All research selected for funding involving human subjects, to include use of human biological specimens and human data, must comply with the federal regulations for human subjects protection. Further, research involving human subjects that is conducted or supported by the DoD must comply with 32 CFR 219, Protection of Human Subjects (and DoD Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research (http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf).
Institutions awarded funding for research involving human subjects must provide documentation of a current Assurance of Compliance with federal regulations for human subjects protection, such as a Department of Health and Human Services, Office of Human Research Protection Federal Wide Assurance (http://www.hhs.gov/ohrp). All institutions engaged in human subjects research, to include subcontractors, must also hold a valid assurance. In addition, all personnel involved in human subjects research must provide documentation of completion of human subjects research training.
For all proposed research that will involve human subjects in the first year or phase of the project, the institution must provide evidence of or a plan for review by an Institutional Review Board (IRB) upon final proposal submission to DARPA as part of their proposal, prior to being selected for funding. The IRB conducting the review must be the IRB identified on the institution’s Assurance of Compliance with human subjects protection regulations. The protocol, separate from the proposal, must include a detailed description of the research plan, study population, risks and benefits of study participation, recruitment and consent process, data collection, and data analysis. It is recommended that you consult the designated IRB for guidance on writing the protocol. The informed consent document must comply with federal regulations (32 CFR 219.116). A valid Assurance of Compliance with human subjects protection regulations along with evidence of completion of appropriate human subjects research training by all investigators and personnel involved with human subjects research should accompany the protocol for review by the IRB.
In addition to a local IRB approval, a headquarters-level human subjects administrative review and approval is required for all research conducted or supported by the DoD. The Army, Navy, or Air Force office responsible for managing the award can provide guidance and information about their component’s headquarters-level review process. Note that confirmation of a current Assurance of Compliance with human subjects protection regulations and appropriate human subjects research training is required before headquarters-level approval can be issued.
The time required to complete the IRB review/approval process varies depending on the complexity of the research and the level of risk involved with the study. The IRB approval process can last between one and three months, followed by a DoD review that could last between three and six months. Ample time should be allotted to complete the approval process. DoD/DARPA funding cannot be used toward human subjects research until ALL approvals are granted.
Award recipients performing research, experimentation, or testing involving the use of animals shall comply with the rules on animal acquisition, transport, care, handling, and use as outlined in: (i) 9 CFR parts 1-4, Department of Agriculture rules that implement the Animal Welfare Act of 1966, as amended, (7 U.S.C. § 2131-2159); (ii) National Institutes of Health Publication No. 86-23, "Guide for the Care and Use of Laboratory Animals" (8th Edition); and (iii) DoD Instruction 3216.01, “Use of Animals in DoD Programs.”
For projects anticipating animal use, proposals should briefly describe plans for Institutional Animal Care and Use Committee (IACUC) review and approval. Animal studies in the program will be expected to comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, available at http://grants.nih.gov/grants/olaw/olaw.htm.
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