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Policies

Apr 1, 2023

Establishment of Biospecimen Collections Within the Central Biorepository

The UMMS Central Biorepository (CBR) is a repository of human biospecimens that serves as central storage facility, point of research access, and administrative hub for research using these biospecimens and data associated with, or derived from them...

Tags: Data Use Biorepository Use

Policies

Nov 17, 2022

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

May 18, 2022

Statement of Practice: PEERRS Certification Requirements

This document replaces the March 11, 2019 "PEERRS Certification Requirements" document. Note: It is the responsibility of the PI to enforce appropriate human subjects protection education for study team roles where certification is not otherwise...

Policies

Mar 2, 2022

Statement of Practice: HIPAA and U-M study team members outside Michigan Medicine in eResearch applications

Consult guidance from Michigan Medicine Corporate Compliance Office (level-2 login or VPN required) and IRBMED for general definitions (PHI, HIPAA, Covered Entity, etc.) and concepts. The vast majority of studies subject to IRBMED oversight involve...

Tags: Study Coordinator Principal Investigator Study Teams IRBMED Statement of Practice

Policies

Jun 17, 2017

University of Michigan Medical School Central Biorepository Policy Acknowledgment and Authorship

It is important to recognize the University of Michigan Medical School (UMMS) Central Biorepository (CBR) and the Principal Investigators who collect research materials for the contributions they make to scientific advancement of projects utilizing...

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...