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.
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.
UM CIRB aims to do the following:
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.
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.
The NIH Policy became effective January 25, 2018 and applies to the following: 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: 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: Exceptions to the revised Common Rule regulation include the following: More information about the revised Common Rule regulation as it relates to UM CIRB will be posted as it becomes available.
Central IRB Single IRB Review IRB of Record Relying Institution IRB Authorization Agreement
The terms Central IRB and single IRB may be used interchangeably. Both refer to the process of one IRB that reviews multi-site research.
A term from the NIH policy that that allows one IRB to review the research on behalf of other institutions.
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.
The relying institution is the institution that cedes review responsibilities to the IRB of Record.
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.
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.
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. 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.For currently approved, ongoing NIH-funded multi-site research:
For new NIH-funded multi-site research, yet to be IRB approved:
After the grant is funded, the lead PI must:
UM CIRB currently offers orientation, training, and resources to liaisons or coordinating centers working with University of Miami research teams.
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:
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. Mabel E. Algeciras, PhD
Evelyne Bital, MA, CIP
Associate Director Reliant Review
ebital@med.miami.edu
305-243-9977
Joseph Datko, MS, CIP
Sr. IRB Regulatory Analyst
jad123@med.miami.edu
305-243-9769
Odetta Clarke, MFA, MA, JD, CIPP/US
IRB Regulatory Analyst
odetta.norton@med.miami.edu
305-243-8304
IRB Regulatory Analyst
malgeciras@med.miami.edu
305-243-9240