02/26/2025
On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
The first presenter, Lana Escamilla, shared her insightful perspective of the informed consent process through the lens of someone who has participated in multiple clinical trials. Diagnosed with Wilson’s disease at a young age, she recalled the details of what it was like to be approached for the clinical trials, how the informed consent form (ICF) was presented and explained, and her thoughts and feelings about the overall experience looking back. She emphasized how much her relationship with her physician helped her through it all by addressing any questions or concerns she had. She also pointed out details that could have gone better, questions she would have asked in hindsight, and areas that future informed consent processes could improve upon.
The following presentations were by FDA staff Ann Meeker-O’Connell and Suzanne Pattee from the Office of Clinical Policy, who elaborated on the FDA’s perspective on ICFs and the informed consent process. Ann covered the principles and elements of informed consent; she listed the following:
8 basic principles of IC
1. A statement that the study involves research
Explanation of the purpose / expected duration
Description of procedures/research interventions
The ICF needs to written in plain language that someone without a scientific background can understand.
2. Reasonably foreseeable risks or discomforts
They explained that in is not necessary to over describe and exhaustive list of every potential risk as this can quickly overwhelm the reader, instead, focus on the more common and relative risks.
3. Reasonably expected benefits to the subject or to others
4. Disclosure of appropriate alternatives
5. Confidentiality/FDA may inspect
6. Compensation and research-related injuries
7. Point of contact for questions
8. Participation is voluntary
Additional Elements (When Appropriate – paraphrased)
1. A statement that the particular treatment or procedure may involve unforeseeable risk to the subject (or embryo or fetus)
2. Circumstances of study termination
3. Costs to the subject
Here they stress the need for both direct and indirect expenses to be explained such as travel time or time away from work.
4. Consequences of withdrawal
5. A statement that significant new findings relating to the subject’s willingness to continue will be communicated
6. Approximate number of subjects in the study
Suzanne then focused on the participant experience side as well as opportunities for innovation and improvement, she expressed the following:
ICF structure and content should be flexible to fit the unique properties of the trial.
It is important to find a balance between meeting the regulatory requirements mentioned above while keeping it short and concise. Suzanne gave the example of the “participation is voluntary” component and how it does not need to be more than a few sentences as opposed to multiple paragraphs.
Make full use of technologies available.
ICFs can include videos, diagrams, and audio to facilitate understanding.
Electronic ICFs can make it easier to read. The example used was font size, those who have visual impairments may need much larger fonts to read the ICF which is easily changed in a pdf format.
Trust is essential for improving the participant’s experience
Research staff selected to explain the informed consent MUST demonstrate empathy, compassion, and caring for the participant in order to build trust. Additional training may be required to accomplish this.
Consider a “Key Information” section to facilitate understanding
Included at the beginning of the ICF, it should be a short concise outline of the study and reasons why someone may want to participate.
This does not replace any section of the ICF, rather, it should highlight important sections to facilitate understanding.
The FDA draft guidance “Key Information and Facilitating Understanding in Informed Consent” is a great resource for understanding this concept.
The entire webinar is an hour and can be found on YouTube, the slides and transcript is on the FDA website. Informed consent process has been essential for every clinical trial since it was first described in the Nuremberg Code in 1947, continuing to review and improve on these processes will not only uphold trial participant’s rights but will also encourage future participation. Participation in a clinical trial may be during an abrupt change in an individual life, whose only experience with healthcare may have been routine checkups with a family doctor, as was the case for Lana who had been a relatively healthy individual up until her diagnosis. Having a smooth and transparent informed consent process in place and ensuring the research staff demonstrate authentic kindness and compassion for each prospective participant can help to ease the concerns and stress that, for many, comes with being in a clinical setting. The webinar does a fantastic job at elaborating on these points and providing further resources on how clinical research stakeholders can develop their own informed consent process as well as contribute to future innovations of informed consent within the clinical research ecosystem.
-The Clinical Pathways Team
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