Stakeholder Views on Novel Consent Forms for an Acute Stroke Trial

Abstract

Lengthy consent forms are poorly suited for clinical trials in emergency contexts; however, innovations in consent processes are challenging to implement. A previously developed, context-sensitive consent form and information sheet were approved by a single institutional review board (sIRB) of record for use in a multisite stroke treatment clinical trial. This study sought views on using these materials by research teams and representatives from local institutional review boards (IRBs) and human research protection programs (HRPPs). Semistructured interviews were conducted with 22 local IRB/HRPP respondents and study team members from various study sites. Study teams appreciated the abbreviated length of the consent form and how the information tailored to help patients' decisions was included while supplementary information was placed in an information sheet. They also described positive impacts on their interactions and processes; IRB/HRPP respondents valued the simplicity of the language, formatting, and attention to what was in the consent form versus what was on the information sheet. They supported the efforts and questioned whether local IRBs would have given approval. Some respondents were unsure of how to best use the information sheet. The consent forms were found to be patient-centered and implementable by study teams. Further experience is needed to identify optimal ways of incorporating supplemental written information. Since many of the IRB/HRPP respondents were uncertain whether their local IRBs would have approved the consent materials that were approved by the sIRB, these findings reinforce the potential for sIRB processes to facilitate the implementation of innovative approaches to consent.

Keywords: clinical trial; consent form; human subjects research; informed consent; institutional review board (IRB); research ethics; stroke.