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

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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

    Clinicaltrials.Gov Registration Ready Departmental Protocol Review Checklist

     

    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

    Sijan Poudel 
    Biosafety Specialist and primary IRB reviewer 
    305-934-5967 
    sxp868@miami.edu 


    Melanie Peapell 
    Biosafety Specialist 
    305-389-9931 
    MPeapell@med.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 CITI. 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 IBC 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 involving the use of radiation or radioactive materials, including MRI, high-intensity focused ultrasound (HIFU), and theranostic research studies, are utilized for research purposes 


    Modifications that introduce radiation or radioactive materials, including MRI, high-intensity focused ultrasound (HIFU), and theranostic research studies, are utilized for research purposes 

    Contact:

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

    Maxwell Amurao, PhD, DABR 
    Executive Director, Radiation Safety Officer 
    305-243-6360 
    mxa5672@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 COI training and 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.

  • Investigator Initiated Trial Services at the U (IITS-U) Miller School of Medicine

    IRB ID #: IRBAC008

    IITS-U ancillary review is required for new studies involving an IND or IDE held by a University of Miami Investigator.  

    Before the initial ancillary approval, the PI should contact IITS-U (iitsu@miami.edu) to discuss the monitoring plan for the study.  

    In addition, IITS-U coordinates training for new PIs to ensure that new PIs conducting their first interventional clinical trial at the University are aware of their responsibilities to satisfy federal regulations and University requirements (policy HSR-P-001). 

    Contacts:

    For New PI’s:

    Alina Gjerpen
    Project Manager, Regultory Support
    Investigator Initiated Trial Services at the U
    arg136@med.miami.edu

    For IITS-U QC Monitoring:
    Nicole S. McCullough, MS, CCRP
    Director, Regulatory Support 

    Investigator Initiated Trial Services at the U
    Executive Dean for Research
    University of Miami, Miller School of Medicine
    Don Soffer Clinical Research Center, 1120 NW 14th Street, Rm. 1238
    Ph: 305-243-0493
    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

    https://redcap.miami.edu/surveys/?s=HKP9E74X7ACHTMDM  

    To ensure proper oversight and resource allocation, all research studies must obtain approval from the UHT Ancillary Committee if they involve: 

     

    • Conducting any research activities within a UHT facility. 
    • Accessing sensitive UHT patient information. 
    • Utilizing any of the following UHT resources: 
    • Recruiting research subjects 
    • Using UHT facilities 
    • Performing interventions on subjects (such as tests, measurements, drug administration, or surgery) 
    • Obtaining informed consent from subjects 

     

     

    • Please complete the UHT Research Request form using the link provided:   

    https://redcap.miami.edu/surveys/?s=HKP9E74X7ACHTMDM  

    • Upload it via the Manage Ancillary Reviews activity in IBIS Research-IRB.   
    • Modifications that involve adding UHT to the study should be uploaded via the Manage Ancillary Reviews activity in IBIS Research-IRB. 

      

    Contacts: 
    Oncology Protocols 

    Natacha Innocent MSN-ADM, RN, CCRP  
    Inpatient Research Nurse Specialist  
    Hematology & Medical Oncology  
    Oncology Inpatient Services 
    University of Miami Hospital and Clinics  
    UHealth Tower  
    nxi71@med.miami.edu 

     

    Deborah Duya, BSN, RN 
    Inpatient Research Nurse Specialist – Hematology/Oncology  
    University of Miami Hospital and Clinics 
    UHealth Tower 
    dxd1001@miami.edu 
    305-912-4633 

     

    Non-Oncology Protocols  

    Carlos Sandoval, MSc, MA 
    Director of Clinical Research Operations | CTRS 
    Office of the Executive Dean for Research 
    University of Miami Miller School of Medicine 
    c.sandoval1@med.miami.edu 
    305-243-8842 

     

  • Clinical Translational Research Site (CTRS)

    IRB ID #: IRBAC011 

    https://redcap.miami.edu/surveys/?s=JKRHEWWKAHHMJERJ  

    To ensure the successful execution of your research, protocols utilizing the EDR Clinical Translational Research Site (CTRS) facilities require review by the CTRS Ancillary Committee. This step helps align our resources with your study's needs. 

     

    CTRS offers a robust suite of services designed to facilitate your clinical research study execution.  https://med.miami.edu/research/clinical-research/ctrs  

     

    • Comprehensive Clinical Services: We provide essential support, including nursing care, pharmacokinetic analysis, laboratory processing, and the execution of clinical study procedures. This encompasses both inpatient and outpatient clinical services and collaboration with Jackson Memorial Hospital Clinical Research Nursing Support. 
    • Dedicated Clinical Research Coordinator Services: Our coordinators can assist with essential tasks such as participant consent, screening, recruitment, coordinating study visits, and detailed documentation and data entry. 
       
      Please complete the CTRS Request form using the link provided:   
    • Upload it via the Manage Ancillary Reviews activity in IBIS Research-IRB.   
    • Modifications that involve adding CTRS to the study should be uploaded via the Manage Ancillary Reviews activity in IBIS Research-IRB. 

     

     

    Contact: 

    Carlos Sandoval, MSc, MA 
    Director of Clinical Research Operations | CTRS 
    Office of the Executive Dean for Research
    University of Miami Miller School of Medicine 
    c.sandoval1@med.miami.edu 

     

    Luzedy Ocasio, BSN, RN 
    Clinical Research Nurse III | CTRS 
    Office of the Executive Dean for Research 
    University of Miami Miller School of Medicine 
    lxo251@med.miami.edu  
    305-243-2877 

     

  • 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 FormAdd the completed form as an attachment to the Ancillary Review in IBISResearch 
    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:

    Maria T. Bertoli 
    Clinical Research Manager 
    Department of Pathology and Laboratory Medicine 

     

    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,  sxl4464@med.miami.edu, and cxm2443@med.miami.edu.

    If study is deemed feasible, a budget for the study will be submitted within 2 weeks of feasibility determination. 

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

    Shaddai Lopez 
    Director, CRLS 
    305-243-6618 (office) 

    305-243-5232 (lab) 

    sxl4464@med.miami.edu (Lab Director E-Mail) 
    scccresearchlab@med.miami.edu (General Lab E-Mail) 

     

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

    IRB ID #: IRBAC014

    Approval from the JHS-ORA must be obtained for studies with any research activities (recruitment of subjects (including posting flyers), facilities use,  subject interventions such as tests, measurements, obtaining samples, drug administration, surgery, or consenting subjects) occurring at a JHS facility or any studies that involve accessing JHS patient records  prior to the use of any JHS resources. Please complete the JHS Office Research Form and upload to the IRB system via the Manage Ancillary Reviews activity. Send the JHS Study Calendar and Workflow (if applicable) Workflow-Template.pdf directly to the CTO submissions inbox JHS-CTO-Submissions@jhsmiami.org. Please refer to FAQs regarding footer requirements. 

      

    For research involving JHS, kindly refer to their webpage for the most comprehensive/ real time information. 

    Office of Research | Jackson Health System Attached is a checklist for compliance review items from JHS: 

      JHS Compliance Checklist 

      

    For inform consent submission requirements:

    For JHS studies:

    • Submit a signed and dated Research Informed Consent (ICF) and HIPAA authorization to the ClinicalTrialsOffice@jhsmiami.org  within 2 business days of consenting the patient, to comply with JHS Policy 802: “Participant Enrollment & HIPAA Authorization Notification” and JHS Office of Research Application attestation.
    • Submit a Research Encounter Ticket (RET) within 2 business days of the patient’s visit, to comply with JHS Policy 803.

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

    JHS-CTO-Submissions@jhsmiami.org 
    JHS Office of Research Administration 
    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

    Yolanda Miranda 
    Sr. Contract and Grants Analyst 
    YMiranda2@med.miami.edu   
    (305) 284-4163 

    Rebecca Carrasco  
    Sr. Contract and Grants Analyst 
    rmc198@med.miami.edu  
    (305) 2438156 

  • Cellular Therapy Lab

    IRB ID #: IRBAC0120

    All clinical trial protocols involving recombinant DNA, synthetic nucleic acid materials, genetically modified organisms, or gene-based therapeutics require Cell Therapy Lab Ancillary Review. Detailed information can be found in the decision tree.

    Prior approval from the Cellular Therapy Interest Group must be obtained before using the service.

    Transplantation & Cellular Therapy (TCT) Investigators will evaluate the study protocol, including risk assessments, intended clinical applications, and oversight measures.

     

    Modifications requiring CLT review:

    - Introducing new cellular therapy products/infusion or transplant product/infusion not included in the previous protocol or IB.

    - Adding personnel for following roles:
    1. Change of PI
    2. Sub-investigator

     

    Contacts:

     

    Dr. Cara Benjamin

    Director, Cellular Therapy Lab

    c.benjamin3@med.miami.edu

    O:(305) 243-5534

    F: (305) 243-3408

    Teams

     

    Veronica Reed

    Medical Technologist 3

    vxr267@med.miami.edu

    (305) 243-4168

     

     

    Questions or Concerns:

    CTL_ClinicalTrials@med.miami.edu

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