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DEPARTMENT OF DEFENSE RESEARCH Part One Developed by: U-MIC University of Michigan IRB Collaborative

Department of Defense research 3 Developed by: U-MIC

Department of Defense research 4 Developed by: U-MIC

Department of Defense research 5 Developed by: U-MIC COMPONENTS Air Force Air Force Academy Army Army Corps of Engineers Coast Guard Coast Guard Academy Defense Advanced Research Projects Agency (DARPA) Defense Intelligence Agency Marines Military Academy (West Point) Missile Defense Agency National Geospatial-Intelligence Agency National Guard National Security Agency National War College Naval Academy Navy Office of Naval Research Pentagon Force Protection Agency Tricare Health System U.S. Naval Observatory and others

Department of Defense research 6 Developed by: U-MIC 32 CFR 219

Department of Defense research 7 Developed by: U-MIC funding cooperation, collaboration, or other agreements property, facilities, or assets personnel 32 CFR 219

Department of Defense research 8 Developed by: U-MIC STUDY MONITOR more than minimal risk reports to IRB oversees research ensures subject safety may remove subjects may stop research

Department of Defense research 9 Developed by: U-MIC WAIVERS OF INFORMED CONSENT only during screening or retrospective analysis or granted by the appropriate Department of Defense component

Department of Defense research 10 Developed by: U-MIC EDUCATION AND TRAINING REQUIREMENTS DON-Supported Extramural Performers module (CITI) refresher courses

Department of Defense research 11 Developed by: U-MIC NAVY-SPONSORED INTERNATIONAL RESEARCH host country’s permission ethics review host country’s review board or Naval IRB with host country representation

Department of Defense research 12 Developed by: U-MIC SURVEYS AND INTERVIEWS check with appropriate component document component approval in IRB application

Department of Defense research 13 Developed by: U-MIC ENROLLING SOLDIERS command approval

Department of Defense research 14 Developed by: U-MIC PROHIBITED HUMAN SUBJECTS RESEARCH prisoners of war classified research chemical or biological agents

Department of Defense research 15 Developed by: U-MIC SCIENTIFIC REVIEW Army and Navy components funding agency academic unit chair or dean sound design likely to yield results significance of research scientific approach researchers’ qualifications facilities

Department of Defense research 16 Developed by: U-MIC COMPENSATION on-duty federal personnel off-duty federal personnel non-federal personnel no compensation for general study participation compensation for general study participation from a non-federal source compensation for general study participation from a federal or non- federal source blood draws: $50 maximum

THANK YOU. Brian Seabolt IRBMED 17 Developed by: U-MIC