Federal regulations governing human subjects protection specify categories of “human subjects research” that are “exempt from this policy.” [ 45 CFR 46.104 ]. The federal exemption categories are revised and expanded as part of Revised Common Rule (...

Expedited Category (5) pertains to research involving data/materials that have been collected previously for research or non-research purposes and/or will be collected solely for non-research purposes, provided that certain criteria are met. Click...

Many investigators have expressed uncertainty concerning when consent should be obtained from a subject who is being evaluated for possible eligibility to participate in one or more clinical trials. The following guidance has been developed to...

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 It is obsolete as of June 11, 2018.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 It is obsolete as of June 11, 2018.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.

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. More information is available here .

Advertisements for recruiting potential research subjects can take many shapes. Examples include: flyers in a hospital hallway or on a student union bulletin board; newspaper, radio or television ads; direct mailings; electronic mail announcements;...

Federal Guidance [Office of Human Research Protections ( OHRP )] OHRP FAQs University of Michigan Subject becomes a prisoner / Study not previously approved to recruit prisoners seeks to enroll new subject who is a prisoner Created 4/17/2012

Many patients at the University of Michigan Health System do not speak English or lack the fluency to understand medical and scientific information presented in English. In order for such a patient to participate in a research study, steps must be...