Abstract Body: Introduction: Informed consent is a cornerstone of modern clinical research, though ensuring consent has long been recognized as problematic. This is especially true for acute stroke trials, where the time-sensitive nature of treatment challenges traditional consent practices. The era of platform adaptive trials will likely add further complexity to acute stroke consent. Therefore, we sought to survey the literature for any empirical studies documenting research participants’ preferences around what content is most important to include in consent forms.
Methods: We conducted a systematic review of the literature to identify empirical studies reporting patients’ opinions about what content is most important to include in consent forms for research participation. Eligible studies included surveys, focus groups, or interviews. Based on a review of consent form templates, we identified 18 elements that commonly appear in consent forms, and used these to guide our extraction of potential content.
Results: Of the 1,444 studies screened by title and abstract, 35 were sent to full text review, and data were extracted from 17 studies. To determine the ubiquity of the importance of these topics, we counted if each of these topics appeared in the 17 papers. The most commonly mentioned items included risks (65%, 11/17 studies), potential benefits (53%, 9/17 studies), study procedures e.g. blood draws and imaging (47%, 8/17 studies), confidentiality (47%, 8/17 studies), study rationale (41%, 7/17 studies), and voluntariness (41%, 7/17 studies). The least important elements included information about the condition and investigator conflicts of interest.
Conclusion: In the era of adaptive platform trials for acute stroke, there is the potential for consent forms to become incredibly lengthy and complex. This is the first systematic review of which we are aware that seeks to identify what information is most important to be included in consent forms to participate in research studies. Unfortunately, data are limited but they suggest that consent form optimization is possible. Only risks and potential benefits were identified as important in a majority of studies.