To use and/or disclose Protected Health Information (PHI) for research purposes , the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit...

When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in...

This document is obsolete as of August 22, 2018. It has been replaced by Statement of Practice: IRBMED Finalization of Study Documents . Click here for PDF version of the current document . When watermarking consent documents and recruitment...

This document replaces the March 11, 2019 "PEERRS Certification Requirements" document. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where certification is not otherwise...

All U-M IRBs ( IRBMED , IRB-HSBS , IRB-Dearborn, IRB-Flint) follow the same policy for genomic data sharing. Before submitting your application to conduct research involving genomic data sharing, please review U-M's policy page and the guidance...

The table below presents instructions and guidance on reporting complaints from subjects or others.

Blood draws for research purposes should be limited to the smallest necessary volume. Maximum blood draw volumes for research should also take into account blood drawn for clinical care. Investigators should coordinate with clinical teams regarding...

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if...