Unpacking FDA’s New Guidance on Facilitating Understanding in eConsent

Informed consent is not just a procedural formality but a basis of ethical practice, ensuring that participants fully understand the implications of their involvement. The Food and Drug Administration (FDA) recently issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent,” to refine this process, providing sponsors, investigators, and Institutional Review Boards (IRBs) with a comprehensive framework to enhance participants’ understanding of clinical trials. Here, we delve into the key recommendations from this guidance and how it applies to eConsent.

Concise and Focused Presentation of Key Information

The FDA emphasizes the need for the informed consent process to begin with a concise and focused presentation of key information. This approach aims to prevent information overload, ensuring that participants can easily grasp the most critical aspects of the trial and make the decision-making process more manageable. Moreover, the guidance suggests including supplemental information that might influence a participant’s decision, such as the most significant risks associated with investigational medical products, research procedures, or other study-related aspects.

To ensure the informed consent process can begin with a concise and focused presentation of key information, various techniques can be utilized to streamline and enhance participant comprehension (see next section for ‘bubbles’ strategy recommended by FDA). A tiered approach to information presentation can help by initially summarizing the most critical aspects of the study, such as its purpose, risks, benefits, and participant obligations, in an easily digestible format. Bullet points and bold headings can further enhance readability, drawing attention to essential information and ensuring that participants can quickly grasp the key aspects of the trial. Incorporating these techniques ensures that the consent process respects the participant’s time and cognitive load and empowers them with the knowledge needed to make informed decisions about their involvement in clinical research.

Flexible Approaches to Providing Key Information

Recognizing the diversity of clinical research and its subjects, the FDA encourages flexible approaches to presenting key information. The FDA recommends using defined borders, such as ‘bubbles,’ to organize information within the consent form. This visual separation helps participants distill complex data into more manageable sections, making it easier to comprehend the information presented.

Incorporating the concept of using bubbles for key information within an eConsent format, the approach becomes interactive and user-friendly. Imagine an eConsent interface where each ‘bubble’ represents a core component of the study—such as objectives, procedures, risks, and benefits—outlined in visually distinct sections.

For instance, if a participant wishes to delve deeper into the potential risks associated with the study, they can select that specific bubble, which expands to provide comprehensive details in an easy-to-digest format, perhaps supplemented with multimedia elements like short videos or infographics. Similarly, interactive quizzes or prompts for feedback can be embedded within these bubbles to assess and reinforce understanding, ensuring participants are fully informed. This eConsent adaptation of the bubble format can leverage digital capabilities to enhance participant engagement and comprehension, making the consent process more intuitive and effective.

A recent Medable and Duke University study provides compelling evidence for the effectiveness of enhanced eConsent solutions, demonstrating that participants preferred these versions and felt better informed by them. This study highlights the capacity of eConsent platforms, enriched with interactive digital elements, to cater to the varied needs of participants, thereby improving their comprehension and readiness for clinical research. The clear preference for an enriched eConsent version over a traditional text-only format proves the significant potential of digital eConsent enhancements to meet FDA recommendations, thereby elevating participant understanding and engagement in clinical trials.

Cultivating Deeper Understanding

The guidance goes beyond the key information section, offering strategies to ensure the entire consent form is conducive to understanding. This involves presenting information in sufficient detail and in a logically organized manner that helps prospective subjects grasp the reasons for their potential participation. It highlights the importance of using understandable language and considering the needs and characteristics of the target population, which may include their educational background, language proficiency, and cultural context.

In eConsent formats, adaptive content can cater to users’ preferences, offering language options or adjusting the complexity based on the participant’s education level indicated at the start, for example. Additionally, virtual tours of study procedures can vividly elucidate what participation involves, enhancing understanding. Moreover, incorporating strategies for testing comprehension is crucial to ensure participants fully grasp the consent information. Interactive quizzes or the teach-back method in eConsent platforms can confirm understanding, allowing for real-time feedback and clarification. This ensures that consent is informed and comprehended, aligning with the ethical foundation of clinical research.

The enhanced eConsent version evaluated in the Medable and Duke University study also personalized the consent process, increasing participant comfort and engagement. Incorporating interactive and adaptive content, this approach exemplifies the FDA’s recommendation to make consent information meaningful and accessible. Furthermore, the study’s use of analytics to understand participant interactions offers valuable insights into optimizing eConsent solutions and study comprehension, ensuring they cater to individual needs and preferences and offering researchers a feedback loop to amend the eConsent for better participant understanding.

Summary

The FDA’s draft guidance on informed consent, emphasizing concise, focused presentations and flexible approaches to key information, represents a significant advancement in the ethical practice of clinical research. This guidance, mainly when applied to eConsent platforms, has the potential to revolutionize the informed consent process, making it more accessible, engaging, and understandable for participants. The innovative use of digital elements, as demonstrated in the study by Medable and Duke University, proves the effectiveness of such approaches in enhancing participant comprehension and engagement. By adopting strategies like the bubble format and incorporating interactive elements, eConsent platforms can tailor the consent process to meet diverse participant needs, fostering a deeper understanding of clinical trials.

This article is sponsored by Medable