Ancillary Committees

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.

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

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

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

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

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

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.

IRB ID #: IRBAC008

IITS-U ancillary review is required for new studies involving an IND or IDE held by a University of Miami Investigator and for protocol amendment made to these studies.    

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 policies and procedures as per University 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 14^th Street, Rm. 1238
Ph: 305-243-0493
E-mail: nshank@med.miami.edu

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

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 

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 

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

IRB ID #: IRBAC014

Approval from the JHS-CTO 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. Send the JHS Study Calendar and Workflow (if applicable) 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.

https://jacksonhealth.org/administrative/clinical-trials/

Attached is a checklist for compliance review items from JHS:

  JHS Compliance Checklist

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

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

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