Project:

Single IRB

overview icon Overview

Use of Single IRBs for Multicenter Clinical Trials

For nearly a decade, CTTI has championed the adoption of single IRBs (sIRBs) for multicenter clinical trials. We have developed a number of recommendations and other resources to address barriers to and drive adoption of sIRB implementation.

 

Today, in light of recent mandated changes to the use of sIRBs in multicenter clinical trials, CTTI is building on past work by collaborating with an NIH workgroup to develop a comprehensive plan for assessing the NIH's sIRB policy. We are also developing resources to assist researchers and institutions in implementing the sIRB model.

 

CTTI also showcases studies that have successfully implemented use of a sIRB, such as IMPACT-AFib, a nationwide pragmatic trial launched by collaborators including CTTI.

 

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Discover Additional Deliverables Generated From This Project

Expert Meeting

Meeting Brief

Resource

Single IRB: Institutional Engagement Definitions

Tool

Single IRB: Institutional Engagement Scenarios

Project Summary

Summary of CTTI's Single IRB Projects

Tool

Template IRB Authorization Agreement (IAA): Intended to address an administrative concern about using a single central IRB

Webinar

NIH Collaboratory Grand Rounds on Advancing the Use of Central IRBs for Multi-center Trials by Cynthia Hahn

Expert Meeting Materials

Materials, including the executive summary and presentations, from the Expert Meeting held on June 12 - 13, 2014

Webinar

Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

Webinar

Sponsors' Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

Presentation

An Update on the CTTI Use of Central IRBs for Multi-center Clinical Trials Project - Presented November 2013 at the PRIM&R 2013 Advancing Ethical Research Conference

External Communications

Blog Post by BIOTechNOW: CTTI: use of central IRBs in multi-center trials to streamline clinical research

Publication

Check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE. Use of central institutional review boards for multi-center clinical trials in the United States: A review of the literature. Clin Trials. 2013; 10(4): 560-567.

Publication

Flynn KE, Hahn CL, Kramer JM, Check DK, Dombeck CB, Bang S, Perlmutter J, Khin-Maung-Gyi FA, Weinfurt KP. Using central IRBs for multi-center clinical trials in the United States. PLoS One. 2013; 8(1): e54999.

Press Release

Conducting Multi-Center Trials: New Recommendations and Tool for Research

Project Report

Final Report of CTTI's first Central IRB Project

Poster

Use of Central IRBs for Multi-center Clinical Trials - Presented December 2012 at the PRIM&R 2012 Advancing Ethical Research Conference

Expert Meeting Materials

Materials, including the executive summary and presentations, from the Expert Meeting held on April 25-26, 2012

“Using a single IRB for multi-site clinical research is an important step in accelerating the translation from discoveries to health benefits. The Clinical and Translational Science Awards (CTSA) program is working toward using a single IRB for multi-site studies. The CTTI Central IRB recommendations will be very helpful in advancing towards this goal.”

Petra Kaufmann M.D., M.Sc. Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS), NIH

On December 3, 2014, the National Institutes of Health (NIH) issued a draft policy for the use of single IRBs in multi-site clinical research studies, citing a CTTI publication. The final NIH policy and single IRB mandate went into effect Jan. 25, 2018.

“The National Cancer Institute is moving toward the NCIRB being the sole IRB of record and we are starting to see many sponsors require central IRB review as more institutions are coming on board and becoming comfortable with the model.”

Cynthia Hahn Chief Operating Officer, Feinstein Institute for Medical Research

"We implemented the CTTI recommendations within our company and made a commitment that all sponsors of clinical trials would be reviewed by a central IRB.”

Soo Bang Senior Director, Business Development and Global Alliances, Celgene Corporation

“We think that there is a lot of merit in supporting improvements in the clinical trial infrastructure itself. The Clinical Trials Transformation Initiative has contributed so much in terms of innovative trial design, as it is working on establishing centralized IRBs for multicentered trials, which is an important advancement.”

Margaret A. Hamburg, MD former Commissioner, FDA

Page 1 Project Progress

Identify Research Impediments
100%
Gather Evidence
100%
Analyze & Interpret Findings
100%
Develop Recommendations
100%
Disseminate & Implement
100%

in detail icon In Detail

Before a clinical trial begins, the study protocol needs to be reviewed by an impartial third party (usually an IRB) to ensure ethical rigor and to determine that the study provides potential benefits and prevents unnecessary harm to participants. In a multicenter trial (i.e., a study that investigates a single research question at several different sites/locations), each site’s IRB (often referred to as a local IRB) usually reviews the protocol separately. This can take a long time, cause duplicate work, and even result in the protocol being changed by individual sites so that it is no longer the same across all sites.

One solution is for all sites in a multicenter trial to use the same IRB (a single IRB of record). Although single IRB review is supported by the FDA, the Office of Human Research Protections (OHRP), and the NIH, the willingness of institutions to defer full local IRB review and approval to a single IRB in multicenter trials continued to vary (Sources: FDA & OHRP).

However, as of January 25, 2018, the NIH mandates the use of a single IRB (sIRB) for multisite, nonexempt NIH-funded clinical studies. U.S. institutions engaged in cooperative federally funded research must rely on a sIRB for the portion of the research conducted in the U.S. when the sIRB provision of the revised Common Rule takes effect in January 2020. In addition, the FDA is revising its human subjects protection regulations and guidance because the 21st Century Cures Act required harmonization of human subjects protection regulations between the FDA and the rest of the federal government and modified the Federal Food, Drug, and Cosmetic Act to remove the requirement for review by local institutional review committees for device studies.

Since 2010, CTTI has worked to address challenges of adopting sIRB review. In 2018, this work evolved to focus on supporting adoption of sIRB models.

  1. The Central IRB Project: “Use of Central IRBs for Multi-center Clinical Trials” (2010-2013)
  2. Central IRB Advancement: “Advancing the Use of Central IRBs for Multi-center Clinical Trials” (2013–2015)
  3. Single IRB Evaluation (2018 - ongoing)
  4. Single IRB Adoption (2018 - ongoing)
  • To identify and address barriers to using a sIRB of record for multicenter clinical trials
  • To propose solutions, recommendations, and tools to advance the use of sIRBs for multicenter clinical trials
  • Using a sIRB for a multicenter trial will improve trial efficiency and consistency.
  • Use of the Considerations Document will help delineate the legal and ethical responsibilities of institutions and IRBs in overseeing the conduct of clinical trials and can support communication between institutions and sIRBs.
  • Use of the CTTI-developed tools (including the Considerations Document, an Evaluation Checklist, and a Template IRB Authorization Agreement) will make it easier for sponsors, IRBs, and institutions to implement the sIRB model for multisite research.
  • With widespread use of the sIRB model for multisite trials, study start-up will be accelerated and trial conduct will be improved, allowing treatments to reach patients faster.
  • Literature review
  • Stakeholder interviews
  • Analysis of IRB Authorization Agreements and SOPs
  • Case examples
  • Expert meetings and workshops

As part of driving adoption activities, CTTI continues to engage stakeholders and investigate ways to ease the transition to sIRBs. In November 2017, CTTI convened an expert meeting to discuss further actions that CTTI, the FDA, the OHRP, and the NIH can take to help the research community adopt sIRB review. In 2018, the NIH selected CTTI to support a workgroup that will develop a comprehensive plan for assessing the effectiveness of the NIH’s new sIRB policy. In September 2019, a CTTI driving adoption committee developed a set of new resources, including an Engagement Overview, Engagement Flowchart, Engagement Scenarios Guide, Engagement Definitions, and a Resource of Resources library.

Project Team Members

Role Name Affiliationsort descending Project
Team Member Michele Russell-Einhorn Advarra Single IRB Driving Adoption
Team Member James Riddle Advarra Consulting Single IRB Driving Adoption
Team Leader Soo Bang Celgene Single IRB Advancement
Team Leader Felix Gyi Chesapeake IRB Single IRB
Team Member Margaret Rankovic CITI Program, a Division of BRANY Single IRB Driving Adoption
Team Member Judith Kramer Clinical Trials Transformation Initiative Single IRB
Project Manager Sara Calvert Clinical Trials Transformation Initiative Single IRB & Central IRB Advancement
Social Science Lead Amy Cornelli Clinical Trials Transformation Initiative Single IRB Driving Adoption
Team Member Michael Link Department of Veterans Affairs Single IRB Driving Adoption
Team Leader Kathryn Flynn Duke University Single IRB
Team Member Devon Check Duke University Single IRB
Team Member Carrie Dombeck Duke University Single IRB
Team Leader Jennifer Li Duke University Single IRB
Team Leader Kevin Weinfurt Duke University Single IRB
Team Member Lawrence Muhlbaier Duke University Single IRB
Team Leader Cynthia Hahn Feinstein Institute for Medical Research Single IRB Advancement
Team Member Cynthia Hahn Feinstein Institute for Medical Research Single IRB
Team Member Hallie Kassan Feinstein Institute for Medical Research Single IRB Advancement/Driving Adoption
Team Member Cheryl Grandinetti Food and Drug Administration Single IRB
Team Member Patrick McNeilly Food and Drug Administration Single IRB Advancement
Team Member Patrick Archdeacon Food and Drug Administration Single IRB
Team Member Andy Womack Genentech - a member of the Roche Group Single IRB Advancement
Team Member Jane Perlmutter Individual Patient/Caregiver Single IRB & Central IRB Advancement
Team Leader Petra Kaufmann National Institutes of Health Single IRB Advancement
Team Member John Buse NC TraCS, University of North Carolina at Chapel Hill Single IRB Advancement
EC Champion Pat Furlong Parent Project Muscular Dystrophy Single IRB Driving Adoption
Team Leader Colleen Gorman Pfizer Inc Single IRB
Team Member Cami Gearhart Quorum Review Inc Single IRB Advancement
Team Member Jennifer Peterson Syneos Health Single IRB Driving Adoption
Team Member Deneill Harney University of Michigan Single IRB Driving Adoption
Team Member Robert Silbergleit University of Michigan Single IRB Driving Adoption
Team Member Nichelle Cobb University of Wisconsin Single IRB Driving Adoption
Team Member Carol Pech University of Wisconsin Single IRB Driving Adoption
Team Member Yvonne Higgins WIRB-Copernicus Group Single IRB Advancement