department of defense research

1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

2. department of defense research Part Two Developed by: U-MIC University of Michigan IRB Collaborative

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

4. research involving a human being as an experimental subject Department of Defense research 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 219.101(b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals. Developed by: U-MIC

5. research involving a human being as an experimental subject Department of Defense research An activity, for research purposes, where there is an interventionorinteraction 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 219.101(b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals. Developed by: U-MIC

6. research involving a human being as an experimental subject Department of Defense research An activity, for research purposes, where there is an interventionorinteraction 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 219.101(b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals. Developed by: U-MIC

7. research involving a human being as an experimental subject Department of Defense research An activity, for research purposes, where there is an interventionorinteraction 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 219.101(b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals. Developed by: U-MIC

8. research involving a human being as an experimental subject Department of Defense research 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 219.101(b) of 32 CFR, and research involving the collection or study of existing data, documents, records, or specimens from living individuals. Developed by: U-MIC

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

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

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

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

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

14. Brian Seabolt IRBMED thank you. Developed by: U-MIC