UM Central IRB

NIH’s single IRB policy intends to reduce administrative obligations and inefficiencies in the multi-site review process, while providing proper protection for human subjects. The UM CIRB can fulfill all IRB review requirements for sites participating in multi-site research.

As with the other IRBs that UM operates, human subject research conducted under the oversight of the UM CIRB must meet high ethical and scientific standards. The Common Rule and FDA regulations provide for Central IRBs and other cooperative IRB review arrangements and provide the regulations under which we operate (45 CFR Part 46.114 & 21 CFR Part 56).

NIH has provided specific guidance regarding multi-site research under a single IRB, available here.

Who We Are

The UM CIRB consists of a dedicated and experienced regulatory team equipped to facilitate the review process for multi-site research and offer support to investigators and institutions.

What We Do

UM CIRB aims to do the following:

• Enhance the quality of human subject protection in multi-site research by performing appropriate ethical and scientific review.
• Ensure the resolution of any local context issues.
• Assist UM investigators conducting or involved in multi-site research.
• Facilitate the efficiency of reviews across participating sites.

Who We Serve

The UM Central IRB mainly reviews multi-site research studies. These studies are generally NIH funded, but investigators may also request to use UM CIRB for non-federally-funded, multi-site studies.

UM investigators interested in working with UM CIRB for their NIH-funded multi-site research should contact Evelyne Bital at 305-243-9977 or via email at ebital@med.miami.edu for more information.

• What is the NIH Single IRB Mandate?

  The single IRB mandate is a NIH policy for the use of a single IRB (sIRB) for non-exempt human subject research, funded by the NIH. UM CIRB is a sIRB.

  The policy applies to all competing grant applications whether these applications are new, renewals, revisions, or resubmissions. Ongoing, non-competing awards will not be expected to comply with this policy, unless the grantee submits a competing renewal application.

  This policy is intended to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising protections for human research participants.

  Additional announcements will be forthcoming, including revised reliance agreement guidance, a cost and fee schedule, information regarding the Smart IRBexchange and further updates to eProst to accommodate the Central IRB process, as well as other related topics.

• What is the impact of the NIH Policy and the new Common Rule Regulation on single IRBs?

  The NIH Policy became effective January 25, 2018 and applies to the following:

  • Research studies funded through grants, cooperative agreements, contracts, or the NIH Intramural Research Program;
  • Non-exempt human subjects research;
  • Multiple sites, all of which are conducting the same protocol; and
  • All competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018.

  Unless local review is required by FDA regulations, interventional multi-site studies under an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) conducted at domestic sites must also use a single IRB.

  Exceptions to the NIH policy include the following:

  • International sites;
  • VA sites; or
  • Sites involving tribal nations.

  Please note that all competing NIH grant applications (new, renewal, revision, or re-submission) with submission dates on or after January 25, 2018 must include a plan describing the use of a sIRB for the study.

  The revised Common Rule regulation becomes effective January 19, 2020 and applies to the following:

  • Federally funded cooperative research, specifically, studies that involve more than one institution.

  Exceptions to the revised Common Rule regulation include the following:

  • International sites;
  • VA sites; or
  • Sites involving tribal nations.

  More information about the revised Common Rule regulation as it relates to UM CIRB will be posted as it becomes available.

• What are some commonly used terms?

  Central IRB
  The terms Central IRB and single IRB may be used interchangeably. Both refer to the process of one IRB that reviews multi-site research.

  Single IRB Review
  A term from the NIH policy that that allows one IRB to review the research on behalf of other institutions.

  IRB of Record
  The IRB of record is the IRB that is designated to review the research study and all following submissions and make the required regulatory determinations. An IRB of Record is also called a Reviewing IRB.

  Relying Institution
  The relying institution is the institution that cedes review responsibilities to the IRB of Record.

  IRB Authorization Agreement
  IRB Authorization Agreement, also called an IAA, or a Reliance Agreement, is a document signed by two or more institutions engaged in human subjects research that permits one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site. IAAs last for the duration of the research and do not need to be updated unless the PI, or study information, changes or an expiration date is provided.

• What are the benefits of the Central IRB?

  The use of a single IRB of record for multi-site studies where each site will conduct the same protocol will help streamline the IRB review process and remove redundancy in the review of such studies. The policy will allow research to proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.

• Who can serve as the single IRB?

  Generally, the lead PI, in collaboration with the IRB office at the lead PI’s institution, will select the single IRB and the NIH must concur with the selection. The selected IRB must be willing to serve as the sIRB. All of the participating sites must agree to rely on the single IRB. 

  Any IRB with a Federalwide Assurance (FWA), or registration, filed with the Office for Human Research Protections (OHRP) can serve as a single IRB.

• How will the NIH single IRB Mandate Impact UM Investigators and Research Teams?

  For currently approved, ongoing NIH-funded multi-site research:

  There will be no action required. Ongoing NIH-funded multi-site research will continue to be reviewed both at UM and the participating sites’ IRBs for modifications and annual renewals until a competitive renewal is required to secure continued funding for the research after January 25, 2018.

  For new NIH-funded multi-site research, yet to be IRB approved: 

  Investigators planning to submit NIH-funded multi-site research after the implementation deadline must plan appropriately for Central IRB review. If the research will be led by a UM investigator and the UM IRB will be the reviewing IRB, the lead PI must consult with UM CIRB.

  The lead PI will be required to assign a coordinating center, or IRB liaison, for the study. This person or group will be responsible for the initial IRB submission, as well as subsequent modification submissions. A modification submission is required in order to on-board participating sites who have ceded review to UM CIRB. The liaison will have primary responsibility for tracking and managing information from the relying institutions. The liaison, or coordinating center, manages all eProst submissions.

• How Do I Request for UM to Serve as the Single IRB of Record?

  1. Contact the UM CIRB team to discuss your plan to use UM as the central IRBfor a multi-site study. A meeting will be scheduled to discuss the details of the study and the study sites. You will be asked to provide information about the funding source, the number of sites requesting UM IRB oversight, the risk level of the study, and the use of drugs and devices in the research. The UM CIRBwill use this information to determine if they are willing to act as the IRB of record.
  2. If the UM CIRB determines it is willing to act as IRB of Record, a letter of support will be provided to the study team. A follow-up meeting will be scheduled to discuss further details of the study, study sites, and the requirement for a CIRB liaison or coordinating center.

  After the grant is funded, the lead PI must:

  1. Alert the UM CIRB that you have received funding and are ready to begin the process of establishing the UM CIRB review for all sites.
  2. Identify and appoint the liaison, or coordinating center. The coordinating center, or liaison, will be required to complete a “Site Details Form” for each site that will rely on UM CIRB. The form will collect information about the relying institution and the local investigator’s responsibilities for oversight of the research activities at each site. Please submit completed forms to the UM CIRB.
     UM CIRB currently offers orientation, training, and resources to liaisons or coordinating centers working with University of Miami research teams.
  3. Execute the IRB Authorization Agreements between the sIRB and sites. The IAA, or reliance agreement, documents the arrangement and establishes expectations about communication, reporting, and procedures. Each participating site will need to establish an IAA with UM CIRB. The coordinating center, or liaison, will work with the lead PI and UM CIRB to facilitate this process.
     The final version of the Agreement will be sent to all sites for signature by their PI and appropriate officials and, once signed, returned to UM CIRB. The UM Institutional Official will then sign the agreement, and copies of the executed agreement will be sent to all relying sites. The University of Miami has signed a Master Reliance Agreement called the SMART IRB Agreement. The SMART IRB is a flexible, national IRB reliance agreement that may be used by the University of Miami community. The SMART IRB agreement provides complementary tools and resources to help eliminate the need to establish a study-specific agreement. 
     Reliance agreements for single IRB review are used to cede ONLY the IRB review of protocols. All institutionally required ancillary reviews such as Conflict of Interest, Radiation Safety, Embryonic, Stem Cell, or IND/IDE oversight must still be reviewed and approved locally.

  After the reliance agreement is executed:

  1. After the reliance agreement is executed, the coordinating center, or liaison, must formally submit the study to the UM CIRB. The coordinating center, or liaison, will also be involved in a key role as the study progresses.
     1. Submission
        1. The coordinating center, or liaison, submits the generic protocol, consent and recruitment materials for review to UM CIRB.
        2. The coordinating center, or liaison, submits site-specific information such as investigator qualifications, site-specific recruitment and consent information, and other local context information e.g., state laws about the age of majority, for review to the UM CIRB.
        3. Once the study is approved, UM CIRB approved materials will be available in eProst for distribution to relying sites. The coordinating center, or liaison, will be responsible for disseminating information across the relying sites.
     2. Continuing Reviews
        1. At time of annual renewal, the coordinating center, or liaison, gathers continuing report data from all relying sites and submits a summary report through eProst.
     3. Modifications
        1. The coordinating center, or liaison, submits modifications and reportable events for all sites through eProst and disseminates any UM CIRB determinations.

• How do I request a reliance consultation?

  If you are interested in pursuing human subjects research using the UM CIRB model, please contact the Human Subject Research Office. We will guide you through the process.
  
  Evelyne Bital, MA, CIP
  Associate Director for Privacy and Regulatory Affairs
  ebital@med.miami.edu
  305-243-9977
  
  Mabel E. Algeciras, PhD
  IRB Regulatory Analyst
  malgeciras@med.miami.edu
  305-243-9240

  Michelle Guzman, BFA, RPSGT
  IRB Regulatory Analyst 
  mxg1836@med.miami.edu
  305-243-9242