Update March 16, 2020: The process outlined below for urgent Amendments is being temporarily suspended until further notice. IRBMED has published new procedures and a workflow diagram for time-sensitive and urgent modifications to active research...

This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version.

This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-...

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Multi-site research (MSR) means that multiple participating sites are involved in supporting the conduct of the same research protocol. However, not all participating sites may perform the same functions to support the conduct of the research...

This document replaces the August 22, 2018 "PEERRS Certification Requirements" document. Click here for PDF version. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where...

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...

This illustrated biorepository informational sheet is designed to accompany the biorepository informed consent template . Click the button below to download the editable PDF document to your computer. Then edit and save the PDF to reflect the...

Expedited Category (8) pertains to the continuing review of research, regardless of its previously determined risk level. The IRB member performing expedited review under category 8 must determine that the ongoing and future research activity...