COMDTINST M6500.1

Abstract

a. This Manual applies to: <br>(1) All biomedical and social-behavioral research involving human subjects conducted by CG activities or personnel, involving CG personnel and CG employees as research subjects or supported by CG activities through any agreement (e.g. contract, grant, cooperative agreement, or other arrangement) regardless of the source of funding, funding appropriation, nature of support, performance site, or security classification. It also applies to human subject research using CG property, facilities, or assets. <br>(2) Human subject research (as defined in paragraph 6.b) conducted in the development, testing or evaluation of any item, system, vehicle, aircraft, piece of equipment, or other materiel, even if a person is not the direct object of the research (e.g., training exercises associated with the testing of personal protective equipment when worn by a person). <br>(3) Human subject research that meets criteria for exemption as defined in reference (a) and as determined by the CG Institutional Review Board (IRB) Chair. Investigators shall not make this determination. <br>b. All CG research activities involving human subjects shall meet DHS requirements as set forth in references (b) and (c). <br>c. The CG will have two authorized IRBs, the COMDT (CG-11) IRB and the Research and Development Center (RDC) IRB. This instruction refers to both as the CG IRB. <br>d. The requirements in this Manual shall not be suspended or waived due to operational contingency or during times of national emergency, except by explicit action of the Commandant of the CG. <br>e. Nothing in this Manual is intended to supersede either the requirements for health or safety reviews required by other authority, or to limit the authority of health care practitioners to provide emergency medical care to the extent individuals are permitted to do so under applicable federal, state, or local law. <br><u>PURPOSE</u>. This Manual establishes policy, assigns responsibilities, and provides guidelines to ensure the protection of human subjects in research conducted by, within or for the Coast Guard (CG).