Stakeholder Views on Novel Consent Forms for an Acute Stroke Trial

Area of Science:

• Clinical Research Ethics
• Emergency Medicine
• Health Services Research

Background:

• Lengthy consent forms pose challenges for emergency clinical trials.
• Innovations in consent processes are difficult to implement in time-sensitive research.
• A context-sensitive consent form and information sheet were developed and approved by a single institutional review board (sIRB).

Purpose of the Study:

• To assess the views of research teams and local institutional review board (IRB) / human research protection program (HRPP) representatives on using a novel, abbreviated consent form and information sheet in a multisite stroke trial.
• To evaluate the implementability and perceived benefits of the streamlined consent process.

Main Methods:

• Semistructured interviews were conducted with 22 local IRB/HRPP respondents and study team members across various study sites.
• Qualitative data were collected on the usability, clarity, and impact of the consent materials and process.

Main Results:

• Study teams found the abbreviated consent form patient-centered and implementable, appreciating the separation of core information from supplementary details.
• IRB/HRPP respondents valued the simplified language and formatting, supporting the innovative approach.
• Respondents expressed uncertainty regarding local IRB approval and optimal use of the information sheet, highlighting the need for further experience.

Conclusions:

• The developed consent forms are patient-centered and implementable, positively impacting study team interactions and processes.
• Single IRB (sIRB) review processes show potential for facilitating innovative consent approaches in emergency research.
• Further experience is required to optimize the integration of supplemental written information within emergency research consent procedures.