UM Central Institutional Review Board (UM CIRB)

UM Central Institutional Review Board (UM CIRB)

The UM Central IRB mainly reviews selected multisite projects. This is a non-share central IRB model where UM fulfills all IRB review requirements.

The purpose of the UM Central IRB is to first, enhance the quality of human research protection in multi-site human research projects by performing appropriate ethical and scientific review while ensuring local issues are addressed. Second, it is to enhance the efficiency of reviews across participating sites.

Common Rule and FDA regulations provide for Central IRBs and other cooperative IRB review arrangements (45 CFR 46.114,21 CFR 56.114)

A coordinating center will be appointed as the main point of contact between the lead Principal Investigators (PIs), the local sites and the UM CIRB.

The lead PI who plans to use UM CIRB must add UM Central IRB to its Federalwide Assurance (FWA) and sign an Institutional Authorization Agreement (IAA) with UM. The IAA clearly delineates the respective roles and responsibilities of each entity. Instructions for adding the UM CIRB as an IRB of record, the UM Standard Operating Procedures (SOPs) and forms, a manual detailing the responsibilities of lead investigators, local sites and UM CIRB, and Guidance for local sites in updating their SOPs to incorporate use of the UM CIRB are included below.

UM CIRB Forms & Documents

UM CIRB Manual for Investigators and Networks

IRB Library

IRB Authorization Agreement

Naming Convention

Local Context Review Form for Coordinating Center

Participating Consortia:

CReATe (Clinical Research in ALS and Related Therapeutic Development)

  • OneIRB will serve as the Coordinating Center, managing the flow of documents to and from UM CIRB and the participating sites
    • Collect documents to submit to the Single IRB of Record
      • Study team CVs
      • Documentation of human subjects protection education
      • Informed consent form with local language incorporated
      • Certification of local context review from the local IRB
    • Submit applications to the Single IRB of Record
      • Initial review
      • Modification
      • Continuing Report
      • Reportable New Information such as unanticipated problems or noncompliance
    • Respond to queries from UM CIRB
    • Disseminate UM CIRB approval letters and documents to sites

Fee Schedule

(Link to document coming soon)

UM Central IRB Contact Information

If you are interested in pursuing human subjects research utilizing the UM Central IRB model, please contact the Human Subject Research Office. We will help you determine which model may work best for research.

Evelyne Bital, MA, CIP
Associate Director for Privacy and Regulatory Affairs
ebital@med.miami.edu
305-243-9977

Joseph Datko, MS, CIP
IRB Regulatory Analyst
jad123@med.miami.edu
305-243-9769

Mitscher Gajardo
Sr. IRB Regulatory Analyst
msg101@med.miami.edu
305-243-9242

Aisha Usher, MA, CIP, CCRP
IRB Regulatory Analyst
a.usher@med.miami.edu
305-243-9240

…or email us at hsro@miami.edu