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The National Institutes of Health (NIH) is issuing this policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.
Comments from researchers that supported the draft policy described unnecessary delays and additional costs caused by duplicative IRB reviews. They noted that IRB submission requirements at each site differ and take time to navigate and manage. They also indicated that review of the same protocol by multiple IRBs can sometimes lead to protocol and consent document changes that can introduce inconsistencies in the execution of the protocol across sites, lead to enrollment imbalances, and skew the analysis of the aggregated data. More often, however, multiple IRB reviews result in changes to consent documents that are merely stylistic and not substantive, or changes that focus on institutional interests (e.g., liability management) rather than human research protections. Commenters raised the concern that the current practice of requiring multiple IRB reviews may actually contribute to some researchers reluctance to participate in rigorous, multi-site research and may incentivize smaller and simpler study designs.
Scientific and professional societies generally favored the proposed policy. These stakeholders stated that the policy would decrease administrative burdens on clinical research staff, speed up participant recruitment, and streamline the research process and that these changes would result in enhancements to the efficiency of research and acceleration of research progress. They also suggested that the benefits of such a policy include enhanced adverse event monitoring and improvements to the quality and consistency of IRB reviews.
Most of the comments from patient advocacy groups and participant representatives were supportive of the proposed policy. These stakeholders pointed out that greater use of single IRBs will lead to enhanced protections through increased accountability and improved efficiency.
Applicability
Most commenters supported a broad application of the policy to all studies involving the same protocol carried out at multiple sites in the U.S. These stakeholders stated that use of a single IRB of record for all types of studies and populations and study arrangements would encourage standardization of clinical research protocols and more effective implementation of protocols and protocol amendments. In contrast, a number of commenters suggested that the NIH should narrow the application of the policy or phase it in over time. Ideas about how the applicability of the policy should be narrowed were wide-ranging. Some stakeholders suggested that the level of risk should be a consideration in whether the policy should apply, with some pointing to minimal risk research and others to research involving more than minimal risk as being more appropriate for single IRB review. Others suggested that the policy should apply only to multi-site studies that involve a large number of sites (e.g., greater than 10); only to research involving clinical trials; only to studies carried out within established cooperative groups; or only to lengthy studies requiring an extended period of IRB oversight, e.g., three years or more. Some commenters suggested that the applicability of the policy remain broad, but that it be phased in over time.
Need for Implementation Guidance
Ā A number of commenters pointed out how important it would be for the NIH to provide practical guidance to facilitate the implementation of the policy, with some commenters stating that, in the absence of such guidance, burden and costs would only shift between institutions rather than adding efficiency to the IRB process. A few commenters noted that this guidance could be developed using the experiences of IRBs that have already implemented centralized IRB review processes.
The NIH recognizes that the policy will begin a paradigm shift in IRB review. As such, the final policy will not take effect until May 25, 2017. In the interim, the NIH will issue guidance and provide resources to assist awardees in adapting to the shift.
Finally, while the NIH anticipates that that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of sIRBs will outweigh any costs and, ultimately, reduce burdens to the research process. At the same time, the NIH will also closely monitor the implementation of the policy, consider its impact on research such as improvements in time to initiation of research and reduction of unnecessary burden, and be vigilant about any diminution in the protection of human subjects.Ā
National Institutes of Health Policy on the Use of a Single Institutional Review Board for Multi-Site Research
PurposeĀ
The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board of Record for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46. This policy, which is consistent with 45 CFR Part 46.114, is intended to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human research participants.
Scope and Applicability
This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.
Awardees. Awardees are responsible for ensuring that authorization agreements are in place; copies of authorization agreements and other necessary documentation should be maintained in order to document compliance with this policy, as needed. As appropriate, awardees are responsible for ensuring that a mechanism for communication between the sIRB and participating sites is established. Awardees may delegate the tasks associated with these responsibilities. e24fc04721
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