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.

HRP- 309 - Ancillary review matrix

Quick Reference Guide

Ask yoUr Ancillaries

Ancillary Committees

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  • Cancer Protocol Review & Monitoring Committee (CPRMC)

    IRB ID #: IRBAC001

    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 OPERA (Formerly PES)

    Modifications: Protocol updates require PRMC approval if PRMC is listed as an ancillary review committee under the parent study.

    Contact:

    Sandra Rossi
    Manager, Research Support
    Sylvester Comprehensive Cancer Center

    sandrarossi@med.miami.edu

    Questions: 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.

  • Clinical Trial Disclosure Committee (CTD)

    IRB ID #: IRBAC002

    This process facilitates the UM’s compliance 42 CFR § 11, FDAAA Section 801, FDAMA Section 110, CMS, NIH and ICMJE. 

    The CTD Ancillary Committee determines if a study must register on ClinicalTrials.gov.  This determination includes:

    • Is it a clinical trial?
    • Who must register the study on ClinicalTrials.gov?
    • Does the protocol have all the information needed for registration and reporting?
    • Does the informed consent form have the required CTD language?

    Determination and Protocol Registration Policy 

    Clinical Trial Determination Questionnaire

     

    Contact:

    Karre Wetherington, CCRP, CCA
    Sr. Clinical Trial Disclosure Associate
    Regulatory Affairs & Assessment
    Phone: (305) 243-1107
    E-mail: kwetherington@miami.edu

  • Environmental Health & Safety Committee (EHS)

    IRB ID #: IRBAC003

    EHS approval is required for studies that collect patient specimens or introduce risk group 2 agents (or higher) or any recombinant therapeutics.

    Requirement: Complete the Biosafety Ancillary Risk Assessment Form and upload via the Manage Ancillary Reviews activity in IBISResearch-IRB.

    Modifications: All modifications that introduce new risk group 2 agents (or higher) or any new recombinant therapeutics not included in the previous protocol.

    Requirement: Complete the Biosafety Ancillary Risk Assessment Form and upload via the Manage Ancillary Reviews activity in IBISResearch-IRB.

    Adding personnel who will be collecting human specimens, processing samples, or handling risk group 2 (or higher) agents* needs to complete the following courses:

    1) IBC Biosafety Training every three years for Clinical Staff via ULearn

    2) UHealth OSHA's Bloodborne Pathogens, Biomedical Waste, Latex Allergy and TB Training required every year via ULearn

    Contact:

    Primary point of contact:
    BSO_Review@miami.edu

    Secondary Contacts at the Biosafety Office:

    Shane Gillooly
    Biosafety Manager
    305-243-3269
    sxg1519@med.miami.edu

    Quintin James
    qaj3@miami.edu

  • Embryonic Stem Cell Oversight Committee (ESCRO)

    IRB ID #: IRBAC004

    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. 

    Requirement:  Such submissions must be submitted to the ESCRO committee outside of the IRB system.

    Please visit the ESCRO committee website at https://www.research.miami.edu/about/admin-areas/raa/escro/index.html  for further information.

     

    Modifications to the initially approved study approved for embryonic stem cells and/or their derivatives

    1. update to the IB or protocol amendment
    2. protocol closure
    3. RNIs

    Requirement:  Such submissions must be submitted to the ESCRO committee outside of the IRB system. The review process for the ESCRO committee can occur concurrently, but the HSRO cannot release the IRB approval until ESCRO signs off.

    Individuals listed or added onto an ESCRO related protocol must complete an online module via ULearn. complete this training once. Contact: Liz Meza  lmeza@miami.edu  for more information.

    CR review requires ESCRO committee approval.

     

    Contacts:

    Primary point of contact:

    Dr. Ellen Kapsalis
    Director of Compliance
    IACUC / IBC / ESCRO

    ekapsali@med.miami.edu

    Secondary Contact:

    Liz Meza
    Senior Regulatory Analyst
    IACUC / IBC / ESCRO
    lmeza@miami.edu

  • Institutional BioSafety Committee (IBC)

    IRB ID #: IRBAC005

     

    All clinical trial protocols that use recombinant DNA, synthetic nucleic acid materials, or a genetically modified organism or therapeutic must receive prior approval from the Institutional (IBC).

    Requirement: Please refer to the documents for Human Gene Transfer Research at Institutional Biosafety Committee (IBC) | UResearch | University of Miami.

    Such submissions must be submitted directly to the IBC committee outside of the IRB at IBCsupport@miami.edu

    The review process for the IBC and the IRB can occur concurrently, but the HSRO cannot release the IRB approval until IBC signs off.

    Modifications to the initially approved study approved for the use of recombinant DNA, synthetic nucleic acid materials

    1. update to the IB or protocol amendment
    2. Closure of study
    3. RNIs

    Requirement: Please refer to the documents for Human Gene Transfer Research at Institutional Biosafety Committee (IBC) | UResearch | University of Miami.

    Adding personnel for following roles:

    1. Change of PI
    2. sub-investogator
    3. study coordinator
    4. Individuals administering study products (nurses, etc.)

    Lab personnel handing study product:

    Biosafety Training is required every three years for all research personnel and for new personnel added to the study during the research.  Personnel includes anyone involved with the material/agent (whether administrating it or collecting samples or transporting the material across campus).

    This training is available via ULearn as a module titled “IBC Biosafety Training for Clinical Staff”.

    IBC NIH Guidelines Training (must be completed once) by PIs, sub-investigators, co-investigators.

    This training is a PowerPoint presentation. Contact IBCsupport@miami.edu for review and credit. 

    CR review requires ESCRO committee approval.

     

    Contacts:

    Primary point of contact:

    IBCsupport@miami.edu

    Secondary Contact:

    Liz Meza
    Senior Regulatory Analyst
    IACUC / IBC / ESCRO
    lmeza@miami.edu

  • Human Use Radiation Safety (HRSC)

    IRB ID #: IRBAC006

    Protocols where radiation/radioactive materials (not MRI, Ultrasound or Laser Treatment) or radiation producing devices are being used for research purposes

    Modifications that introduce radiation/radioactive materials (not MRI, Ultrasound or Laser Treatment) or radiation producing devices to the parent study

     

    Contact:

    Sean O. Wilson
    Radiation Safety Officer
    305-243-6360
    sow10@med.miami.edu

    Diana R. Hernandez
    Radiation Control Manager
    305-243-6360
    drh85@med.miami.edu


  • Conflict of Interest Committee (COIC)

    IRB ID #: IRBAC007

    The UM COI Committee acts to determine, through a risk-based, case-by-case review, whether a COI is created between a research project and an external relationship. If a COI is found, the COI Committee works with the investigator to develop a management plan.

    Requirement: Complete the disclosure process in the UDisclose System.

    All investigators are required to complete UM’s disclosure process and COI training prior to engaging in Scholarly Activities, repeated annually.

     

    Contact:

    Lory Hayes, Ph.D.

    Director of DSAM (Disclosures & Scholarly Activities Management) LHayes@miami.edu

    Call the UDisclose System helpline (305-243-0877) with questions about UM’s COI policy or disclosure requirements.

  • Clinical Research Operations and Regulatory Support (CRORS)

    IRB ID #: IRBAC008

    CRORS ancillary review is required for new studies involving an investigator-held IND or IDE and for amendments to the studies.    

    Before the initial ancillary approval, the PI must contact CRORS for a monitoring cost estimate and to discuss the monitoring plan for the study. 

     

    Contacts:

    For New PI’s:

    Alina Gjerpen
    Project Manager, Research and Innovative Medicine
    Clinical Research Operations and Regulatory Support
    305-243-0492
    arg136@med.miami.edu

    For CRORS QC Monitoring:
    Nicole S. McCullough, MS, CCRP
    Director, Clinical Research Operations & Regulatory Support (CRORS)
    University of Miami, Miller School of Medicine
    Dominion Towers, 1400 N.W 10th Avenue, 1005L
    Ph: 305-243-0493
    Fax: 305-243-5392
    E-mail: nshank@med.miami.edu

     

  • Data Security Ancillary Committee (DSAC)

    IRB ID #: IRBAC009

    Studies collecting, storing, and transmitting protected health information (PHI).

    Forms:
    Research Data Security Assessment Form 

    For information on the review process for data privacy plans, please see SOP-HB-008-01

    Contacts:

    Primary point of contact:
    dsac@miami.edu

    Secondary Contact:

    Joey Casanova, BBA
    Data Broker Manager
    305-243-2631

    jcasanova@miami.edu

  • UHealth Tower (UHT)

    IRB ID #: IRBAC010

    UHT Ancillary Committee approval must be obtained for studies with any research activities at a UHT facility or any studies accessing UHT patient information, before using any UHT resources including subject recruitment, facility use, subject interventions such as tests, measurements, drug administration, surgery, or obtaining subject consent. UHT Ancillary Approval is required to determine feasibility of UHT Departments for clinical study protocols. Additional information regarding the UHT review process can be found here:  UHT Ancillary Review Flowchart 

    Requirement: Please complete the UHT Research Request form in the Link below: https://redcap.link/UHTResearchServices and upload via the Manage Ancillary Reviews activity in IBISResearch-IRB.

    Modifications that are adding UHT to the study

    Requirement:  Please complete the UHT form

    Research Request form: https://redcap.miami.edu/surveys/?s=HKP9E74X7ACHTMDM and upload via the Manage Ancillary Reviews activity in IBISResearch-IRB.

     

    Contacts:

    Oncology Protocols

    Mitchell Diaz MSN, AGPCNP-BC
    Inpatient Research Nurse Specialist – Hematology/Oncology
    University of Miami Hospital and Clinics
    UHealth Tower
    O (305) 912-4633
    mxd1433@miami.edu

    Danny Pino BSN, RN, OCN, BMTCN
    Inpatient Research Nurse Specialist – Hematology/Oncology
    University of Miami Hospital and Clinics
    UHealth Tower
    O (305) 912-4633
    d.pino2@umiami.edu

     

    Non-Oncology Protocols

    Carlos Sandoval 
    Director, CTRS Research Operations  
    Miami Miller School of Medicine 
    Office of the Executive Dean for Research - EDR 
    Office: (305)243-8842 

     

  • Clinical Translational Research Site (CTRS)

    IRB ID #: IRBAC011 

    Research protocols using the EDR Clinical Translational Research Site (CTRS) facilities must be  reviewed by the CTRS Ancillary Committee. 

    CTRS Provides the following services:

    Clinical Services (Nursing, Pharmacokinetics, Jackson Memorial Hospital Clinical Research Nursing Support, Laboratory processing, Clinical Study procedures, In-Patient and Outpatient Clinical Services)

    Clinical Research Coordinator Services (Consenting, Screening, Recruitment, Study visits, Documentation and data entry)

    Requirement: Investigators should complete the CTRS Services Requested Form

    Contact:

    Carlos Sandoval 
    Director, CTRS Research Operations  
    Miami Miller School of Medicine 
    Office of the Executive Dean for Research - EDR 
    Office: (305)243-8842 

  • Pathology Review Committee (RPSC)

    IRB ID #: IRBAC012

    All research studies using human samples including bodily fluids (blood, urine, ascites, saliva), and/or biospecimens not limited to frozen tissue, fresh tissue, or archived tissue (paraffin embedded/FFPE), and/or slides must be reviewed by the Department of Pathology and Laboratory Medicine. 

    Review by pathology ancillary review committee is required to process all  requests using human samples for research.

    Please fill out the form using this link: PRC Form.
    The Department of Pathology and Laboratory Medicine has 2 human research cores: Translational Research Histopathology Laboratory (TRHL) and Laboratory of Clinical Biosciences (LCB). Pathology Ancillary Review approval is required before placing iLab requests.


    Modifications: Protocol change affecting Lab samples

    Contact:

    Omar Aljuboori
    Translational Research Scientist
    Department of Pathology
    305-243-9453
    oxa335@miami.edu

     

    Secondary Contact:

    Sophie Egea, PhD
    Director, Clinical Research
    Department of Pathology and Laboratory Medicine
    Research Mailbox: DPLMresearch@med.miami.edu

  • Clinical Research Laboratory Services (formerly known as SCCC Research Lab & Satellites- SCCC)

    IRB ID #: IRBAC013

    Research using Clinical Research Laboratory Services (formerly known as SCCC Research Lab & Satellites) facilities must be reviewed by the CRLS lab staff prior to any research lab utilization.

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

     

    This form must also be uploaded via the Manage Ancillary Reviews activity in IBISResearch-IRB.

    Allie Bivin-Martinez
    Director, CRLS
    305-243-6618 (office)
    scccresearchlab@med.miami.edu

     

  • Jackson Health System – Clinical Research Review Committee (CRRC)

    IRB ID #: IRBAC014

    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) occurring 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 upload to the IRB system via the Manage Ancillary Reviews activity, and send the JHS Study Calendar and Workflow (if applicable) directly to the CTO. Please refer to FAQs regarding footer requirements.

    Description of forms*

    Pre-Approval

    JHS Clinical Trials Office Application

    JHS Study Calendar

    JHS Research Request form for JHS’ Electronic Medical Record access

    Pathology By-Pass Letter

    Pathology Research Fee Schedule

    Workflow

    Pre-Submission Feasibility/Budget Request

    Retrospective Chart Review Data Request Questionnaire

    Post-Approval

    Monthly Enrollment Report Form

    PACS. Research Request Form

    Pathology Research Fee Schedule

    Patient Chart Review Form

    *Ongoing updates/ revisions forthcoming in this space as part of larger inter institutional commitment between JHS and UM.

    For general inquiries email: JHS-CTO-Submissions@jhsmiami.org

    For EMR access, Data requests, ClickUp access email: JHS-CTO-Research-Tickets@jhsmiami.org

    Additional EMR training could be located at: Jackson Health System Online Orientation (jhsmiami.org)

    If you have any questions regarding use of the forms and process, please contact:

    JHS-CTO-Submissions@jhsmiami.org
    JHS Clinical Trials Office
    Jackson Health System
    305-585-7226

     

  • MCA Review Group (ORA)

    IRB ID#: Pending

    All Submissions where question #5 in “Study Scope” is answered “yes”. The purpose of this review is to confirm if a Medicare Coverage Analysis (MCA) is needed.

    ORA will be reviewing correctness of this answer to ensure compliance with Clinical Management (CTM) and participant Enrollment and Tracking Policy.

    If answer is Yes, study will be tracked for billing in Velos by CRRC and MCA must be available in Velos.

    If answer is No, study will not be tracked for billing in Velos and MCA is not needed.

    ORA will provide feedback on whether or not question 5 was answered correctly and provide recommendation on required actions as applicable.

    Action above would ensure compliant research billing and eliminate the requests for unnecessary MCAs.

    Contact:

    Tatyana Vikhlyantseva
    Director, Research Administration
    TVikhlyantseva@med.miami.edu
    305-284-3942

    Bianca Krysztof
    Sr. Manager, Research Administration
    b.gjorgievski@miami.edu
    305-284-1735

    Amy Gonzalez
    Sr. Contract and Grants Analyst
    aeg183@miami.edu
    305-284-3509

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