Jim Gearhart

by Jim Gearhart

The Varied Meanings of Central IRB

Last year, the National Institutes of Health (NIH), the House of Representatives, and the signatories to the Common Rule all proposed a greater role for central IRBs in overseeing medical research. The NIH wanted to mandate central IRB review for any NIH-funded study with more than one investigator. The House of Representatives endorsed that policy with a call out in its 21st Century Cures Act, and the NPRM (Notice of Proposed Rule Making) for the Common Rule included a similar proposal. As we wait to see how those proposals play out and consider preparing for their implementation, it might be worthwhile recalling the variety of models the phrase central IRB can imply.

 

The Clinical Trials Transformation Initiative (CTTI) defines central IRB as "A single IRB of record for all sites involved in a multi-center protocol."

We can start by noting that central IRB sort of contradicts itself. IRB stands for “institutional review board,” the long-standing term in the US for ethics committees that oversee medical research on people. Institutional reflects that research institutions—primarily hospitals and universities—traditionally handled their ethical reviews in-house with their own committees. One institutional review board per institution. Central, however, means that one committee—affiliated with an institution or not, official abbreviation notwithstanding—can oversee research in multiple locations.

Over the years, the challenge of overseeing many researchers from one location has led to a variety of approaches. Central IRB review now encompasses a number of models for working with multiple research sites. Here is a list of the most common ones:

  • Facilitated Review: A shared responsibility between central and local IRB. The central IRB makes initial decisions, and then a local IRB re-reviews the decisions and possibly amends them.  The National Cancer Institute’s CIRB used a facilitated model until 2012.
  • Reliance Model: IRBChoice reflects this relatively new approach. IRBChoice has established a network of shared information that allows IRBs to pool resources, compare best practices, and sometimes accept each other’s decisions.
  • Lead IRBs: (Also: IRB of Record) A model common to NIH-funded studies. In a multi-site study, the sponsor of the study authorizes one institution’s IRB to oversee research in some or all of the study’s other sites. The other locations can accept that jurisdiction, or opt to review the research themselves. (The NIH and NPRM proposals from last year would make opting out more difficult.) The NIH study NeuroNEXT utilized a lead IRB.
  • Consortium/Regional: A group of research sites share IRB oversight from some unifying element such as affiliation or location. Some university networks have IRBs, as do some research centers that are in the same area. The BRANY group is an example of a consortium.
  • Independent IRBs: While independent also contradicts the institutional of IRB, this phrase represents free-standing review committees which have no direct or permanent affiliation to a research organization. Independent IRBs can have review authority over one, some, or all of the sites in one protocol. Independent IRBs can be privately owned, such as Quorum, and these are often called commercial IRBs. Some independent IRBs are funded publicly. In 2012, the National Cancer Institute’s central IRB, (CIRB), changed from a facilitated model to an independent IRB model.

In the end, central IRB review can mean a number of things. If the NIH and NPRM proposals do come to pass (last year’s public comments on the NIH proposal nicely collected the arguments for and against the idea), we will have some choices about how to meet those new requirements.

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Resources:

Alternative Models of IRB Review Workshop Summary Report. Washington, DC: Department of Health and Human Services; 2005. http://www.hhs.gov/ohrp/archive/sachrp/documents/AltModIRB.pdf  Accessed 1/29/16

“Are Central Institutional Review Boards the Solution? The National Heart, Lung, and Blood Institute Working Group’s Report on Optimizing the IRB Process”, Academic Medicine, Vol. 87, No. 12, December 2012.

Executive Summary of National Heart, Lung, and Blood Institute.  Facilitating NHLBI clinical trials through optimization of the IRB process: Are central IRBs the solution?  http://www.nhlbi.nih.gov/meetings/workshops/irb.htm. Accessed online 2/8/16.

Grady C. “Do IRBs protect human research participants?” The Journal of the American Medical Association. 2010; 304:1122–1123

Institute of Medicine, Washington, DC. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. National Academies Press; 2009.

National Cancer Institute. “Synopsis of the CIRB Independent Model,” December 12, 2012. https://ncicirb.org/cirb/documents/Synopsis%20of%20the%20CIRB%20Independent%20Model.pdf  Accessed online 2/8/16

Report: Department of Health and Human Services National Conference on Alternative IRB Models: Optimizing Human Subject Protection. Washington, DC: Association of American Medical Colleges; 2006. https://www.aamc.org/download/75240/data/irbconf06rpt.pdf  Accessed online 2/8/16

Riddle, James. “Centralized IRB Models” presented at NWABR/OHRP Conference, July 21, 2014. https://www.nwabr.org/sites/default/files/pagefiles/Centralized%20IRB%20Models-James%20Riddle,%20MCSE,%20CIP,%20CPIA.pdf Accessed online 4/20/2016

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