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Ancillary Committee Information



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The following Ancillary Committees require review and approval before submitting to the Human Subjects Research Office: 



prc

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: Emily Dolezal
             Director, Research Support
             Sylvester Comprehensive Cancer Center

             Phone 305-243-1260
             e.dolezal@med.miami.edu



pprc

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



hrsc

Radiation Materials - Radiation Safety (HRSC)

http://facilities.med.miami.edu/x38.xml 

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



ibc

Recombinant DNA Materials - Institutional BioSafety Committee (IBC)

http://uresearch.miami.edu/default.asp?p=177

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



escro

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

http://uresearch.miami.edu/default.asp?p=178

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



ehs

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


gcrc

Clinical Research Center (CRC)

http://uresearch.miami.edu/default.asp?p=269

Research involving the use of UM Clinical Research Center (CRC) facilities is subject to review by the CRC prior to receipt of IRB approval. Investigators should upload the CRC Services Requested Form (available on the CRC website) to the Ancillary Communication log for all submissions requiring CRC review. Please visit the CRC website at http://uresearch.miami.edu/default.asp?p=269&s=30 further information.

Contact: Dr. Joanne Krasnoff
             Sr. Manager, Business Operations
             Clinical Research Center
             305-243-2075 - j.krasnoff@miami.edu



rsqa

Regulatory Support and Quality Assurance (RSQA)

http://uresearch.miami.edu/?p=376&s=43

Review and approval from the RSQA Quality Control 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 RSQA QC ancillary committee will not review continuing/final reports.

Contact:  Ann Glasse, RN, BSN, MBA
               Director, Regulatory Support
               Office of Regulatory Support and Quality Assurance
               305-243-0133 - AGlasse@med.miami.edu 



jhs

Jackson Health System - Clinical Research Review Committee (CRRC)

http://jhsmiami.org/body.cfm?id=9642

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 the JHS Study Calendar and upload these documents into the eProst New Study Protocol form when submitting this form to the HSRO.

Contact: Eve Sakran
             JHS-CTO Director
             Jackson Health System
             305-585-7596 - esakran@jhsmiami.org



Ancillary Committee Documents



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