This is not an exhaustive set of instructions on how you should complete your HUM application. This information only provides guidance on citing policies and practices related to CBR activities. You may have more information within each section...

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 (...

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...

IRBMED has developed the eResearch Cross-Reference Table and Guide to guide study team members, IRB staff, and IRB board members in achieving complete and consistent resolution of all IRB review contingencies. Click here for PDF version.

This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version.

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...

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...

To ensure that study teams are utilizing the most recently IRB-approved consent document at the time of amendment, IRBMED has standardized version control practices. Click here for PDF version.

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...