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Policies

Jul 10, 2020

Statement of Practice: eResearch Cross-Reference Table

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.

Tags: IRBMED Statement of Practice

Policies

Feb 12, 2020

Statement of Practice: IRBMED Finalization of Study Documents

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

Tags: IRBMED Statement of Practice

Policies

Feb 3, 2020

Statement of Practice: Flexibility Initiatives

The University of Michigan's federalwide assurance with the Department of Health and Human Services (HHS) allows the IRB flexibility in its application of federal regulations to studies not federally funded or FDA-regulated. Click here for PDF...

Policies

Aug 5, 2019

Statement of Practice: Ancillary Approval & Final IRBMED Approval

Click here for PDF version .

Policies

Mar 11, 2019

Statement of Practice: PEERRS Certification Requirements

This document replaces the August 22, 2018 "PEERRS Certification Requirements" document. Click here for PDF version. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where...

Policies

Aug 28, 2018

Statement of Practice: IRBMED Communication Methods for Study Teams

The IRBMED office prefers eResearch correspondence as a means of communication between IRBMED and study teams. Other communication options include phone, email, and in-person consultations. Click here for PDF version.

Policies

Aug 28, 2018

Statement of Practice: Interpretation of Expedited Category (8) - ARCHIVE

04/23/2021: This page has been archived, as it no longer fully reflects IRBMED practice. Expedited Category (8) pertains to the continuing review of research, regardless of its previously determined risk level. The IRB member performing expedited...

Policies

Aug 28, 2018

Statement of Practice: Interpretation of Expedited Category (5)

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...

Policies

Aug 28, 2018

Statement of Practice: Version Control of Informed Consent Document(s)

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.

Policies

May 26, 2017

Statement of Practice: Sections 15 and 16 of IRB Application

Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...

Policies

May 1, 2015

Statement of Practice: Flexibility Initiative: Two-Year Approvals - ARCHIVED

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...

Policies

May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 7 - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted Exemption 7 may not be used to support proposals or future awards involving federal funding. Note : Exemption 7...

Policies

May 1, 2015

Statement of Practice: Flexibility Initiative: Exemption 2A - ARCHIVED

This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Click here for PDF version.

Policies

Feb 18, 2015

Statement of Practice: External Adverse Event Reports & Unanticipated Problems

Click here for PDF version. UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events . Office of Human Research Protections (OHRP) guidance indicates that individual...

Policies

Feb 27, 2014

Statement of Practice: Approval Dates on Consent Documents & Recruitment Materials - ARCHIVED

This document is obsolete as of August 22, 2018. It has been replaced by Statement of Practice: IRBMED Finalization of Study Documents . Click here for PDF version of the current document . When watermarking consent documents and recruitment...

Guidance

Jul 10, 2020

eResearch Cross-Reference Table

These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...