Ancillary Committees

Cancer - Protocol Review Committee (PRC)

http://sylvester.org/shared-resources/clinical-research

An approval letter from the PRC must be obtained for studies involving interventions with participants who have cancer. Interventions include the use of investigational therapies, surgery, drugs, etc. The IRB requires a copy of the initial approval letter from the PRC.

Contact:
Laura Varela
Manager, Research Support
Sylvester Comprehensive Cancer Center
Phone 305-243-7185
lvv1@med.miami.edu

Pathology – Pathology Protocol Review Committee (PPRC)

http://pathology.med.miami.edu/

Research involving the use of any patient specimens collected at any UM/JHS patient care facility; or use of Department of Pathology expertise and/or facilities may be subject to review by the UM Pathology Protocol Review Committee (PPRC). If the research consists of using, collecting or storing human biological samples including urine and blood samples, PPRC approval is required.

The IRB requires a copy of the PPRC approval letter at the time of initial and continuing review. Please refer to Pathology Committee Requirements and fill out the Pathology Protocol Questionnaire and submit it to Pathology along with a copy of the protocol. Please visit the Department of Pathology’s website at http://pathology.med.miami.edu for further information.

Contact:
Maritza Polania
Manager, Research Laboratory
Department of Medicine
305-243-6011
mpolania@med.miami.edu

Radiation Materials – Radiation Safety (HRSC)

http://facilities.med.miami.edu/divisions/radiation-cont

Approval from HRSC must be obtained for protocols where radiation/radio active materials (not MRI, Ultrasound or Laser Treatment) or radiation producing devices are being used for research purposes and not simply as the standard of care. Such submissions will be routed to HSRC by eProst upon receiving departmental approval. The IRB requires initial approval from the HRSC prior to initiating its review of a study.

Contact:
Edward Pombier
Director
Radiation Control Center
305-243-6369
epombier@med.miami.edu

Recombinant DNA Materials – Institutional BioSafety Committee (IBC)

http://uresearch.miami.edu/regulatory-compliance-services/ibc

Research involving any work with studies involving recombinant DNA (rDNA) must be approved by the UM Institutional BioSafety Committee (IBC) prior to receipt of IRB approval. Such studies include gene transfer trials or the collection of specimens that will be used in rDNA lab studies. Such submissions will be routed to IBC by eProst upon receiving departmental approval. The IRB requires initial approval from the IBC prior to initiating its review of a study.

Contact:
Dr. Ellen Kapsalis
Director of Compliance
IACUC / IBC / ESCRO
305-243-2311
ekapsalis@miami.edu

Stem Cell Research – Embryonic Stem Cell Oversight Committee (ESCRO)

http://uresearch.miami.edu/regulatory-compliance-services/escro

Research involving any work with the use of human embryonic stem cells and/or their derivatives must be approved by the UM Embryonic Stem Cell Research Oversight Committee (ESCRO) prior to receipt of IRB approval. Such submissions must be submitted to the ESCRO committee outside of the eProst system upon receiving departmental approval. The IRB requires initial approval from the ESCRO committee prior to initiating its review of a study. Please visit the ESCRO committee website at http://uresearch.miami.edu/default.asp?p=178 for further information.

Contact:
Dr. Ellen Kapsalis
Director of Compliance
IACUC / IBC / ESCRO
305-243-2311
ekapsalis@miami.edu

Biological Agents – Office of Environmental Health and Safety (Biosafety Officer)

http://www.miami.edu/finance/index.php/environmental_health_safety/

Research involving any work with infectious or potentially infectious biological agents may be subject to review by the UM Office of Environmental Health and Safety (EHS) through the UM Biosafety Officer prior to receipt of IRB approval. Approval from EHS must be obtained for studies involving Biosafety Level 2 (BSL2) and higher agents. The IRB requires initial approval from the EHS – Biosafety Officer prior to initiating its review of a study. Please complete and upload the Biological Agents Registration Form into eProst as required.

Contact:
Jairo Betancourt, RBP
Biosafety Officer
Office of Environmental Health and Safety
305-243-3269
jbetancourt@med.miami.edu

Clinical Research Operations and Regulatory Support (CRORS)

http://uresearch.miami.edu/regulatory-compliance-services/clinical-research-operations-regulatory-support-crors

Review and approval from the CRORS ancillary committee will be required for new studies if the study involves an investigator-held IND or IDE and for amendments to studies involving an investigator-held IND or IDE. The CRORS ancillary committee will not review continuing/final reports.

Contact:
Sorelly Gil, MBA, CCRC
Manager, Regulatory Support
_Clinical Research Operations and Regulatory Support _
305-243-0493
sgil@med.miami.edu

Clinical Translational Research Site (formerly Clinical Research Center)

http://research.med.miami.edu/clinical-research/ctrs

Research involving the use of UM Clinical Translational Research Site (CTRS) facilities is subject to review by the CTRS prior to receipt of IRB approval. Investigators should upload the CTRS Services Requested Form (available on the CTRS website) to the Ancillary Communication log for all submissions requiring CTRS review.

Contact:
Dr. Joanne Krasnoff
Sr. Manager, Research Support
Clinical Translational Research Site
305-243-2075
j.krasnoff@miami.edu

Jackson Health System – Clinical Research Review Committee (CRRC)

http://www.jacksonhealth.org/clinical.asp

Approval from the JHS-CRRC must be obtained for studies with any research activities (including recruitment of subjects, facilities use, or subject interventions such as tests, measurements, drug administration, surgery, or consenting subjects) occuring at a JHS facility or any studies that involve accessing JHS patient information prior to the use of any JHS resources. Please complete the Jackson Clinical Trials Office Application Form and JHS Study Calendar and upload these documents into the eProst New Study Protocol form when submitting this form to the HSRO.

Contact:
Rosely De Los Santos
Director, JHS Office of Research
Jackson Health System
305-585-7226
Rosely.DeLosSantosPe@jhsmiami.org

University of Miami Hospital (UMH) Research Review Committee

Click to learn more about the University of Miami Hospital (UMH) Research Review Committee.

Approval from the UMH Research Review Committee must be obtained for studies with any research activities occuring at University of Miami Hospital prior to the use of any UMH resources. Please complete the UMH Clinical Research Services/Resources Requested Form and upload these documents into the IRB 7 New Study form when submitting this form to the HSRO.