Some potential research participants may not fully comprehend written and/or verbal communication about a study because of, for instance, limited English proficiency (LEP): insufficient understanding of English; Illiteracy or low literacy: a reading...

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...

Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...

This page contains information regarding human subjects research that falls within the federal exemption categories or U-M exemption categories . Exempt human subjects research does require an application and determination in the eResearch system...

04/23/2021: This page has been archived, as it no longer fully reflects IRBMED practice. Expedited Category (8) pertains to the continuing review of research, regardless of its previously determined risk level. The IRB member performing expedited...

This template should be used when creating a One-Time Blood or Specimen Sample ( Minimal Risk ) informed consent document. You may not use this template if you plan to conduct genetic analysis on subjects’ samples you plan to submit subjects’...

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted a two-year approval may not be used to support proposals or future awards involving federal funding. Click here...

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Click here for PDF version.