04/09/2024
Photo by Arisa Chattasa on Unsplash
Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
To help prospective participants better understand ICFs the US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) developed the draft guidance document: “Key information and Facilitating Understanding in Informed Consent.”
The draft document outlines ways investigators, sponsor, and institutional review boards (IRB) can meet the two proposed requirements of the FDA proposed rule: “Protection of Human Subject and Institutional Review Boards”, as well as the existing two requirements of the revised HSS Common Rule:
1. Key Information: Key Information about the essential details of a trial (reasons for and against why a prospective participant may want to participate) must be presented at the beginning of the ICF.
2. Facilitating Understanding: The information within the ICF must be presented in a way that facilitates the prospective participant to fully understand what it is they are consenting to.
For the key information requirement, the draft provides suggestions on how to identify key information, which may include:
Purpose of the study
Estimated duration of the study
Potential benefits and risks the IP or device may have on the participant’s physical or mental wellbeing
Any financial cost the participant may incur
For Facilitating Understanding, the draft breaks down why participants may have trouble comprehending an ICF and provides actionable solutions that include:
Avoiding listing out the individual facts of a trial and instead incorporating the facts into text that better describes the facts and how they relate to the goals of the trial
Using “Bubbles” to break up the key information instead of MedGuide style block format
Using plain language that any participant with no scientific background can comprehend while still providing sufficient detail
The draft also provides alternatives to paper ICFs (see our previous blog entry on the value of electronic consent here) that may include:
Oral presentations
Electronic tablets
Illustrations
Videos
The full draft guide and supplementary information can be found on the FDA’s website. The draft is open to comment submission until April 30th, 2024 here. Know of other approaches to improve patients understanding of ICF? We would love to hear from you!
-The Clinical Pathways Team
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