Evidence from the literature review suggests that IRB-, sponsor-, and site-related operational barriers exist, along with an inadequate understanding of what patients want from the IC process. No single proven tool for measuring the quality of IC or effectiveness of consent interventions was cited in the literature. Limited, available evidence suggests that the current consent process has direct consequences on the ability to conduct clinical trials. The analysis of the literature review was published in May 2016. The published results from the expert interviews supported these literature review findings and expanded on identified barriers.
All interviewees agreed that IC is essential to the protection of research participants; however, most acknowledged that the IC process in the United States has evolved into a rigid and cumbersome process that requires immediate attention and reform. Interviewees expressed consensus on three major themes: a new approach to the ICD, enhancing participant understanding of the clinical research, and modification of IRB review.
Some barriers that result in lengthy, variable, and overly complicated ICDs include the following:
IRB-related:
- Lack of accepted readability standards
- Local IRB review of ICDs in multisite trials
- Varying interpretations of regulations
- Inadequate training in plain language practices for IRB staff
Sponsor-related:
- Challenging legal language added to ICDs to reduce liability
Staff-related barriers to a successful IC process tend to more commonly result in participant dissatisfaction due to unmet emotional needs or lack of relevant trial information. These barriers include:
- Disconnection between expectations and reality of IC discussions
- Staff de-emphasizes importance of the information to the participant
- Pressure to meet enrollment targets shifts focus away from participants and leads to rushed interactions
To address these barriers, experts explored new approaches to the IC process that focused on enhancing trial participant understanding. The most frequent recommendation for a single actionable change was to reform the ICD required for federally regulated research by making it simpler, shorter, and more understandable. Following this, interviewees proposed multiple strategies to create a more interactive and ongoing IC process to enhance research participant understanding. Some strategies include improving staff training on the conduct of an IC discussion, allowing adequate time and selecting the appropriate setting for the discussion, and providing an opportunity for prospective research participants to speak with other participants as a resource for information. Evaluating participants’ understanding was another topic that experts discussed during the interview. Several interviewees proposed that research participants’ comprehension about the clinical investigation be evaluated. A third consensus issue from the interviews was the need for modification of practices in IRB review of clinical research. Aligned with recommendations from the CTTI Single IRB projects, the most substantive expert recommendation was implementation of a single IRB of record for multisite clinical trials.