By Rory McCann

July 18, 2016 | The National Institutes of Health (NIH) has issued a new policy stating that all NIH-sponsored multi-site research protocols within U.S. jurisdiction must use a single Institutional Review Board  across all sites. An Institutional Review Board is a committee set up to protect the rights of human research subjects by assessing protocol guidelines of a clinical study. NIH hopes to simplify the review process by cutting out additional administrative steps and promote greater efficiency. IRBs are meant to protect all human, however, multiple IRBs can hinder the process by duplicating efforts, multiplying costs, and causing delays with redundancy. The new single IRB policy is designed to streamline protocol review, while still promoting discovery and protecting the rights of all human subjects.

The NIH published a draft of the policy on December 3, 2014, and invited readers to submit comments and suggestions. The proposal received more than one hundred comments before the final version was published on June 21, 2016. Academic and research organizations, as well as individuals, submitted their thoughts on the draft. Most were overwhelmingly supportive, if not for the specific policy changes, then for the push for overall reform, many writing that it was a necessary change. Some simply stated their support for the effort, while others elaborated on the benefits of such a change. One commenter stated:

“I think this is a great idea to help speed up the pace of research discoveries by eliminating duplication of bureaucratic processes at multiple institutions. The IRB review process is extremely important, but it does not need to be repeated at multiple institutions for the same study. Using a single IRB of record for review purposes would be much more efficient, both in terms of time and resources.” (Paula C. Hull, Ph.D.) 

Meanwhile, others feared that the IRBs would be less effective if regulated too stringently. For example, IRBs connected with institutions maintain a relationship, and may be more productive with a knowledge of local laws and practices. While the NIH believes the use of single IRBs would be more cost effective, some commenters expressed doubts about the overall benefits of the approach:

“The Draft Policy asserts that local IRB review is not needed for assessing local context. While we agree this is not an IRB regulatory requirement, we note that it is generally the local IRB or at least the local IRB office that is most knowledgeable about the local context and about the application of local rules and norms to the conduct of research. Therefore recognition of the practical reality of ongoing IRB office, if not IRB, involvement is necessary.” (Paul J. Anderson, M.D., Ph.D., Brigham & Women’s Hospital) 

Those who supported the policy change still had doubts regarding its implementation. Pfizer’s Dr. Roslyn F. Schneider, in her email response to the NIH, pointed out that, although the big-picture goal of the policy seemed productive, additional language would be necessary. Specifically, she stated that the transition would not be a smooth one for some IRBs that lack the proper processes to function as the sole IRB for a study, and that the NIH should incentivize the new policy and provide a timeline for adherence.

“Many IRB systems differ in terms of standards and do not have the systems or processes to function as a centralized IRB,” Schneider wrote. “Therefore, we would recommend that the NIH clarify the timeframe for adoption and include appropriate incentives to promote the use of single-IRB for multi-site research. This would help to encourage and provide institutions with necessary time to standardize and adopt centralized review processes.”

Compliance capability was a common concern that came up during the draft process, and the NIH addressed it with an exceptions clause in the final version stating, “Requests for exceptions that are not based on a legal, regulatory, or policy requirement will be considered if there is a compelling justification for the exception.”

The policy will not take full effect until May 25, 2017, allowing the NIH to provide time and resources to enable a smooth transition. The policy still remains open for debate and discussion while the NIH reinforces its commitment to a smooth and productive process that promotes safety and wellness for all subjects and future beneficiaries of these trials.