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Guidance
Jul 29, 2020

Seeking Reconsent from Research Participants

Informed consent is an ongoing, interactive process throughout a participant’s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek...
Guidance
Jun 4, 2021

Information Blocking in a Blinded Study

Single Blind Studies : A research study done in such a way that the participants do not know (are blinded to) what treatment they are receiving to ensure the study results are not biased (the power of suggestion). Blinded studies are sometimes...
Tags: MiChart OnCore Support Participant Management
Guidance
Oct 21, 2020

Prisoners in Research

Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated , is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule)...
Policies
Mar 19, 2018

Consent and HIPAA Privacy Rule Authorization Policy

This policy aims to ensure that donor preferences are given due respect in the conduct of research projects that are facilitated by the Central Biorepository (CBR). It operates subject to the UMMS Policy Governing Tissue Sample Collection, Ownership...
Tags: Data Use Biorepository Use
Guidance
Feb 16, 2022

Research Involving Genetic, Genomic, and/or DNA Collection or Analysis

This guidance document outlines IRB expectations for research involving genetic analysis which generates or uses human genetic information through analysis of human biospecimens and/or data. For this guidance, the relevant human genetic information...
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
Nov 28, 2022

Updating IRB applications when Researcher(s) Leave U-M

When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in...
Tags: Regulatory Principal Investigator
Guidance
Sep 21, 2020

Waiver or Alteration of HIPAA Authorization

To use and/or disclose Protected Health Information (PHI) for research purposes , the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit...
Templates
Nov 25, 2021

Specialty Informed Consent Templates

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if...
Tags: Regulatory Study Coordinator Principal Investigator Participant Management Study Teams
Guidance
Jan 3, 2018

NIH Genomic Data Sharing Policy

All U-M IRBs ( IRBMED , IRB-HSBS , IRB-Dearborn, IRB-Flint) follow the same policy for genomic data sharing. Before submitting your application to conduct research involving genomic data sharing, please review U-M's policy page and the guidance...
Policies
Feb 23, 2023

Requirement to Use of the Clinical Research Coordinator Career Ladder

This policy outlines the required use of the Clinical Research Coordinator (CRC) career ladder.
Tags: Study Coordinator
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...
Informational
Dec 17, 2020

Guidance for Writing HUM Applications for Access to Biospecimens Stored 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 secondary use of biospecimens. IRBMED may require more information from...
Guidance
Apr 10, 2018

Clinical Research Billing Guidance (CRB)

The Clinical Research Billing (CRB) process insures that services provided as part of a clinical study are billed properly to the sponsor or third-party payor. Many organizations (on campus and off) are involved, and compliance is required at...
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...
SOPs
Jul 14, 2020

IRBMED Standard Operating Procedures

The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM) . The IRBMED Standard Operating Procedures serve as a reference for investigators , IRBs,...
Guidance
Feb 15, 2023

Non-Significant Risk (NSR) Medical Devices: Monitoring Requirements

This document provides guidance on the monitoring requirements for non-significant risk (NSR) device studies that are initiated by UM investigators and under IRBMED oversight . It also provides instructions on completing the IRB application for the...
Tags: Regulatory Study Coordinator Principal Investigator MICHR Study Teams Investigator Initiated
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
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...

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Office of Research
University of Michigan Medical School
1301 Catherine Street SPC 5624
Ann Arbor, MI 48109

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2800 Plymouth Road Building 520, 3rd Floor
Ann Arbor, MI 48109-2800

Phone: 734-615-1332
Fax: 734-615-9458
Email: ummsresearch@umich.edu

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