Medical School Office of Research

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Foreign Language Short Forms

Investigators are responsible for understanding and following the IRBMED Guidance for non-English speaking subjects before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a...

Guidance

Jul 9, 2018

Elements and Uses of a Repository

A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research , either by the investigator who collected them or by sharing the materials with...

Guidance

Jul 9, 2018

Federal Exemption Categories

Federal regulations governing human subjects protection specify 6 categories of “ human subjects research” as “exempt from this policy.” [ 45 CFR 46.101 (b)]. Refer also to OHRP Human Subjects Regulations Decision Charts 2 – 7. The federal exemption...

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Guidance

Jun 11, 2018

Other Reportable Information or Occurrence (ORIO)

Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED . Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in...

Guidance

Feb 7, 2013

Humanitarian Use Device Requirements for U-M Physicians & Investigators

The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in...

Guidance

May 8, 2015

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Foreign Language Short Forms

Elements and Uses of a Repository

Federal Exemption Categories

Most Viewed

Other Reportable Information or Occurrence (ORIO)

Humanitarian Use Device Requirements for U-M Physicians & Investigators

Decedents

Medical School Office of Research