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.

You can also find more information on our Single IRB & Reliances page.

• 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 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.