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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...
Guidance
Mar 6, 2012

Accessing Medical Records

When requesting records the requestor must be listed on the approved IRB, provide the IRB# and approval letter. Medical record requests for research /review will be imaged and viewable in CareWeb . Health Information Management will generally image...
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When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications.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
Policies
Jun 18, 2020

Use and Distribution of Biospecimens and Data Policy

This policy operates subject to the Medical School Governing UMMS Research Biorepositories Policy ("Research Biorepositories Policy") and applies to all Central Biorepository (CBR) resources. This policy establishes a framework for appropriate...
Tags: Data Use Biorepository Use
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
Jun 11, 2018

Adverse Event Reporting

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...
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
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
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
Jun 5, 2017

Telephonic Consent - ARCHIVED

12/15/2021: This page has been archived. See Electronic Informed Consent and Waivers under OHRP, FDA and HIPAA pages for up-to-date information on similar topics. In most cases, a potential research subject (or subject's representative) must be...
Policies
May 19, 2022

Michigan Medicine Postdoctoral Research Fellows Policy

This policy sets forth the Michigan Medicine policy on Research Fellow appointments. Effective April 1, 2023.
Guidance
Feb 22, 2021

International Council for Harmonisation: Good Clinical Practice (ICH-GCP)

The following information applies to the conduct of clinical research at the University of Michigan under ICH-GCP E6(R2) Guidelines. International Council for Harmonisation (ICH) Good Clinical Practice ( GCP ) standards (ICH-GCP) standards are fully...
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
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...
Guidance
Nov 14, 2011

Complaints from Subject or Others about a Research Study

The table below presents instructions and guidance on reporting complaints from subjects or others.
Guidance
Oct 17, 2011

Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED

04/23/2021: This page has been archived. Please refer to the more comprehensive pages: Certification Preparatory to Research Decedents De-identified Limited Data Sets
Guidance
Feb 1, 2018

Exempt Under OHRP/FDA, but Regulated by HIPAA Applications - ARCHIVED

04/23/2021: This page has been archived. Please refer to the more comprehensive Exempt human subjects research and Federal Exemption Categories pages.
Policies
Dec 9, 2016

Recovering Full Indirect Costs: Industry Funded Research

This policy details the required process that should be used to negotiate the indirect cost rate with industry sponsors . The Medical School does not support indirect cost waivers on industry funded research. Please visit the Indirect Cost Waiver...
Policies
Mar 1, 2002

Establishing Subaccounts

This policy describes the threshold over which the establishment of subaccounts is expected for inter-unit research projects at the Medical School. This policy formalizes existing practice within the School and conforms to the usual expectations for...
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

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