Neurological Multicenter Clinical Research in Vulnerable Populations: Variability in Institutional Review Boards' Responses
Aims: Children and patients with cognitive deficits may find it difficult to understand the implication of research. The aim of this study is to evaluate the process of institutional review boards (IRB's) for the review of two different neurological multicenter research protocols involving vulnerable subjects (children and adult stroke patients).
Methods: The methods include descriptive and comparative statistics.
Protocol 1 is a prospective, multicenter, cross-sectional screening study of a symptomatic pediatric population at risk for Fabry disease involving genetic testing (NCT02152189).
Protocol 2 is a prospective, multicenter, randomized, controlled, open-label, blinded end point postmarket study to evaluate the effectiveness of stent retrievers (NCT02135926). After having obtained positive initial IRB votes at the main study site, both protocols were subsequently submitted to the remaining IRBs.
Results: Protocol 1 was submitted to 19 IRBs. Overall, 16 decisions were made. No IRB objected to the study. Median time-to-final vote was 29.5 (IQR, 9–54; range, 0–120) days. Two IRBs accepted the coordinating center's vote without reevaluation. Changes to the informed consent documents were asked by 6 of 16 IRBs, amendments to the protocol by two IRBs.
Protocol 2 was submitted to 16 IRBs. Overall, 14 decisions were made. No IRB objected to the study. Median time-to-final vote was 58 (IQR, 9–103; range, 0–128) days, which was not statistically significantly different compared with protocol 1 (Wilcoxon test). Two IRBs accepted a previous IRB decision and did not conduct an independent review. Of 14 IRBs, 4 required changes to the informed consent documents; 2 IRBs recommended an amendment of the protocol.
Conclusion: Both the clinical research protocols involving vulnerable populations were well accepted. IRB workflows and decision times varied substantially. Some IRBs accepted a previous IRB decision without the necessity of another reevaluation process. Most required changes involved the informed consent documents. Knowledge of IRB workflows and decision times is helpful for site selection strategies.
Keywords: clinical research, ethics, institutional review boards, orphan diseases, Fabry disease, stroke.