Compliance and Ethics: Approvals and Oversight

Effective research compliance relies on cooperative oversight and action from multiple University of Michigan units. Project teams are expected to uphold the core principles of U-M research compliance through ethical conduct, compliance with federal and state regulations, compliance with institutional guidelines, and a commitment to safeguarding U-M researchers and research. Learn more about the role of various U-M offices in upholding compliance standards.

U-M resources for compliance

Central offices within the Office for the Vice President for Research (OVPR), Michigan Medicine, and other units provide approvals for and oversight of the conduct of regulated research activity.  

The Research Ethics & Compliance website defines the OPVR research compliance programs and covers a broad range of activities from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research). In addition, the Office of Regulatory Affairs at the U-M Medical School leads or facilitates the prevention and resolution of compliance issues related to laws, regulations, policies, and accreditation and certification requirements.

Below summarizes the role of some of the OVPR central offices and other U-M units that facilitate research compliance and related business processes. Visit their websites to find more information.

Animal Care and Use

Animal Care and Use and the Institutional Animal Care and Use Committee provide oversight of vertebrate animal welfare in research and teaching.

Conflict of Interest (COI)

COI ensures compliance with sponsor requirements, including managing outside activity disclosure, review of potential individual and institutional conflicts of interest and the management of identified conflicts. Visit the COI page to learn more about the COI committees that review COI disclosures for OVPR faculty and staff and for the faculty and staff of the Medical School and Health System.

Controlled Substances in Research Monitoring

The Controlled Substances in Research Monitoring Program ensures compliance with federal and state regulations pertaining to controlled substances in the research setting.

Export Controls

Export Controls and the U-M Export Controls Review Committee ensure compliance with federal laws that govern how technology, technical data, technical assistance and items or materials (from software to satellites and more) are physically or electronically exported, shipped, transmitted, transferred or shared with foreign countries, persons or entities. 

Human Pluripotent Stem Cells

Human Pluripotent Stem Cells oversees the ethical issues related to the derivation and research use of human embryonic stem cells (hESC) and induced pluripotent stem cells (iPSC) 

Human Research Protection Program (HRPP)

HRPP protects the rights and welfare of participants in research conducted or reviewed by U-M.

• IRB-HSBS: The Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) is responsible for protecting the rights and welfare of human participants in research conducted by faculty, staff and students affiliated with the U-M campuses in Ann Arbor, Dearborn and Flint.
• IRBMED: The Institutional Review Board of the Medical School (IRBMED) oversees human subjects research conducted at the Medical School and Michigan Medicine, including research conducted off-site by University faculty and staff when acting as University employees or in connection with their University appointments.

Institutional Biosafety

The Institutional Biosafety Committee (IBC) assesses the biosafety containment level for research involving recombinant DNA and synthetic nucleic acid molecules, as well as overseeing research with other potentially hazardous biologics.

Office of Research and Sponsored Projects (ORSP)

ORSP officers are the authorized organizational representatives for U-M in all matters related to external sponsored projects. ORSP reviews and authorizes funding proposals, negotiates contracts and agreements, and provides nonfinancial post-award management. In addition ORSP identifies compliance requirement indicators and refers them to the appropriate specialized central offices for further review and oversight.

The Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS)

PEERRS provides online regulatory and responsible conduct of research training for faculty, staff and students.

Research Information Security

The Research Information Security Oversight Program (RISO) ensures compliance with federal information security requirements when controlled unclassified information or related security standards apply.

Research Security/International Engagements

Research Security/International Engagements cover engagements with foreign entities, including foreign talent requirement programs (FTRPs) and prohibitions on participation in malign foreign talent recruitment programs (MFTRP)

Regental Action Requests (RARs)

A RAR is the University form used to request the U-M Board of Regents’ approval for conflict of interest situations that meet the State of Michigan Contract Statute (also known as “statutory conflicts”) for contracts directly or indirectly between the university and one of the university’s employees.

University of Michigan Standard Practice Guides (SPGs)

Several SPGs at the University outline policies related to compliance and ethics in research. These policies, along with sponsor guidelines, help form the foundation for U-M’s excellence in research. Policies include:

• SPG 303.01: Openness in Research Grants, Contracts, and Agreements 
• SPG 303.03: Policy Statement on the Integrity of Scholarship
• SPG 303.05: Policy for Research with Human Participants 
• SPG 303.06: Research Data Stewardship Policy

Find a full list of University SPGs.

Mandatory disclosure policy for violations of federal criminal law

In addition to the compliance areas noted above, there is an important disclosure requirement as required by the Uniform Guidance (2 CFR Part 200.113): 

All employees and students of the University of Michigan must disclose, in a timely manner, all violations of federal criminal law involving fraud, bribery or gratuity violations potentially affecting a federal award or subaward.

All potential violations must be reported to the ORSP officer assigned to the award or subaward. All such disclosures will be reviewed by the appropriate University offices (e.g., the Office of Research, the Office of General Counsel) and, when warranted, reported to the relevant federal awarding agency or pass-through entity. Failure to make a required disclosure may result in any number of significant remedies, including suspension or debarment.