Guidance
Jun 7, 2021

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
May 3, 2021

Single IRB (sIRB) and Cooperative Multi-Site Research

sIRB Timing, Fees and Budgeting When requesting IRBMED to be the reviewing sIRB, contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date. See section “IRBMED as the sIRB (accepting oversight)” of this guidance...
Tags: Regulatory Sponsor
Guidance
Dec 15, 2020

Reporting Time-Sensitive Modifications

PDF Version Revised 12/14/2020 NOTE: The following guidance does not apply to studies where IRBMED is relying on an external IRB for regulatory oversight ("ceding" IRB oversight). If your study is ceded, you must reach out to the IRB of Record for...
Guidance
Aug 31, 2020

Certification Preparatory to Research

Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (...
Guidance
Aug 10, 2020

Decedents

Research involving data and/or biospecimens from decedents (deceased i ndividuals) is not regulated under the Common Rule. However, if you or any member of the study team will be accessing Protected Health Information (PHI) of the decedent(s), the...
Guidance
Aug 10, 2020

Limited Data Sets

Research on coded private information , or on non-identifiable information, is not regulated under the Common Rule . However, HIPAA Privacy Rule protections apply if a coded or non-identifiable data set contains Protected Health Information (PHI) in...
Guidance
Jul 8, 2020

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 The federal...
Guidance
Jul 8, 2020

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
Jan 16, 2019

Transition to 2018 Regulations - ARCHIVED

04/23/2021: This page has been archived. This transition is largely complete. All new applications are evaluated according to 2018 Revised Common Rule. With questions, contact your IRB staff. On January 21, 2019 most provisions of the Revised Common...
Guidance
Jun 11, 2018

Adverse Event Reporting

Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. These guidelines apply only to IRBMED reporting. They do not apply to required...
Guidance
May 22, 2018

UMMS Biorepository Registration Decision Tree

This decision tree represents UMMS policy for registration of biorepositories funded by a UMMS Department , and/or operating in UMMS space, and/or directed by faculty with an appointment in the Medical School. For more information, see Medical...
Guidance
May 7, 2018

Expedited Review

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations for the protection of human subjects recognize that not all research warrants review by the full IRB at a convened meeting. Accordingly, DHHS...
Guidance
Feb 17, 2017

Tips on the REP Application and Supplement Form

An REP application must include an Application Supplement Form, uploaded in Section 08 . The Application Supplement Form, in combination with the eResearch Repository application (REP), to provides a comprehensive overview of the repository's...
Guidance
Feb 17, 2017

Responsibility for REP Oversight and Compliance

REP application and Application Supplement Form capture several different levels and types of information about a repository's processes and intents, including: information characterizing a repository to identify useful relationships for researchers...
Guidance
Aug 14, 2015

External Adverse Event (AE) Reporting

This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of non -UM investigators and non -UM IRBs , events about which the UM investigator receives a report, usually from the study sponsor...
Guidance
Jul 20, 2015

eResearch Regulatory Management (eRRM)

eResearch Regulatory Management (eRRM) is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.

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