Regulatory Review & Compliance
Medical School Office of Research

While moving discoveries from bench to bedside as quickly as possible is a top priority, we are dedicated to doing so with integrity and in a safe, compliant, and ethical manner.

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IRBMED Guidance
Animal Care & Use Policies
Research Project Route Map
Pre-Award Compliance

Grant Services & Analysis provides an up-to-date list of Authorized Signers to contact for unit and school review/commitments. This list contains all department authorized signers for Medical School effort and space, as well as authorized signers for Hospital and Health Center space.

To facilitate the effective review of proposals, Grant Services & Analysis requires certain proposal components be complete at the time the proposal is routed. Those required components are outlined by sponsor/proposal type on the Required Proposal Components page.

Grant Services & Analysis also provides the following resources:

Before being sent to the proposed sponsor, every grant or contract application must be submitted for prior approval through the appropriate University channels. The Proposal Approval Form (PAF), which is part of the eResearch Proposal Management system, accompanies the proposal to record the appropriate signatures to indicate approval of the proposed project.

Clinical Research

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Correctly identifying whether your study is a clinical trial is crucial in complying with NIH policies and Michigan Medicine.

Submitting an intake form allows the appropriate Clinical Trial Support Unit to determine what services a study team may need and initiate pre-award support. When filling out the Intake Form, you will need to know principal investigator information, study team contact information, department pre-award research administrator information, and study information, including project title, funding, type of trial, and trial phase.

Clinical Trials Support Units (CTSUs) are business units that partner with investigators and their teams to ensure the timely and efficient activation and execution of clinical trials at Michigan Medicine.

The CTSUs allow investigators to focus on their research and patients, instead of administrative tasks. CTSUs use a standard set of work guides to harmonize elements across the clinical research enterprise while allowing for local flexibility to reflect the uniqueness of various types of research. CTSUs provide mandatory pre-/post-award support and optional study coordinator support. When working with the Support Units, the six non-oncology units may be referred to as M-CTSU and Oncology as O-CTSU.

All clinical research being serviced by a CTSU is managed in OnCore, an enterprise Clinical Trials Management System. OnCore allows for automated standard interfaces with MiChart, which helps reduce duplicate data entry and integrates clinical research billing for increased efficiency and accuracy. OnCore provides subject and financial management for all clinical research at Michigan Medicine.

For more information, visit the Clinical Trials Support Units page.

Regulatory Review

The Human Research Protection Program (HRPP) is an institutional-wide program coordinated by the University of Michigan Office of Research (UMOR) and composed of the executive officers, research review committees, and other entities that are responsible for protecting the rights and welfare of participants in research conducted or reviewed by the U-M.

As part of the HRPP, the primary goal of the Institutional Review Board of the Medical School (IRBMED) is to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Michigan.

For your convenience, the Medical School Office of Research has curated all policies and guidance documents into Research A-Z, a one-stop-shop for research guidance, templates, policies, and standard operating procedures (SOPs). Research A-Z is managed and regularly updated by the staff of the Medical School Office of Research as a tool for the entire biomedical research community at the University of Michigan.

Conducting animal research? Those polices and guidelines are also available in Research A-Z.

In order to ensure that the highest animal welfare standards are maintained along with the conduct of accurate, valid scientific research at the University of Michigan, Principal Investigators must obtain approval from the Institutional Animal Care & Use Committee (IACUC) before initiating any research, testing, or instructional project(s) that involve the use of vertebrate animals.

The IACUC, along with veterinary staff specializing in laboratory animal medicine, carefully review the goals, objectives, and scientific benefits of all proposed projects to verify that:

  • The project has appropriate merit;
  • The proposed research complies with all federal, state, and University laws, regulations, and guidelines;
  • Humane use guidelines are followed and all animals involved are provided with the best possible treatment and professional veterinary care;
  • Those who will be working with the animals have received proper training; and
  • Proper practices and procedures are in place to reduce as much pain and/or distress to the animals as possible.

Just getting started? The Animal Care & Use (ACU) Program’s Quick Reference Guide includes all of the information you’ll need to get started with animal care and use at the University of Michigan. At a glance, you'll find:

  • The most important animal care and use links to bookmark,
  • Featured resources, insider tips, and contact information for six key programmatic areas,
  • Contact information for your animal care and use team,
  • Frequently required grant data, and
  • Ways to keep track of important lab information such as emergency contacts, location of lab records, and a checklist for general lab maintenance.

To learn more about the processes used to review animal use protocols, visit the Animal Care & Use Program website. A complete listing of animal care and use policies, guidelines, and standard operating procedures (SOPs) is available on the Animal Care & Use Program Research A-Z website.

The University of Michigan defines a conflict of interest (COI) as: "A situation where a faculty or staff member is in a position to influence the business, research, or other decisions of the University in relationship to an outside organization that could lead directly or indirectly to financial gain for that individual or the family of that individual, or give improper advantage to others to the detriment of the University." For more information, visit Research Ethics & Compliance.

Within the Medical School, the UMMS Office of Regulatory Affairs works to build and maintain a strong foundation of regulatory good-standing upon which the Medical School’s missions can flourish. They provide resources regarding Conflict of Interest and ClinicalTrials.gov Requirements.

Privacy and security must be a top priority for all to safeguard against the unauthorized disclosure of patient data and other sensitive information. You can receive guidance on privacy and security safeguards when sharing patient health data with collaborators through the Data Office. Ensure that your data is being stored and handled properly by reading Handling Patient Data General Security Guidelines.

In addition, it is your responsibility to ensure all of your devices that store sensitive patient information are encrypted. This includes all removable media or portable electronic devices used to store, transfer, or access sensitive information (refer to Michigan Medicine Policy 01-04-502). For information on how to ensure your device is secured to meet this policy visit the Sensitive Data Guide to IT Services.

Questions?
Contact Us
Office of Research
University of Michigan Medical School
Phone: 734-763-4272
7313 Medical Science I Building
1301 Catherine Street
Ann Arbor, MI 48109-5624

North Campus Research Complex (NCRC)
Building 520, 3rd Floor
2800 Plymouth Road
Ann Arbor, MI 48109-2800
Upcoming Office of Research Events All Office of Research Events
Amendments and Continuing Reviews
This course is a follow-up to Initial Project Applications and will examine the process for submitting amendments and scheduled continuing reviews to IRBMED using eResearch once a project’s initial application has been approved.
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Data and Safety Monitoring Boards and Data Safety Monitoring Plans
This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP. A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data.
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Microscopy Core: Advanced Biological EM Methods Interest Group
Learn About Advanced Electron Microscopy (EM) Methods.
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Storage and Retention of Data
This course will review the fundamentals of maintaining confidentiality of subject data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and de- identified datasets.
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Bioinformatics Core Summer Workshop Series
Composed of the two companion workshops (Computational Foundations and RNA-Seq Demystified), this virtual workshop series is for researchers who would like to better understand the analysis of differential gene expression in bulk RNA-Seq data.
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Introduction to sIRBs
This course will identify the Single IRB model for Multi-Site research, show the regulatory requirements of sIRB review and the exceptions to sIRB requirements, and explain sIRB requests of IRBMED as sIRB (accepting oversight), External IRB as sIRB (ceding oversight), and UofM as the Coordinating Center.
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Flow Cytometry Core FlowJo™ Software Training
Learn how to use the FlowJo™ workspace, including how to load files, evaluate sample quality, draw gates, generate tabular and graphical layouts, and perform compensation. Designed for those new to the software or need a refresher.
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Microscopy Core: Advanced Biological EM Methods Interest Group
Learn About Advanced Electron Microscopy (EM) Methods.
A close up of a microscope's eye pieces.
FDA Research Involving Drugs and Devices
This course will review what research is subject to FDA oversight, highlight the differences between OHRP and FDA regulations, learn the responsibilities of sponsors, investigators, and the IRB when conducting and reviewing research involving drugs and devices, and examine the requirements for conducting research with a drug or biologic/medical device.
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Featured Office of Research News All Research News Fun illustration in red, white, and blue, with the words "fourth of July"
Office of Research
Several Cores Closed for the Holiday
In observance of the Independence Day, several cores will have a change in operations.
Photo of an RN sitting with a patient in the MCRU space
Office of Research
New RN Pool Available to Support MCRU Overnight & Extended Hours
The Michigan Clinical Research Unit (MCRU) is excited to announce the development of an overnight RN pool to support overnight/extended hours. If you have current or upcoming studies that require overnight RN services in MCRU, contact [email protected] for more information.
FFMI fastPACE spring 2024
Office of Research
Register Today! FFMI fastPACE Spring Cohort Begins Friday, May 10
Don't miss your chance to participate in this project-based, experiential course designed to help academics launch new innovations, including medical devices/diagnostics, digital solutions, drugs, educational/training interventions, research tools, and many others.