Ancillary Committees

In some cases, research will involve certain activities that require specialized review. For example, when a study involves radiation, the research must undergo review by the Human Use Radiation Safety Committee (HRSC).  

If your research meets the requirements for one of the ancillary reviews below, you must submit the research to that Committee according to the Committee’s requirements.

 

Ancillary review requirements

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Ancillary Committees Information

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Protocol Review and Monitoring Committee-  PRMC

Cancer Related Studies - All cancer related studies (retrospective or prospective) require Protocol Review and Monitoring Committee (PRMC) review and approval prior to IRB review. 

Please submit all study related materials to the PRMC via the PRMC Electronic Submission (PES) Form at PES https://bbcapps.ad.med.miami.edu:8443/PES/login.htm

If you have questions related to the submission, please contact the PRMC via email at sccc.prmc@miami.edu or via telephone at 305-243-6013.

For population science or social behavioral study specific requirements, please contact sbs.prmc.startup@miami.edu for more information.

Additional information on the PRMC and the processes required for cancer related research can be found at Sylvester RCSU https://umiamihealth.org/sylvester-comprehensive-cancer-center/research/research-resources/clinical-research-services/research-committees-support-unit

Possibly Cancer Related

If your study is possibly cancer related and you need clarification or if you have any questions or need information regarding the definition of cancer-related, please contact Simmy Thompson-Lucas via email at sthompson2@med.miami.edu to determine whether the study requires submission to the Protocol Review and Monitoring Committee (PRMC). 


Additional information on the PRMC and the processes required for cancer related research can be found at Sylvester RCSU https://umiamihealth.org/sylvester-comprehensive-cancer-center/research/research-resources/clinical-research-services/research-committees-support-unit


Contact:
Pam Cooper
Manager, Research Support
Sylvester Comprehensive Cancer Center
Phone 305-243-6013
pamela.cooper@med.miami.edu

 



Data Security Ancillary Committee- DSAC

Studies in which data is being shared outside of the University of Miami or being stored in systems not provided and maintained for by the University of Miami may be subject to review by the DSAC prior to receipt of IRB approval. Any studies requiring DSAC approval will be routed to the DSAC by eProst. If DSAC approval is required, you must complete the Research Data Security Assessment Form and upload the form onto the Local Site Documents section on eProst.

Contact: 
Helenemarie Blake-Leger, Esq.
Data Privacy Officer, University of Miami
Chief Privacy & Data Integrity Officer, University of Miami Health System
Office of Privacy and Data Security
305-243-5000
hblake@med.miami.edu

 



Radiation Safety – HRSC

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

Approval from HRSC must be obtained for protocols where radiation/radioactive 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

 



Clinical Trial Disclosure - CTD

Website: https://ctd.uresearch.miami.edu

RCQA created processes and procedures to assist our researchers and their teams in achieving and maintaining adherence with many of the CTD requirements. We offer a university-wide training program, including the basics of CTD related regulations and requirements, in addition to providing one-on-one support for Trial Registration and Result Reporting on https://register.clinicaltrials.gov.  RCQA has also established a university-wide system/database to obtain tracking and metrics of trial registration and result reporting.

Contact:

Yolanda P. Davis, CCRP
Clinical Trial Disclosure Manager
Office of Research Compliance and Quality Assurance 
Phone: (305) 243-0494
E-mail: Y.P.Davis@med.miami.edu

 



Institutional BioSafety Committee- IBC

All clinical trial protocols that propose the use of recombinant DNA, synthetic nucleic acid materials, or a genetically modified organism or therapeutic must receive prior approval from the Institutional Biosafety Committee (IBC).  If you have questions, please contact Ellen Kapsalis, Ph.D. Director Research Compliance at 305-243-2311 or email ekapsali@med.miami.edu.  Please refer to the documents for Human Gene Transfer Research at Institutional Biosafety Committee (IBC) | UResearch | University of Miami.

Approval from IBC must be obtained for studies involving gene transfer.  A Biosafety Ancillary review is required when the answer to the following is “yes.” 

Do any of the materials being used on this study involve recombinant DNA, synthetic nucleic acid materials, or a genetically modified organism?

If the answer is “yes,” your study requires IBC Ancillary review. 

Submissions requiring IBC review will be routed to IBC by eProst. The IRB will review the study concurrently with the IBC but will not issue an approval letter until both the IBC and IRB committees have approved the study.


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

 



Embryonic Stem Cell Oversight Committee – 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 will review the study concurrently with the IBC but will not issue an approval letter until both committees have approved the study. Please visit the ESCRO committee website at https://www.uresearch.miami.edu/uresearch-services/escro/index.html  for further information.

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

 



Office of Environmental Health and Safety – EHS

The purpose of the University's Biological Safety Program is to assist Principal Investigators and research staff safely handle biological agents in the laboratory by implementing a risk assessment process analyzing the agents’ specific risk factors. More information about biosafety can be found at https://ehs.miami.edu/.

Approval from EHS must be obtained for studies involving Biosafety Level 2 (BSL2) and higher agents. Additional review may be required.  A Biosafety Ancillary review is required when the answer to any of the following is “yes.” 

  1. Does this project involve the introduction of foreign biological materials?
    1. Are the materials infectious, toxic, or otherwise RG-2 or higher in nature?

If the answer is “yes,” specify, and fill out the Biosafety Ancillary Risk Assessment form.

  1. Does your work involve the collection of human materials from the patient such as blood, biopsy specimens or other tissues?
    1. Will your lab be manipulating or processing these samples?
    2. Will the specimens be collected and then shipped to another facility for processing?
    3. Are the samples coming from a patient known to carry disease?

If the answer is “yes,” specify, and fill out the Biosafety Ancillary Risk Assessment form.    

The IRB will start review of the study before receiving approval from EHS, but the review is required before study procedures can start.  Please complete and upload the Biosafety Ancillary Risk Assessment form into eProst as required.

Contact:
Shane Gillooly
Biosafety Manager
Office of Environmental Health and Safety
305-243-3269
sxg1519@med.miami.edu

 



Clinical Research Operations and Regulatory Support – CRORS

http://research.med.miami.edu/clinical-research/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, MD, MBA
Director, Regulatory Support
Clinical Research Operations and Regulatory Support
305-243-0493
sgil@med.miami.edu

 

For studies conducted by PIs who are new to clinical research:
Alina Gjerpen
Project Manager
Clinical Research Operations and Regulatory Support
305-243-0492
arg136@med.miami.edu

 



Clinical Translational Research Site – CTRS

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 CTRSprior to receipt of IRB approval. Investigators should upload the CTRS Services Requested Form (available on the CTRSwebsite) to the Ancillary Communication log for all submissions requiring CTRS review.

Contact: 
Halina Kusack, RN, BBM, MSN
Director, Clinical Operations
Office of Clinical Research (OCR)
305-243-7412 (Office)
305-243-5012 (Front Desk)
HXK115@med.miami.edu

 



Jackson Health System – Clinical Research Review Committee – CRRC

https://jacksonhealth.org/clinical/submission/

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: 
Katuska Barbery, MBA
Director of Clinical Research, JHS Office of Research
Jackson Health System
305-585-7226
Katuska.Barbery@jhsmiami.org

 



SCCC Research Lab & Satellites- SCCC

Research involving the use of SCCC Research Lab & Satellites facilities is subject to review by the SCCC lab staff prior to any research lab utilization.

Coordinators should fill out the SCCC Research Lab & Satellites Services Request Form and send it to: ResearchLab&Satellites@miami.edu.

This form must also be uploaded in the Local Site Documents section.


Contact: 

Jull Frank Chica, MBA
Supervisor, SCCC Research Laboratory & Satellites
Office of Clinical Research (OCR)
305-243-1344 (office)
jchica@med.miami.edu

OR


Halina Kusack, RN, BBM, MSN
Director, Clinical Operations
Office of Clinical Research (OCR)
305-243-7412 (Office)
305-243-5012 (Front Desk)
HXK115@med.miami.edu

 



UHealth Tower – UHT

Approval from the UHealth Tower (UHT) Ancillary Committee 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) occurring at UHealth Tower facility or any studies that involve accessing UHT patient information, prior to the use of any UHT resources. Please complete the appropriate form and upload it into Local Site Documents when submitting this form to the HSRO.

Halina Kusack, RN, BBM, MSN
Director, Clinical Operations
Office of Clinical Research (OCR)
305-243-7412 (Office)
305-243-5012 (Front Desk)
HXK115@med.miami.edu

 

 

Pathology

Research in which patient specimen collection occurs at an UM patient care facility including , fluids, frozen , fresh or archived tissues,  archived or slides, and/or Pathology Department expertise, specialty and/or services is required will be reviewed by the Pathology Ancillary Review Committee.  The Pathology Office of Research  will communicate with the study team as to the nuances of their needs and identify how those needs will be met. 


Department of Pathology & Laboratory Medicine
Office of Research
(305)243-9676
Axm2844@med.miami.edu