The informed consent process in a clinical trial should empower individuals to make knowledgeable decisions about their participation in a study and promote trust in the research process.

This, of course, is easier said than done. Many clinical trials are complex, which can lead to lengthy consent documents with abstruse medical jargon, making it difficult for participants to fully comprehend the study's risks, benefits, and procedures as well as their rights within the clinical research process.  

The Food and Drug Administration (FDA) and the Health and Human Services’ Office of Human Research Protections (OHRP) have released new draft guidance¹ that provides recommendations for making the information provided during the consent process as clear and easy to understand as possible, regardless of the complexities associated with participation. It sets the stage for a more inclusive, coherent, and participant-focused consent process. This guidance will influence how informed consent is obtained in future clinical research.
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Electronic or Paper?

While the FDA doesn’t overtly declare electronic consent, as opposed to paper documents, to be the preferred format, the agency does endorse the use of “innovative” and “flexible” methods to obtain consent.^1(p4) The draft guidance specifically mentions the use of electronic tablets as an example of this.^1(p4)  

Let’s dive deeper into what the FDA means by “innovative” and “flexible” methods.  
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Innovative Methods to Present Key Information

The FDA stresses that an informed consent document should be “presented in a way that does not merely provide lists of isolated facts, but rather facilitates” the prospective subject’s understanding, especially when outlining the trial’s key information, such as the study’s purpose, expected duration, procedures, risks, benefits, and the voluntary nature of participation.^1(p12) Note: This list is not exhaustive of a study’s key information, and the FDA recommends consulting with patient advisors to understand what points should be highlighted in the “key information” section.^1(p4)

The guidance advocates for the use of non-traditional methods to present information to prospective participants, saying new approaches can help to enhance comprehension.^1(p4)  

Here are some of the ways this can be achieved, according to the guidance.  
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Multimedia^1(p4): Consider the use of available technology to “provide key information that will help prospective subjects better understand the reasons why one might or might not want to participate in the research.” This includes integrating interactive elements, such as videos and other visual aids, into the consent process and using tools, such as electronic tablets, to present the information.  

Content Bubbles^1(p12): Consider organizing key information within a defined border, referred to as a “bubble.” This might include rounded boxes that create a “unit of information.” The FDA cites research that concluded consumers had better comprehension of prescription drug labeling when the content was provided in a “simple format, with information organized or grouped together within a defined border.”  

Bullet Points^1(p12): Consider the use of bullet points, formatting the material into two columns, and including ample white space between each piece of information. This can help make consent documents easier to read for prospective participants.  

Repetition^1(p5): Repeating important concepts can help clarify those concepts, and using hyperlinks to cross-reference information from the "key information" section to other sections with more details can be helpful.  

Content Tiers^1(p13-14): The guidance suggests organizing consent content into tiers for clarity and ease of understanding. The first tier should focus on key information essential for making an informed decision about participation. Subsequent tiers should provide more detailed content on study specifics, procedures, and additional information.

Understandable Language^1(p14): The FDA reiterates the importance of using understandable language when writing consent documents. The agency advocates for avoiding medical jargon and technical terms to facilitate informed decision-making.
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Conclusion

This new draft guidance from the FDA on informed consent highlights a shift towards leveraging technology to enhance the clinical trial process. This initiative encourages the adoption of new ways to present consent information, using modern digital tools and visual aids to improve understanding and participant engagement. By integrating interactive content, multimedia elements, and straightforward language, trial sponsors can make information more accessible. This approach not only aligns with the evolving digital landscape but also underscores the FDA's commitment to patient-centric research practices.
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Reference:

1. CDER, HHS. Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards. FDA. March 2024. Accessed March 22, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/key-information-and-facilitating-understanding-informed-consent-guidance-sponsors-investigators-and

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