Central IRBs: Simplifying the Approval Process for Multisite Studies

Clinical trials play a crucial role in the development and evaluation of medical treatments and interventions. Essentially, their objective is to evaluate medical, surgical, or behavioral interventions. Given that clinical research involves human participants, it is imperative to adhere to ethical and regulatory guidelines that prioritize the safety and welfare of participants. Typically, two types of independent boards oversee clinical trials: Institutional Review Board and Central Review Board.

Institutional Review Boards (IRBs) in clinical research

In the realm of clinical research, Institutional Review Boards (IRBs) serve a critical function by conducting rigorous review and monitoring of study protocols. IRBs are also commonly referred to by various names such as the Ethical Review Board (ERB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) in different regions across the globe.

What is the main goal of IRBs?

These entities are tasked with the responsibility of ensuring that clinical trials are conducted ethically, with the protection of study participants as the highest priority. IRBs typically consist of a diverse group of individuals, including researchers, healthcare providers, and community representatives, who review the study's proposed design, methodology, and informed consent procedures to ensure compliance with ethical and regulatory guidelines. Ultimately, the IRB's primary goal is to protect the rights and welfare of human subjects involved in research.

Institutions involved in research, like hospitals and universities, can also hire and pay independent review boards for research review services. Such independent review boards are called commercial IRBs. A popular example of a commercial IRB is WIRB IRB, short for Western Institutional Review Board.

Centralized IRBs (CIRBs) on the rise worldwide

Clinical investigations that fall under the IND regulations require approval from an IRB as per 21 CFR part 56. These requirements were created at a time when clinical trials were more simple and limited to a single or a few study centers.

However, the number, complexity, and size of clinical trials have grown with time, causing an extra burden on local IRBs. For a multicenter study, the IRB at each study center had to review research protocols and informed consent. Multiple reviews of the same research proposal mean unnecessary duplication of effort, delays, confusion, and increased expenses in the process. This is why the centralization of IRBs is gaining popularity worldwide. [¹]

Central IRB definition

Central IRB refers to an institutional review board that performs reviews on behalf of all sites participating in a multicenter study.

A Central IRB establishes an agreement with the IRBs of all individual institutions participating in the centralized review process. The agreement divides the responsibilities between the central IRB and local IRBs.

Central IRBs handle all required IRB documentation and communication, like tracking approvals, communicating with local IRBs, maintaining regulatory documents, and managing adverse event reporting.

The U.S. federal government uses the term ‘single IRB’ in its revised Common Rule for research involving humans, necessitating the use of a single IRB for federally funded, collaborative, multi-site studies. [²]

Central IRB vs. local IRB

Both central and local IRBs oversee research protocols to safeguard the rights and welfare of participants. The key difference between a central and local IRB is that a local IRB is part of an institution that conducts and reviews single-center studies. In contrast, a central IRB handles reviews for multiple centers involved in a study.

Other differences include the level of oversight and review. Central IRBs provide a more standardized and efficient review process across multiple institutions involved, while local IRBs are better suited for providing a tailored and specific context review.

Moreover, central and local IRBs may also differ in terms of the standards they set for research approval and their independence from the government. Central IRBs are better suited for large, multicenter studies, while local IRBs are more appropriate for studies conducted within a single institution or community. Plus, a local IRB is more suitable for short-term projects that don’t require extensive federal oversight.

Benefits of using a central IRB for a multicenter study

Authorities like The Food and Drug Administration (FDA), the Department of Health and Human Services (DHHS), and the Office of Human Research Protections (OHRP) favor the use of a central institutional review board (IRB) to conduct multicenter clinical trials in the U.S. more efficiently.

Multicenter trials consume significant time if each institution participating in the trial submits to its local IRB as per the guidelines. This causes a delay in the initiation of study-related tasks. [³]

Since institutions have numerous studies in their pipelines, submitting to both the local and the central IRB for every aspect of a project can result in an unnecessary duplication of efforts.

• Using a central IRB saves time, avoids delays, and reduces the workload on local IRBs.
• Submitting the requirements to a single, centralized board is less costly than submitting to numerous local IRBs.

Conclusively, a centralized review allows clinical trials to be conducted with consistency, quality, and efficiency.

Criticism and drawbacks of CIRBs

• A joint review may lead to confusion and miscommunication because not all staff members know the agreement between local IRBs and a central IRB.
• Central IBRs may not have the same level of knowledge on the local details of various sites involved. Local IRBs have better knowledge of the community, including factors such as ethnicity, educational level etc. This knowledge helps local IRBs better understand the variance in local community values.

The choice between using a central IRB or multiple local IRBs depends on several factors, like the nature of the study, the number of sites involved, and the requirements of funding agencies or regulatory bodies.

Conclusion

Using a central IRB provides several advantages over relying on multiple local IRBs, like increased efficiency, consistency in review, and reduced administrative burden for study sites.

Some funding agencies or sponsors may also require the use of a single IRB for non-federally funded multi-site studies. Regardless of the type of IRB utilized, the ultimate goal is conducting the research with the highest ethical standards.