A Department of Defense Assurance for the Protection of Human Research Subjects is a commitment by an institution to comply with DoD, Federal, and other applicable regulatory requirements while engaging in non-exempt research with human subjects. The USAF Human Research Protection Official negotiates new DoD Assurances and renews existing DoD Assurances for:
DoD institutions / organizations / commands engaged in DoD or component-supported research with human subjects are guided by the ethical principles set forth in the 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" (The Belmont Report); DoD regulations for the Protection of Human Subjects (32 CFR 219); DoDI 3216.02_AFI 40-402; where applicable, Food and Drug Administration regulations; 45 CFR 46 (Subparts B, C, and D under the authority of the DoD); and any other applicable federal, state, and local laws.
The Assurance applies to research involving human subjects and activities that involve such research, even in part, regardless of whether the research is otherwise subject to federal regulation. The requirements of the Assurance apply to all programs within the institution and its DoD component and are not restricted by funding source (intramural or extramural), funding appropriation, nature of support, program budget activity (e.g., P6 versus other), program title, or security classification.
Institutional Review Boards within DoD organizations meet the requirements of the Common Rule, FDA regulations, and any DoD component-specific additional requirements.
The following institutions / organizations / commands have an approved DoD Assurance:
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