Human Subjects Research Resources
This page contains quick links to U-M IRBs, U-M policies, and external websites related to human subjects research that ORCR frequently references when working with investigators and U-M units.
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(PDF) Screenshot with annotated guidelines for amending the Project Summary and Supporting Documentation sections of an IRB application. Provided by IRB-HSBS. Last Updated: 2024
Research involving children requires that adequate provisions are made for soliciting the assent of the child and the permission of their parents or guardians consistent with the standards described in 45 CFR 46.408.
Children who reach the age of majority while participating in a study must be consented if continuing interventions or interactions are planned (including collection or analysis of identifiable private information), as described in 45 CFR 46.116. The IRB may grant a waiver of consent under 45 CFR 46.116 (e), if it finds that required conditions are met, but must document its decision and rationale for doing so. For considerations of age for obtaining and documenting assent, please refer to Assent Age Ranges Guidance.
Authorization agreement guidance
See also: Collaborative research, single IRB review
Questions?
If you should have any questions regarding the tools listed on this page, contact the Office of Research Compliance Review at [email protected].