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Informed Consent Simplified
(Thursday, March 7, 2024) There are a few important considerations for the Informed Consent Document (ICD), also called the Informed Consent Form (ICF), used by sponsors to consent clinical trial participants which could improve the quality of the consent process and possibly increase trial participation. The design of the ICD varies extensively due to the experience of the sponsors and study teams. This week’s FDA guidance document discusses the nuance of the ICD/ICF to better explain the intent of the regulators. There are several opinions about the inclusion of content, the details of the study procedures, and the length of the ICD used to consent patients. This has led to ICDs being long, highly technical, and onerous for the study participants to understand, and for the study teams to explain to the potential participants. That’s not the intent of the regulations or the Good Clinical Practices (GCP) guidance documents. Over the years, the FDA has published a few guidance documents to explain the requirements for ICDs and the process to consent participants. The latest guidance adds on to those previous guidance documents. The new guidance document’s intent is to suggest how the information included in the ICD could be worded and organized to increase its understanding by the potential participants. The guidance document suggests that key information about the trial, such as the background of the investigational product, the purpose of the trial, the key procedures that be conducted, possible risks, and some other important information be presented at the beginning of the ICD and simple wording and not to exceed a few pages in length. The key suggestion from the guidance is to consider multiple formats for the ICD such as a combination of written, oral, or media (illustrations or video) and electronic consent when describing the trial. FDA suggests that combining text-based and visual information, using bullets to break complex information into understandable groups, and using simple language, would increase the comprehension of the participants about the trial. The most important suggestion is to include a “bubble format with rounded boxes capturing a discrete unit of information” which may improve comprehension and make documents easier for people to read and understand. A template for the bubble format is provided in the guidance document. The guidance builds on previous guidance on the overall process of informed consent, the content to the included in ICDs, electronic informed consent, and ICDs in special circumstances. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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