Background/Purpose: Inclusion of ethnic minority subsets in clinical research remains subpar despite mandates for increased participation. Lack of trust, cultural sensitivity and bias, stereotyping, health literacy are all acknowledged barriers that are active areas of rehabilitation ^{4, 5}. Ethnic minority patients are often cared for by ethnic minority physicians, and despite their limited health coverage, target academic institutions to receive care^{1, 2}.Therefore, academic institutions with ethnic minority clienteles and physicians are the prime targets for recruitment of non-Caucasians in clinical trials. However, whether administrative operations at ethnic minority institutions can facilitate this process, and in timely fashion, is unknown. We examined the time intervals for approval of administrative procedures for clinical research at a predominantly ethnic minority academic institution.  

Objective: To assess time intervals for the administrative approval procedures for clinical research at a predominantly ethnic minority institution.

Methods: At a single historically Black academic institution (HBCU), we examined the time points for multiple clinical trials between submission and responses to institutional review board review, and contract negotiations. The agreed contractual numbers for each study and their unit reimbursement were also obtained. Time to approval of each stage was documented, including the final approval in relation to study initiation.

Results: The average time for IRB approval across 8 clinical trials was 3.75 months, ~ 6 weeks longer than other local academic institutions (1.5-3m). The most frequent reason for delay was multiple, repetitive queries, which could have been avoided by systematic review processes. Additionally, contract approval for 4 funded clinical trials was 8.5 months, resulting in the inability to recruit patients before study closure, with potential loss of institutional funds ($10, 226/patient).

Conclusion: At a single HBCU academic site, there was a consistent, prolonged interval for each step of approval of clinical research. Although it is unknown if enrollment would have met targets, these results suggest a significant lost opportunity for inclusion of ethnic minority subsets in clinical trials. Further, the potential loss of revenue to the institution due to these inefficiencies, cannot be ignored. Measures to improve the process must therefore be an integral requirement of the overall process for increased ethnic minority involvement in clinical research.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/administrative-barriers-to-enrollment-of-ethnic-minorities-in-clinical-research-of-rheumatic-immune-mediated-diseases/