Department of the Navy
Human Research Protection Program
In SECNAVINST 3900.39D, dated 6 November 2006, the Secretary of the Navy delegated the sole authority and responsibility for execution and oversight of the DON Human Research Protection Program (HRPP) to the Surgeon General of the Navy (SG). The SG's 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.
The mission of DON HRPP is to ensure the provision of ethical treatment of human subjects in DON research by promoting adherence to ethical principles, laws, regulations and policies for the protection of human subjects.
DON HRPP is a world-class research protection program, dedicated to preserving the rights and protecting the welfare of human subjects in the Navy and Marine Corps supported research.
The functions of the DON HRPP include:
- Supporting the Surgeon General in reviewing and approving 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,
- Providing interpretation of statutes, federal regulations, DOD directives, and DON instructions concerning human research protection,
- Developing and implementing DON policies and procedures for the protection of human research subjects,
- Providing subject matter expertise and guidance on human protections in DON-supported research,
- Monitoring the accountability of the DON HRPP at performance sites,
- Monitoring and overseeing human research protocols through a headquarters-level administrative review process,
- Supporting the review and approval of research protocols when necessary,
- Reviewing and addressing unanticipated problems involving risks to subjects or others, adverse events, and allegations of non-compliance and research misconduct,
- Reviewing and approving agreements between performing institutions prior to assigning Institutional Review Board (IRB) review, approval, and/or oversight to other institutions,
- Developing and providing 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, and
- Maintaining 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.