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.
Recently, in light of recent mandated changes to the use of sIRBs in multicenter clinical trials, CTTI developed additional resources for determining institutional engagement and collaborated with an NIH workgroup to develop a comprehensive plan for assessing the NIH's sIRB policy. The final evaluation framework report describes suggested next steps and key elements to be included in a future evaluation of the sIRB model.
CTTI also provided an example of a study that successfully implemented the use of a sIRB, IMPACT-AFib, a nationwide pragmatic trial launched by collaborators including CTTI.
Petra Kaufmann M.D., M.Sc. Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS), NIH
“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.”
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.
Cynthia Hahn Chief Operating Officer, Feinstein Institute for Medical Research
“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.”
Soo Bang Senior Director, Business Development and Global Alliances, Celgene Corporation
"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.”
Margaret A. Hamburg, MD former Commissioner, FDA
“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.”
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.
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.
|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||John Buse||NC TraCS, University of North Carolina at Chapel Hill||Single IRB Advancement|
|Team Member||Devon Check||Duke University||Single IRB|
|Team Member||Nichelle Cobb||University of Wisconsin||Single IRB Driving Adoption|
|Team Member||Carrie Dombeck||Duke University||Single IRB|
|Team Member||Cami Gearhart||Quorum Review Inc||Single IRB Advancement|
|Team Member||Cheryl Grandinetti||Food and Drug Administration||Single IRB|
|Team Member||Cynthia Hahn||Feinstein Institute for Medical Research||Single IRB|
|Team Member||Deneill Harney||University of Michigan||Single IRB Driving Adoption|
|Team Member||Yvonne Higgins||WIRB-Copernicus Group||Single IRB Advancement|
|Team Member||Hallie Kassan||Feinstein Institute for Medical Research||Single IRB Advancement/Driving Adoption|
|Team Member||Judith Kramer||Clinical Trials Transformation Initiative||Single IRB|
|Team Member||Michael Link||Department of Veterans Affairs||Single IRB Driving Adoption|
|Team Member||Patrick McNeilly||Food and Drug Administration||Single IRB Advancement|
|Team Member||Lawrence Muhlbaier||Duke University||Single IRB|
|Team Member||Carol Pech||University of Wisconsin||Single IRB Driving Adoption|
|Team Member||Jane Perlmutter||Individual Patient/Caregiver||Single IRB & Central IRB Advancement|
|Team Member||Jennifer Peterson||Syneos Health||Single IRB Driving Adoption|
|Team Member||Margaret Rankovic||CITI Program, a Division of BRANY||Single IRB Driving Adoption|
|Team Member||James Riddle||Advarra Consulting||Single IRB Driving Adoption|
|Team Member||Michele Russell-Einhorn||Advarra||Single IRB Driving Adoption|
|Team Member||Robert Silbergleit||University of Michigan||Single IRB Driving Adoption|
|Team Leader||Soo Bang||Celgene||Single IRB Advancement|
|Team Leader||Kathryn Flynn||Duke University||Single IRB|
|Team Leader||Colleen Gorman||Pfizer Inc||Single IRB|
|Team Leader||Felix Gyi||Chesapeake IRB||Single IRB|
|Team Leader||Cynthia Hahn||Feinstein Institute for Medical Research||Single IRB Advancement|
|Team Leader||Petra Kaufmann||National Institutes of Health||Single IRB Advancement|
|Team Leader||Jennifer Li||Duke University||Single IRB|
|Team Leader||Kevin Weinfurt||Duke University||Single IRB|
|Social Science Lead||Amy Cornelli||Clinical Trials Transformation Initiative||Single IRB Driving Adoption|
|Project Manager||Sara Calvert||Clinical Trials Transformation Initiative||Single IRB & Central IRB Advancement|
|EC Champion||Pat Furlong||Parent Project Muscular Dystrophy||Single IRB Driving Adoption|