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
Program Director
Jonelle Wright, Ph.D.
Associate Director, Miami Clinical & Translational Science Institute (CTSI)
Associate Dean, Research & Regulatory Quality Improvement
Research Associate Professor, Department of Surgery
Email: jwright2@med.miami.edu
Director of Research Support
Marisabel Davalos, MSEd., CIP
Phone: 305-243-6978
Email: mxd101@miami.edu
Director, Regulatory Support
Sorelly Gil, MD, MBA