Single IRB Concerns Include IT Limitations, Process Variations
If research involves human subjects at multiple sites, a single IRB review process is required under both National Institutes of Health policy and Common Rule guidelines. Previously, each institution used its own IRB to review study protocols, an inefficient and inconsistent process.
Although the switch to a single IRB was challenging for many, new evidence suggests people are becoming more comfortable with the approach.1 Researchers at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership founded by Duke University and the FDA, interviewed 34 stakeholders on their perceptions of using a single IRB for FDA-regulated research.
Participants identified consistency, standardization, speed and efficiency, and simplification as benefits. Challenges include less timeliness of the research review process, insufficient communication, and uncertainty at local institutions. Previous research identified concerns about liability and the time to execute reliance agreements.2 “The time to execute a reliance agreement was a concern for all involved — sponsors, coordinating centers, investigators, and patients,” says Sara Bristol Calvert, PharmD, one of the study’s authors and a senior project manager at CTTI.
These findings suggest those previously reported perceived barriers have been at least somewhat alleviated. “It was reassuring that some items that were concerns for the use of single IRB earlier on were not concerns, or were mentioned infrequently by participants,” Calvert says.
This likely reflects ongoing work by multiple groups to alleviate concerns about single IRBs. Processes and standardized reliance agreements have been developed by the SMART (Streamlined, Multisite, Accelerated Resources for Trials) IRB Reliance platform, the NCI Central Institutional Review Board, and CTTI. Many IRBs still struggle with how to divide responsibilities and establish communication channels between the single IRB and the multiple institutions.
Another persistent concern: How to determine the most relevant aspects of local context, and how that is incorporated into the single IRB review. “Although resources are available to address these challenges, variable processes across single IRBs and institutions still cause confusion and can cause delays,” Calvert acknowledges.
Clear communication among investigators, their institutions, and the single IRB can help mitigate all these problems. Notably, some important responsibilities remain under the purview of the local institution, such as investigator qualifications and radiation safety. “Clear communication of the investigator with those responsible at their institution for these reviews, and whether these reviews can be done in parallel with the single IRB’s ethics review, can be helpful,” Calvert offers.
Standardized processes for asking questions and gathering timely responses (e.g., an online system, hotline, or designated person to communicate) also prevent confusion. These positive changes have created more of a comfort level with the single IRB concept. “The single IRB process has gained efficiency and offers increased standardization,” Calvert reports.
In another study, researchers observed IRB meetings and interviewed staff, chairs, and members from 20 boards to explore the issues that arose when serving as a single IRB.3 IT issues unexpectedly became a central focus. “Part of what we heard ... were the difficulties they faced in managing their IT systems in the context of serving as a single IRB,” says Paul S. Appelbaum, MD, one of the study’s authors and director of the Center for Law, Ethics, and Psychiatry at the Columbia University College of Physicians & Surgeons.
IT-related issues included problems with outside investigators gaining access to submit protocols, lack of interoperability across systems, and legacy systems that were not designed with single IRBs in mind. Based on the findings, IRBs that are anticipating serving as single IRBs for multisite studies “would be well-advised to investigate the extent to which their IT systems are up to the task,” Appelbaum advises. “Institutions looking to be functional in this role may need to purchase new software to allow single IRB functions to be performed efficiently.”
Sufficient time and resources must be allocated for staff training on new or modified systems. “This needs to be done thoughtfully and in advance of serving as a single IRB,” Appelbaum adds.
- Corneli A, Dombeck CB, McKenna K, Calvert SB. Stakeholder experiences with the single IRB review process and recommendations for Food and Drug Administration guidance. Ethics Hum Res 2021;43:26-36.
- Flynn KE, Hahn CL, Kramer JM, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS One 2013;8:e54999.
- Murray A, Pivovarova E, Klitzman R, et al. Reducing the single IRB burden: Streamlining electronic IRB systems. AJOB Empir Bioeth 2021;12:33-40.
Consistency, standardization, speed and efficiency, and simplification are reported benefits. Challenges include timeliness of the research review process, insufficient communication, and uncertainty at local institutions.
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