Clinical

When an investigator has the option to use a central or a local IRB/IEC, under what circumstances is it advantageous to use the central instead of the local IRB?

Central vs. Local

When an investigator has the option to use a central or a local IRB/IEC, under what circumstances is it advantageous to use the central instead of the local IRB? What might be the risks of using the central IRB/IEC, even when it is advantageous over the local IRB/IEC?

If each institution involved in a multicenter clinical trial were to submit research protocols along with other documents to its own IRBs, this would lead to major delays in the initiation of the study activities at all sites. During a multicenter trials, institutions perform multiples studies at the same time, meaning the usage of both institutional IRB and a central IRB will not only increase unnecessary expenditures, but it will also delay clinical trial conduct causing each institution to stagger out in process [2,3]. Thus for a multicenter clinical trial, utilizing the central IRB would save time and money, reduce unnecessary workload of institutional lRBs, and reduce delays in initiation.

Furthermore, the Central IRB can provide universal guidance / join reviews to institutions that carry out similar field trials. In fact, the central IRB of the National Cancer Institute “reviews all NCI – sponsored adult oncology Phase III multicenter trials” [1]. If the central IRB oversight is efficient, it will be able to speed up the process by detecting safety problems quickly and easily, which not only aids in advancing the trial itself, but for all future pipeline studies for similar investigations.

However, Central IRBs do pose some risks even in situations where it seems like it is advantageous over the local IRB / IEC.

Oftentimes, a Central IRB is located within an institution that is involved in the multi-institutional clinical trial, and provides oversight across study sites that are located elsewhere. This makes it difficult for the Central IRB to be fully knowledgeable about the onsite details of the various institutions involved. Considering that the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research suggested that IRB members should include “men and women of diverse backgrounds with sufficient maturity, experience, and competence, so that the IRB will be able to do its responsibilities, and its determinations will be accorded respect by investigators and the community served by the institution or in which it is located,” this may pose a serious issue in study diversity and thus validity [4]. Furthermore, in the case of a joint review, not all individuals will be aware of the details of a local IRB’s agreement with the central IRB. Thus confusion and miscommunication can occur compared to if the staff were to communicate with a local IRB.

In conclusion, the key responsibility of an IRB is to protect the rights, safety, and well being of human subjects. This goal is achievable by using either central or local IRBs, so it is important that institution carefully weigh their options when making a decision on which IRB to utilize in their studies.

Sources

[1] National Cancer Institute. 2016. Central Institutional Review Board—Standard Operating Procedures. https://www.ncicirb.org/sites/ncicirb/files/CIRB%20SOPs%20051716_v2.pdf

[2] Silverman H, Hull SC, Sugarman J. 2001. Variability among institutional review boards’ decisions within the context of a multicenter trial. Crit Care Med 29(2):235–41. https://www.ncbi.nlm.nih.gov/pubmed/?term=Variability+among+institutional+review+boards%27+decisions+within+the+context+of+a+multicenter+trial

[3] McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. 2003. Problematic variation in local institutional review of a multicenter genetic epidemiology study. J Am Med Assoc 290(3):360–1. https://www.ncbi.nlm.nih.gov/pubmed/12865377

[4] Federal Register (Vol. 46, pp. 8958­–70; January 27, 1981). Rice TW. 2008. How to do human-subject research if you do not have an institutional review board. Resp Care 53(10):1362­–7. www.rcjournal.com/contents/10.08/10.08.1362.pdf

Categories: Clinical