The Office of Regulatory Affairs has primary responsibility for the following Medical School activities:

UMMS Conflict of Interest Board (MEDCOI)

The Medical School Conflict of Interest Board reviews disclosures by faculty members and/or professional staff and recommends appropriate conflict management for research and intellectual property activities. The board also develops policies in clinical and educational realms which govern the interactions of UMMS (faculty, staff, trainees, and students) with biomedical industries. The board serves as a resource in evaluating existent and potential relationships with biomedical industries and determining whether they are allowable within the provisions of established policies. This board is advisory to the dean of the Medical School and the University of Michigan vice president for research.

ClinicalTrials.gov

The Office of Regulatory Affairs offers expertise, support, and assistance to Medical School faculty and staff with registration and reporting of clinical research trials in ClinicalTrials.gov. The office also serves as the lead administrator of the ClinicalTrials.gov Protocol Registration System, which facilitates the provision of account administration, technical advice, consulting, problem solving, and compliance monitoring services.

Laboratory Safety

As part of the University’s Laboratory Safety Initiative, the Medical School has established a laboratory and research safety oversight program, which is led by the UMMS Laboratory Safety Executive Committee (LSEC). The program provides local oversight for issues related to academic and research laboratory safety in the Medical School. The UMMS program complements existing laboratory safety oversight at the University level, such as the Office of the Vice President for Research (OVPR) and Environment, Health & Safety (EH&S), by providing an additional level of oversight and facilitation as warranted by the size and complexity of the research program in the Medical School.

Governmental Interactions and Inspections

The Office of Regulatory Affairs assists faculty with interactions with governmental oversight agencies, including reports and inspection preparation, hosting, and follow-up. The office also drafts comments to selected proposed federal regulations, policies, and guidance.

In exercising its charge, the Office of Regulatory Affairs can be involved in the following areas (including education, consultation, policy/procedure development, new initiative support and problem-solving in all varieties):

• Accreditation
• Animals used in research and education
• Authorship attribution; e.g., ghostwriting, authorship disputes
• Biorepositories
• Clinical Laboratory Improvement Act (CLIA)
• ClinicalTrials.gov
• Comments on proposed governmental regulations, policies, and guidance
• Conflicts of interest: individual and institutional; in research, education, and clinical care
• Controlled substances
• Data and specimen security and sharing
• Data sharing and management plans
• Food and Drug Administration: clinical trials, IRB, GLP, GCP, GMP, GTP, etc.
• Freedom of Information Act (FOIA)
• Governmental interactions: inspections, interviews, correspondence, etc.
• Hazardous agents/materials: use, transport, shipping
• Human research protection program (HRPP)
• Interaction with industry, vendors, and tenants
• International engagement
• Inventorship and intellectual property (IP) issues
• Laboratory safety
• Mentorship issues
• Outside interest disclosures
• Public access (publication) policy
• Security of information: research data, including Protected Health Information (PHI)
• Sunshine law (Open Payments Act)
• Whistleblower protection