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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
Policies
Feb 23, 2023

Clinical Research Coordinator Certification Requirements

This Medical School Office of Research policy addresses the requirement for study team personnel in specific Clinical Research Coordinator (CRC) titles to hold a relevant certification.
Tags: Study Coordinator
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 19, 2022

Michigan Medicine Postdoctoral Research Fellows Policy

This policy sets forth the Michigan Medicine policy on Research Fellow appointments. Effective April 1, 2023.
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
Oct 15, 2021

Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control

To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices...
Tags: Study Coordinator Study Teams IRBMED Statement of Practice
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
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
Policies
Feb 27, 2020

Privacy and Confidentiality Protections for Individual-Level Data Policy

This policy operates subject to all applicable laws, regulations, and U-M policies regarding protection of clinical and research data. It sets standards specific to Central Biorepository (CBR) operations in accordance with sound ethical principles...
Tags: Data Use Biorepository Use
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
Nov 21, 2019

University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services

This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-...
Tags: MICHR
Policies
Aug 5, 2019

Statement of Practice: Ancillary Approval & Final IRBMED Approval

Click here for PDF version .
Policies
Jul 1, 2019

Grants Processing Deadline

The Medical School Grant Services & Analysis (GS&A) Office requests that all proposals be submitted to the office ten (10) business days prior to the sponsor's proposal deadline. This includes the cumulative time needed for both the Medical...
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
Mar 23, 2018

Indirect Cost Recovery

The Medical School's expectations regarding the recovery of indirect costs from Federal, Industry/For-Profit, and Non-Profit sponsor s.
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
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...

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

North Campus Research Complex (NCRC)
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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