Informed consent is a fundamental ethical and regulatory requirement for clinical trials. This process ensures that potential participants understand the key elements involved in a trial before deciding whether to take part. However, obtaining truly informed consent can be challenging, especially when many prospective participants have limited health literacy.
To address this issue, the U.S. Food and Drug Administration (FDA) released draft guidance that aims to improve participant comprehension during the informed consent process, in addition to harmonizing FDA requirements with the Health and Human Services (HHS) Common Rule. It is essential that researchers not only understand this updated guidance, but also how it impacts potential participants.
What Is Key Information, and Why Does It Matter?
Researchers who have been conducting research under the federal Common Rule regulations are already familiar with key information. The revised Common Rule, updated in 2017, requires the addition of “a concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representation in understanding the reasons why one might or might not want to participate in the research” at the start of consent documents. The FDA draft guidance released in March 2024 adds identical language.
Many informed consent documents are lengthy. One review examined COVID-19 vaccine trial documents specifically and found that the mean length was 8,333 words (approximately 16 single-spaced pages). Although providing relevant information for participants is essential, more information is not always better, as it can result in patients becoming overwhelmed or confused about what the trial involves and what it means for them. Adding key information makes it easier for potential participants to find the most important facts and to facilitate further discussion.
To be effective and in line with FDA guidelines, key information should be relatively short: less than a page for minimal risk studies and a few pages at most for more complex trials. The information presented also needs to be clear and accessible.
The Impact of Health Literacy
Health literacy is the ability to understand and evaluate information about health. Someone may be health literate in certain contexts but not others. For example, a person may understand general information about their diagnosis, but struggle in evaluating which treatment is best for them based on potential risks and benefits. Overall, nine out of ten adults in the U.S. struggle to some extent with health literacy.
In the context of clinical trials, low health literacy is a major challenge. For a participant to truly give informed consent, they need to understand what their role is, what intervention they may receive, the risks they face, and how the trial could affect their condition.
Tips for Improved Communication of Key Information
In line with recent FDA guidance, researchers need to consider health literacy throughout the process of drafting key information documentation.
Some strategies to do this include:
- Simplify language wherever possible. For example, the average participant may not recognize the word “pharyngitis,” but they probably know what a sore throat is.
- Use key information to open discussion, not as the final step. Cultivate an environment where participants feel comfortable bringing forward concerns and asking questions.
- Use multimedia and engaging formats. Reading a block of text can quickly become overwhelming; using videos, diagrams, illustrations, or other ways to present information can help emphasize key points and keep participants engaged.
The Role of Researchers
The role of researchers who are “in the room” with participants, whether literally or figuratively in the case of decentralized trials, is essential to complement and build on the goals of written documentation. They must be prepared to convey information in a clear, accessible manner that accounts for varying levels of health literacy among potential participants.
This process includes building trust and honoring trust once it is built. For many in the general public, doctors and healthcare providers are seen as authority figures whose guidance carries substantial weight. This can create a risk of therapeutic misconception, where patients perceive being invited to join a trial as a recommended treatment endorsed by their doctor. Communicating plainly about the distinction between research and clinical care is essential.
Conversely, many communities may have doubts about research or healthcare providers in general. In these cases, working with leaders to understand what the community needs and how to engage collaboratively is an important first step.
Researchers also play a role in determining whether patients have understood key information. Adopting techniques like the “teach-back” method, where participants rephrase details in their own words, allows researchers to verify comprehension throughout the consent process. An open, supportive dialogue helps identify areas of confusion and enables researchers to adapt their approach for each participant’s needs.
Integrating Advanced Technology for Informed Consent
While the human element of informed consent is undoubtedly important, advancements in technology are also relevant. Electronic consent solutions allow for an interactive, multimedia experience integrating animations, pop-ups, videos, and more to convey complex concepts visually and engage participants.
AI can also play a role, providing opportunities to automatically simplify phrasing and optimize information for researchers and patients. Although this technology is still developing, it is a promising avenue to alleviate some of the burden on researchers.
Additionally, as younger, more tech-savvy generations become potential participants, embracing these digital solutions may become essential to meet expectations around user experience and accessibility of information.
Elevating Informed Consent Through Patient-Centric Design
While complying with FDA guidance is crucial, the larger purpose of key information goes beyond checking regulatory boxes. Integrating health literacy considerations brings researchers closer to realizing the principle of informed consent in both letter and spirit.
Sterling IRB can help you navigate informed consent. Our expert team stays ahead of the latest regulatory guidance and partners with you to streamline your research process while safeguarding the rights and welfare of participants.
Contact us to explore our solutions.