The implementation of the single institutional review board (sIRB) model has gained significant traction in recent years, particularly with mandates from federal regulatory agencies such as the National Institutes of Health (NIH) and the Office for Human Research Protections (OHRP). While this shift aims to streamline multi-site research, it has also introduced new complexities for institutions and IRBs.
A Brief History of Single IRB
Historically, IRB systems were decentralized, with each institution conducting its own ethics review for research involving human subjects. This system worked well when research was largely conducted within a single site. However, the rise of multi-site research in the 1990s and early 2000s highlighted inefficiencies in this model, as institutions conducting the same study were subjected to multiple, sometimes conflicting, IRB reviews.
In response, the NIH implemented a policy in 2018 mandating the use of an sIRB of record for all multi-site studies. This model was later incorporated into the revised Common Rule by OHRP in 2018. The goal was to reduce administrative burden, streamline study startup times, and enhance the efficiency of clinical trials without compromising ethical oversight.
How Single IRB Works
The single IRB model designates one IRB as the “IRB of record” responsible for overseeing the study for all participating institutions. This IRB is charged with ensuring compliance with federal regulations, while the other institutions, known as relying institutions, contribute through a local context review. This local review ensures site-specific policies, state laws, and community standards are considered.
The reliance process involves documentation between the IRB of record and the relying institutions, usually through reliance agreements like those provided by the SMART IRB platform. These agreements outline each institution’s responsibilities, reducing the need for negotiating individual agreements for each study. However, institutions must still undergo local reviews for issues such as radiation safety, pharmacy reviews, and other ancillary concerns.
Challenges in Implementation
While the sIRB model offers many potential efficiencies, institutions face several challenges during its implementation. One major challenge is navigating local context reviews. Although these reviews are not full IRB reviews, they still require the submission of materials to ensure site-specific policies and procedures are followed. This additional step can slow down the process, especially in institutions with less robust research infrastructures.
Moreover, establishing reliance agreements between the IRB of record and relying institutions can be time-consuming. Institutions may use agreements like SMART IRB, but not all sites are signed onto these platforms. In such cases, institutions need to draft and negotiate individualized agreements, which can further delay the process.
In addition to reliance agreements, many institutions are still learning how to effectively streamline the local context review process. The onboarding process for sIRB reliance can take longer than study teams expect, leading to frustration and delays in starting clinical trials.
Optimizing the sIRB Process
To make the sIRB model more efficient, institutions need to adopt established, clear reliance processes early. By using platforms like SMART IRB, which offer a master reliance agreement and other resources, institutions can streamline the reliance process and reduce time spent on negotiations. SMART IRB’s single sign-on approach allows institutions to bypass lengthy agreement reviews, as all parties agree to the same terms from the outset.
Institutions can also benefit from creating clear workflows for local context reviews. Using tools like two-part consent forms is key, which separate general study information from site-specific details such as HIPAA language and local contact information. This allows local institutions to review only the sections relevant to them, speeding up the process without compromising compliance or ethical review.
Another key to success is communication. Clear communication between the IRB of record and relying institutions is of utmost importance, particularly when managing expectations around timelines.
Regulatory Developments
The regulatory landscape for sIRB is continuing to evolve. In September 2023, the FDA published a draft rule proposing the expansion of the sIRB mandate to studies regulated by the FDA. Public comments are still being collected, but if the rule is implemented, it will mark a significant step toward harmonizing IRB requirements across federal agencies.
Moreover, OHRP’s recent draft guidance on sIRB addresses questions about local legal considerations, including how IRBs of record should handle state and local laws. Although the guidance is not yet finalized, it provides valuable insight into the role of sIRB in navigating local legal issues. A central resource or database of state laws can benefit institutions, helping them better understand legal requirements potentially impacting their IRB determinations.
While the sIRB model offers a more efficient framework for multi-site research, its implementation requires careful planning, clear communication, and a robust understanding of both local and federal regulations. Institutions investing in streamlined processes and leveraging tools like SMART IRB will be better positioned to overcome the challenges and fully realize the benefits of sIRB.
As federal mandates expand and guidance continues to evolve, institutions must remain flexible, adjusting their processes to ensure compliance while maintaining the highest standards of ethical review. By doing so, they can ensure the shift to single IRB not only reduces administrative burden but also enhances the integrity and efficiency of clinical research.
