Plain Language Informed Consent Forms and Processes to Promote Empowered Decision Making for People Underrepresented in Research

The complexity of informed consent forms and processes makes it hard for potential study participants to make informed decisions about whether or not to participate in clinical research. Numerous studies document that research informed consent forms are written at reading grade levels that far exceed readers’ abilities (Larson 2015, Hadden 2017). Studies also document participant confusion or misunderstanding related to key study information explained in the consent process (Rothwell 2017, Afolabi 2018). Panelists will present different perspectives on improving informed consent forms and processes from four different research institutions, all with a strong commitment to person-centered informed consent decision-making for people underrepresented in research.

The first panelist will begin with a presentation on what makes research informed consent forms and processes (e.g., e-consent) hard to read, understand and act on from the user experience perspective. This presentation will provide a unique focus on the consent process and using tools to support inclusive and informed partnerships.

Our second panelist will present on the development of the Readability, Understandability and Actionability of Key Information (RUAKI) Indicator, a validated and reliable tool researchers can use to create easy to read informed consent summaries potential participants can understand and use to make informed decisions about participating in research (manuscript in development). This presentation will provide a focused look at how to make key information on informed consent forms easier to read.

Our third panelist will present on best practices and tools to support effective, person-centered consent for racial and ethnic minorities. The panelist will raise linguistic and cultural issues to consider when consenting minority participants and share culturally sensitive consent approaches to support empowered and active decision-making. This presentation will provide a focused look at addressing the needs and concerns of underrepresented groups in research.

Our final panelist will present informed consent process improvement and communication innovations. Consent Builder is an electronic tool that streamlines the process of creating multiple consent documents for multi-site studies using a 2-part consent template. I-Consent is a web-based platform to improve informed decision-making, leveraging multimedia and adult learning principles to communicate a concise consent summary. This presentation will provide a focused look at new technologies to support a clear and high-quality consent processes.

Discussion following the panel will be facilitated by the session moderator. Major points of discussion will be informed by attendee questions and experiences, and the different perspectives presented by panelists to improve informed consent forms and processes.