NIH sIRB Review Policy for Multi-Site Research

On June 21, 2016 the National Institutes of Health (NIH) issued a policy for single Institutional Review Board (sIRB) of NIH-funded human subjects research protocols conducted at two or more U.S. sites. The goal of the policy is to enhance and streamline the IRB review process for multi-site research so that research can proceed as effectively and expeditiously as possible, without diminishing human subjects protections. Minimizing duplicative IRB reviews should also reduce administrative burdens and allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.

What is the new NIH Policy?

The National Institutes of Health (NIH) issued the policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.  The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.

The NIH Single IRB Policy applies to domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human-subjects research whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. The policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018.

What is a Single IRB (sIRB)?

Single IRB models may utilize different reliance models. Typically, a sIRB model can fall into the following two categories:

Central IRB Model (or Ceded Model)

One IRB serves as the IRB of record for all participating sites involved in a multi-site protocol. The IRB of record assumes all responsibilities associated with an ethical review, including initial review, continuing review, and review of all documents.

Shared Model

One IRB serves as the IRB of record for all participating sites involved in a multi-site protocol. The IRB of record approves the study but the local IRB shares in some responsibilities, including conducting local context review.

What are Single IRB (sIRB) Reliance Agreements?

Single IRBs (sIRBs) may also utilize different reliance agreements. Examples of reliance agreements are explained in the table below, although individual campuses may have other arrangements including agreements with private IRBs:
Individual Investigator Agreement (IIA) An agreement used when one institution agrees to serve as the IRB of record for external institutions engaged in human-subjects research who are not affiliated with an institution with its own IRB.
IRB Authorization Agreement (IAA) A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying Institution. Agreements are generally used to cover a single research study, categories of research studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).
SMART IRB Agreement SMART IRB is a national master reliance agreements funded by the National Center for Advancing Translational Sciences (NCATS). It is intended to serve help institutions facilitate the implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multisite Research.

When did the policy go into effect?

January 25, 2018

Why did NIH create a new Policy?

The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.

What NIH grants are affected by the new Policy?

  • All competing grant applications (ie, new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2018.
  • Multi-site studies conducting research in the United States
  • Sites in which the same protocol involving non-exempt human subjects research is conducted
  • Studies supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program

Exceptions: foreign awardees; international sites where proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy; or collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.

What are your responsibilities as the Lead Principal Investigator (PI)?

Checklist for NIH sIRB – Lead PI Guidance & Responsibilities

How many sites can rely on UCI as the IRB of Record?

Generally, up to three (3) different sites / institutions.   Each site must conduct non-exempt human-subjects research for which the same research procedures as UCI are administered.

What are the rates for review?

Please contact the Office of Research to discuss whether UCI’s IRB will act as the sIRB or whether an external IRB would be more appropriate.

Contact:

Valerie Sanchez, MA, CCRP, CIP
IRB Reliance Administrator
(949) 824-7735
IRBReliance@uci.edu