Regulatory Affairs and Assessment

Several offices under the Vice Provost for Research and Scholarship are dedicated to ensuring the integrity, safety and compliance of the sponsored programs we undertake. These professionals have a deep knowledge of regulatory requirements and know how to ensure that the end product of your work meets the utmost standards.

Regulatory Affairs and Assessment

Research Compliance and Quality Assurance

Professionals dedicated to supporting the research community through Quality Reviews for human subject research, Clinical Trial Disclosure support and oversight, Corrective and Preventive Action management and educational training sessions. These teams facilitate continuous quality improvement in the protection of our research participants and the integrity of data. 
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Human Subject Research Office and Institutional Review Boards

The University of Miami Institutional Review Boards (IRBs) review all human research conducted under the auspices of the University of Miami and serve as an IRB of record for Jackson Health Systems (JHS). They are composed of members from both scientific and non-scientific backgrounds. Membership includes faculty and staff from both UM and JHS, as well as representatives from the local community. 

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Conflict of Interest

The University of Miami values the relationships of our investigators with outside entities, and encourages appropriate collaborations that foster new scientific insights while assuring transparency and objectivity in research and the integrity of the scientific record. The University of Miami's conflict of interest (COI) and foreign influence (FI) policy is designed to promote objectivity in research, scholarly and educational activities funded under external grants, contracts or cooperative agreements. UDisclose is the University system that allows all individuals to disclose external financial interests, foreign engagements and other disclosures as required.

Find instructions for UDisclose here.

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Export Control Compliance

While the University applies the principles of freedom of inquiry and open exchange of knowledge, we must also be mindful of the federal laws and regulations governing the exchange of research materials and results that are subject to export controls.

Data Broker Services

The mission of Data Broker Services is to provide a centralized, standardized review of all requests for clinical data at UMSOM/UHealth. Data is increasingly the lifeblood of the organization and must flow to meet its needs. In an increasingly complex regulatory environment with concerns over information privacy and security, the flows of data, particularly identifiable and other sensitive data, must be balanced against compliance, security and regulatory risk.

Oversight Committees

Embryonic Stem Cell Research Oversight Committee (ESCRO)

Institutional Animal Care and Use Committee (IACUC)

Institutional Biosafety Committee (IBC)

More resources

Collaborative Institutional Training Initiative (CITI)

Complion

Disclosures & Relationship Management

Export Control Compliance

Foreign Engagement Guidelines

Foreign Influence on U.S. Research

Research Integrity

Research Misconduct