
- Review and approve agreements between performing institutions prior to assigning Institutional Review Board (IRB) review, approval, and/or oversight to other institutions.
- Develop and provide initial and continuing education and training programs in human research ethics to all levels of staff involved in the review, approval, conduct, management, or support of human research in the DoN.
- Maintain communication with the assistant secretary of defense for research and engineering ASD(R&E) and other DoD and federal agencies on significant issues concerning assurances and research protocols.
Includes all research for which the U.S. Navy or Marine Corps provides:
- Personnel(including researchers or subjects, or
- Materiel including nonpublic information used to identify or contact prospective subjects, or
- Property / facilities, or
- Intramural or extramural funding, regardless of source
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