The 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. Our mission is to lead or facilitate the prevention and resolution of concerns, disputes, and compliance issues related to laws, regulations, policies, accreditation and certification requirements, and other professionally accepted standards that impact the activities and reputation of the Medical School. Most regulations and standards are designed to protect people, animals, the environment, public dollars and trust, and/or our institutional integrity — shared goals that we can all work together to support and achieve.
In exercising its charge, the Office of Regulatory Affairs is involved in the following areas (including education, consultation, policy/procedure development, new initiative support, and problem-solving in all varieties):
- Animals used in research and education
- Authorship attribution; e.g., ghostwriting, plagiarism, authorship disputes
- Clinical Laboratory Improvement Act (CLIA)
- 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
- 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
- Inventorship and intellectual property (IP) issues
- Laboratory Safety
- Mentorship issues
- Occupational and environmental health and safety, particularly laboratory safety
- Outside Interest disclosures
- Public access (publication) policy
- Research or other scholarly misconduct: fabrication, falsification, plagiarism, and other egregious conduct
- Security of information: research data, including Protected Health Information (PHI)
- Sunshine Law (Open Payments Act)
- Whistleblower protection
The Office of Regulatory Affairs also is involved in the following matters:
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 will serve 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 University of Michigan Medical School and the University of Michigan Office of Research.
The Office of Regulatory Affairs offers expertise, support, and assistance to University of Michigan 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.
As part of the Laboratory Safety Initiative announced by University of Michigan President Schlissel in April 2015, the Medical School has established a Laboratory and Research Safety Oversight Program, which is led by the UMMS Laboratory Safety Executive Committee (LSEC). The purpose of this Program is to provide 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 U-M Office of Research (UMOR) 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.
The Office of Regulatory Affairs assists faculty with interactions with governmental oversight agencies, including preparation, hosting, and follow-up to inspections. The office also drafts comments to selected proposed federal regulations, policies, and guidance.
If you have a University of Michigan uniqname and level 1 password, visit our internal website: http://msa.med.umich.edu/regulatory-affairs. An internal list of contacts is available here.
If you are visiting this page from outside the University, but would like to know more about the Office of Regulatory Affairs, please call (734) 647-1576 or email our office.