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Templates

Dec 16, 2020

Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources

The CBR plans to provide certain materials (biospecimens and/or data associated with or derived from them) (“CBR resources”) from individuals who have participated as research subjects in the CBR (“CBR participants”), for use in the research project...

Tags: Access

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

May 13, 2022

Quality Assurance and Quality Improvement (QA/QI) Projects

According to U-M Human Research Protection Program (HRPP) and federal (OHRP) guidance, IRB review and approval is not required for activities that are limited to Quality Assurance and Quality Improvement (QA/QI) activities. However, IRB approval is...

Tags: Regulatory Study Teams

Informational

Dec 17, 2020

Guidance for Writing HUM Applications for Creating a Biorepository at the CBR

This page provides guidance on policies and practices related to CBR activities. It is not an exhaustive set of instructions on how you should complete your HUM application for creating a biospecimen collection. IRBMED may require more information...

Guidance

Apr 16, 2015

Unanticipated Problems Involving Risks to Subjects or Others

For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page. Also see the University of Michigan Human Research Protection Program...

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

Guidance

Jul 23, 2021

Multi-Site and Performance Site applications: Reporting to IRBMED

This document provides the reporting requirements to IRBMED for both Multi-Site HUM application and Performance Site HUM application when U-M is a coordinating center is not the single IRB (sIRB)/IRB of record/reviewing IRB for sites other than U-M...

Tags: Study Coordinator CTSO Work Guide

Policies

Jun 18, 2020

Use and Distribution of Biospecimens and Data Policy

The University of Michigan Medical School (“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...

Tags: Data Use Biorepository Use

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