Regulatory Knowledge and Support

The goal of the Regulatory Knowledge and Support Program is to be a centralized resource for assuring consistent standards in the protection of human subjects and compliance with University of Miami (UM) policies, and state and federal regulations. The program provides leadership, expertise, and guidance early in the planning of pre-clinical studies, clinical protocols, regulatory agency interface and filings, and clinical trials support throughout study implementation.

Services

The program can provide free consultations on how to improve the quality of regulatory adherence in clinical research protocols and assure participant safety through data and safety monitoring planning and implementation, particularly at the time of study development.

Resources

• Data and Safety Monitoring Board Training Manual for Investigator-Initiated Studies
• Primer for Investigational New Drug (IND) Holders
• VIDEO: Elements of a Successful Informed Consent

Tools & Templates

Human Subject Regulation Decision Charts
Adapted from the U.S. Department of Health & Human Services (HHS)

• Is It Research Involving Human Subjects? (PDF)
• Overall Decision Tree for Exemptions (PDF)
• Decision Tree for Education Settings Exemption (PDF)
• Decision Tree for Educational Tests Exemption (PDF)
• Decision Tree for Existing Data and Specimens Exemption (PDF)
• Decision Tree for Public Service Program Exemption (PDF)
• Decision Tree for Food Studies Exemption (PDF)
• Decision Tree for 45CFR46 Criteria for Consent Elements Waiver (PDF)
• Decision Tree for 45CFR46 Criteria for Consent Waiver (PDF)
• Decision Tree for 45CFR46 Criteria for Expedited IRB Review (PDF)

Contacts

Director of Research Support
Marisabel Davalos, MSEd., CIP
Phone: 305-243-6978
Email: mxd101@miami.edu