Clinical studies must be reviewed and approved by an IRB before they can begin, and according to NIH, as the research landscape has evolved and more studies are carried out at multiple sites, the use of multiple IRBs has also increased. Working through IRB review at each site can delay studies without increasing the protections for the research participants, the NIH says.
The new draft NIH policy - which was issued last night - proposes that all NIH-funded, multi-site studies carried out in the US, whether supported through grants, contracts, or the NIH intramural program, should use a single IRB. Exceptions to the policy would be allowed if local IRB review is necessary to meet the needs of specific populations or where it is required by federal, state or tribal laws or regulations.
Francis Collins, director of the NIH, said in a statement: “By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”
A number of NIH institutes and centers have been supporting the use of a single IRB in multi-site studies, including the National Cancer Institute’s (NCI) Central Institutional Review Board, which has been in place since 1999, and the National Institute of Neurological Disorders and Stroke’s Network for Excellence in Neuroscience Clinical Trials’ (NeuroNEXT) and its stroke research network, NIH StrokeNET.
CROs seem largely in favour of the use of one IRB for multi-site trials, contending that it could accelerate their start-up and add new efficiencies.
John Lewis, SVP at ACRO (Association of Clinical Research Organizations) told Outsourcing-Pharma.com: “ACRO has long advocated for a single, or central, IRB for multisite trials to accelerate study start-up and bring greater efficiency to the clinical trial process without compromising patient protections. There has been much discussion during various 21st Century Cures hearings and roundtables on the need for centralized IRBs and ACRO has been working with Energy & Commerce Committee staff on legislative proposals to encourage the use of central IRBs.
“While the vast majority of studies involving ACRO members fall under FDA, rather than NIH, guidelines, we are encouraged and very supportive of the NIH draft policy. For trials that take place in multiple countries, in most cases there would still be a need for local IRB or Ethics Committee review in individual countries to comport with regulatory requirements,” Lewis said.
Quintiles, the world’s largest CRO, took a similar, though more tempered view of the draft.
"Quintiles’ experience, derived from conducting numerous clinical studies globally, is consistent with the observations of others involved with clinical research: there is significant variability in the time that it takes for IRBs to review protocols,” Jeffrey Spaeder, SVP and Chief Medical and Scientific Officer, told Outsourcing-Pharma.com. “Some IRBs are very responsive without sacrificing their fiduciary responsibility to provide independent and rigorous oversight of clinical research, however there are other IRBs that introduce administrative delays in the review of protocols. These delays have had an increasing impact on clinical research timelines as the number of sites required for clinical studies increases, while simultaneously studies are becoming more complex, and there are fewer sites that are capable of conducting these more sophisticated studies.”
But reducing the redundancy of IRBs may not be the only way to cut review times for clinical trials
Spaeder continued: “Requiring a single IRB in multi-site trials is one way to reduce heterogeneity of the IRB review timelines, but the goal should not be limited to reducing the redundancy of IRB reviews, but rather accelerating the review of protocols while simultaneously maintaining or enhancing vigorous medical-ethical oversight of the study.”
NIH is seeking public comments on the draft policy through a 60 day comment period closing Jan. 29, 2015. Comments may be submitted via email to FvatyrVEOcbyvpl@znvy.avu.tbi.