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

Department of Defense research 3 Developed by: U-MIC research involving a human being as an experimental subject

Department of Defense research 4 Developed by: U-MIC research involving a human being as an experimental subject An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects.…This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section (b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals.

Department of Defense research 5 Developed by: U-MIC research involving a human being as an experimental subject An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects.…This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section (b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals.

Department of Defense research 6 Developed by: U-MIC research involving a human being as an experimental subject An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects.…This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section (b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals.

Department of Defense research 7 Developed by: U-MIC research involving a human being as an experimental subject An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects.…This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section (b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals.

Department of Defense research 8 Developed by: U-MIC research involving a human being as an experimental subject An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects.…This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section (b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals.

Department of Defense research 9 Developed by: U-MIC human subjects non-interventional not based directly on researcher-subject interactions example: tissue samples only experimental subjects data regarding effect of intervention or interaction not experimental subjects

Department of Defense research 10 Developed by: U-MIC LEGALLY AUTHORIZED REPRESENTATIVES may provide consent for experimental subjects only if research offers direct benefit

Department of Defense research 11 Developed by: U-MIC VULNERABLE SUBJECTS Subpart B Subpart C Subpart D pregnant women, fetuses, neonates prisoners children 45 CFR 46

Department of Defense research 12 Developed by: U-MIC UNDUE INFLUENCE service members recruitment informed consent no superior officers present

Department of Defense research 13 Developed by: U-MIC amendments convened IRB continuing review education and training requirements publications, presentations, reports

THANK YOU. Brian Seabolt IRBMED 14 Developed by: U-MIC