REGULATORY REVIEW & COMPLIANCE

While moving discoveries from bench to bedside timely and efficiently is a top priority, we are dedicated to doing so with integrity and in a safe, compliant, and ethical manner. Several Medical School Office of Research units support the responsible conduct of research. Research preformed at the University of Michigan is governed by institutional policies.

The Clinical Trials Support Office (CTSO) provides central infrastructure and strategic oversight in the administration of the seven trans-departmental Clinical Trial Support Units (CTSUs) that are aligned around common areas of research. The CTSO has established partnerships with the Michigan Institute of Clinical & Health Research (MICHR), Calendar Review & Analysis Office (CRAO), Office of Research & Sponsored Projects (ORSP), Research Pharmacy, Insititutional Review Boards (IRB), and many others to focus on the efficient and timely activation and conduct of Medical School clinical trials.

The five Institutional Review Boards of the University of Michigan Medical School (IRBMED) are responsible for monitoring compliance with federal and state laws, university policies, and ethical principles governing human subjects research in order to protect the rights and welfare of all participants in research studies conducted throughout Michigan Medicine.

The Calendar Review and Analysis Office maintains quality assurance processes in clinical research billing by confirming that the items and services study teams intend to bill to Medicare and other third-party payers are consistent with federal regulations and institutional policies.

The Animal Care & Use Program supports the University of Michigan community in its pursuit of impactful science to benefit both human and animal health by fostering a culture of excellence and compassion, responsible research conduct, and a shared commitment to upholding the highest animal welfare standards in all aspects of research, testing, and teaching. The Program operates according to the policies, standards, and guidelines set by the University, the State of Michigan, and the United States Government, which require a review of animal activities to ensure the humane treatment and judicious use of vertebrate animals. In addition to adhering to the standards governing laboratory animal care and use, our Animal Care & Use Program is also accredited by AAALAC International, a private non-profit organization that promotes the humane treatment of animals in science through voluntary program assessments and subsequent accreditation.

Grant Review & Analysis Office reviews over 3,000 proposals each year to ensure that the Medical School adheres to federal guidelines and best practices in sponsored research.

PRE-AWARD COMPLIANCE

Unit & School Review/Commitments

The Grant Review & Analysis Office 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. 

Proposal Routing

To facilitate the effective review of proposals, the Medical School Grant Review & Analysis Office 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.

The Grant Review & Analysis Office also provides the following resources:

Proposal Submission: Proposal Approval Form (PAF)

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.

The PAF is a summary of information about the project that is used for internal review and approval and data management. The PAF is not submitted to the proposed sponsor.

For more information, view ORSP's PAF Instructions.

CLINICAL RESEARCH

Defining a Clinical Trial

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.

If you answer yes to the following questions, then your study qualifies as a clinical trial:

  • Does the study involve one or more human subjects?
  • Does the study involve the use of one or more interventions?
  • Does the study prospectively assign human subject(s) to an intervention(s)?
  • Does the study have a health-related biomedical or behavioral outcome(s)?

Learn more about the NIH Clinical Trial Definition at nih.gov, or contact the Clinical Trials Support Office with questions.

Submit Intake Form

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

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. A faculty Medical Director(s) experienced in conducting clinical trials leads each unit with support from a senior administrator.

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 trial enterprise while allowing for local flexibility to reflect the uniqueness of various types of trials. CTSUs provide mandatory pre-/post- award support and optional study coordinator support. All of the CTSUs offer a Finance Lead, Contract & Grants Specialist, Project Coordinator, and Study Coordinator Support. The seven CTSUs are:

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

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

REGULATORY REVIEWS

IRBMED Policies & Guidance

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 University of Michigan 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.

Animal Research

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.

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 A-Z website.

Finalize Regulatory Approvals: Conflict of Interest

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 key icon 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, Compliance & Integrity, and ClinicalTrials.gov Requirements.

Guidance on Data Security

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 for Clinical & Translational Research (DOCTR). 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 Health Information Technology & Services (HITS) Knowledgebase.

Questions?

Contact Grant Review & Analysis at msgrants@umich.edu or 734-763-4272 / (Fax 734-615-9458)

Contact the Clinical Trials Support Office at CTSOgroup@umich.edu

Contact IRBMED at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

Contact the Animal Care & Use Office at acuoffice@umich.edu or 734-763-8028

A full list of staff is available in the Personnel Directory.