“Requiring the use of a single IRB for multi-site trials will bring added efficiency to the clinical trial process, greatly benefiting patients and researchers. The NIH should be commended for holding its ground from the proposed policy,” John J. Lewis, Senior Vice President, Policy & Public Affairs, at the Association of Clinical Research Organizations (ACRO) told us. “The current arcane system is not sustainable and does not serve to provide any additional protections to research participants.”
The final policy document, which was published today, states: “All sites participating in a multi-site study are expected to rely on an sIRB [single institution review board] to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46.”
According to the NIH document, the policy seeks to eliminate duplicative IRB review in order to reduce “unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections.”
The policy is expected to allow IRBs to focus on reviewing single site protocols, as opposed to conducing redundant reviews, which will result in enhanced research oversight, according to NIH.
Catching up to the private sector
David Borasky, MPH, CIP, VP of quality management at Copernicus Group IRB, a WIRB-Copernicus Group company told us the policy is important because past efforts to encourage the use of a single IRB for multi-site research have not been effective.
“NIH research is typically conducted at academic institutions, which have a long history of having internal IRBs that are expected to review all research involving human subjects, and these institutions have been reluctant to rely on another IRB,” added Borasky.
However, the new policy is consistent with the majority of industry-sponsored multi-site clinical trials, “which have consistently used single IRBs for multi-site studies for many years,” said Borasky. Additionally, it is also in line with NCI’s policy requiring central IRB review of most Cooperative Group oncology studies.
According to Borasky, the NIH realized that allowing each institution’s IRB to review multi-site research studies was inefficient and costly, and didn’t enhance human subject protections. “On the contrary, it slows down research and makes it inconsistent across sites,” he said, commenting that “the NIH is catching up to the private sector.”
Additionally, regulatory authorities (OHRP, FDA) have consistently indicated that the use of single IRBs was permitted by the regulations and they have consistently supported the use of single IRBs – as well as sponsors and CROs.
“Sponsors and CROs realized many years ago that the use of a single IRB was faster, more efficient, and more economical than having IRBs review studies at every site, and none of these efficiencies had a negative impact on the quality of review and human research subject protections,” said Borasky.
“CROs and sponsors have tolerated re-review of research by local IRBs when they require the participation of particular investigators at institutions with policies eschewing central IRB review,” he added.
According to Borasky, the expectation of the new NIH policy has already begun influencing institutions that had traditionally been resistant to using anything but their own local IRB to get comfortable with the idea. Copernicus Group IRB, as well as sponsors and CROs, are already seeing an increasing number of institutions that had been local IRB sites, now using central IRBs – and Borasky expects to see this trend continue.
The policy is set to take effect May 25, 2017.
However, since companies in the private sector have already implemented the use of single IRBs for years, policy doesn’t bring much change to industry-sponsored research. “The policy only applies to NIH-funded multi-site research, so the majority of industry-sponsored research is not subject to the requirements of the policy,” explained Borasky. “Nevertheless, NIH’s mandate may well nudge sponsors to required central review, and industry’s tolerance for local IRB review will diminish.”
Institutions voice concern
A proposed draft policy was published on December 3, 2014, for public feedback, after which NIH received a total of 167 comments from a range of stakeholders, including individual researchers, academic institutions, IRBs, patient advocacy groups, scientific societies, healthcare organizations, and the general public.
The majority of other commentators were supportive of the new policy; however, others did voice concern – mainly, academic institutions and the organizations representing them disagreed with the policy’s scope, commenting that it should become a term and condition of funding, further suggesting the NIH create incentives for reliance on an sIRB, but not requirements.
Borasky told us that there are several reasons for this; first, many institutions prefer to keep IRB review in-house and have limited experience with central review. “They also incorrectly perceive that local review allows them to better track the research locally,” he explained.
Additionally, significant financial and human resources are required to serve in the role of single IRB and according to Borasky “all but the few institutions that have received millions of dollars in special IRB support are ill-prepared to function as an effective and efficient central IRB.”
“The people, processes, and technology supporting local IRBs were set up to accommodate single-site review only,” he added.
Some institutions have also expressed concern that the policy could lead to the loss of indirect charges that institutions receive to support functions, such as IRB. However, Boraksy said that for most large institutions, “this is a vestige of outdated indirect cost-basis negotiations with NIH.”
“Today, large research institutions are already receiving the maximum indirect cost reimbursement rate, without factoring in the IRB,” he added.
Others opposed have suggested that they have a unique understanding the study subjects, institutional issues, and local law that would be discounted by single IRBs. “Of course, central review has managed these issues effectively for decades,” said Borasky.