Medical School Office of Research

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Federal Exemption Categories

Federal regulations governing human subjects protection specify categories of “human subjects research” that are “exempt from this policy.” [ 45 CFR 46.104 ]. See also OHRP's Human Subject Regulations Decision Charts: 2018 Requirements .

Guidance

Dec 4, 2024

Exempt Human Subjects Research

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...

Guidance

Apr 17, 2024

Payment to Research Participants

The IRBMED reviews the amount of payment, the proposed method, and timing of disbursement of payments investigators give to study participants to assure that they do not present undue influence [ 45 CFR 46 .116, 21 CFR 50 .20]. There is no set...

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Guidance

Mar 18, 2021

Assent of Children in Research

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. Links to additional information are...

Guidance

Oct 21, 2020

Prisoners in Research

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)...

Guidance

Oct 17, 2011

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED

04/23/2021: This page has been archived. Please refer to the more comprehensive pages: Certification Preparatory to Research Decedents De-identified Limited Data Sets

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Federal Exemption Categories

Exempt Human Subjects Research

Payment to Research Participants

Most Viewed

Assent of Children in Research

Prisoners in Research

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED

Medical School Office of Research