The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services (HHS). The draft guidance endorses the use of formats that will facilitate understanding of the risks and benefits of taking part in the trial, such as the use of information bubbles.
The draft guidance was issued jointly by the FDA and the HHS Office for Human Research Protections and will align the FDA’s requirements for IC with those of the HHS Common Rule for patient protections in clinical trial research. The FDA had released a final guidance in August 2023 that also addressed questions of IC, although the August 2023 guidance pertains to IC compliance requirements for institutional review boards, clinical investigators and sponsors of clinical studies.
This new draft guidance provides recommendations for the development of a key information section in IC documents. The FDA based the recommendations in the draft guidance on the agency’s research into patient comprehension of various
types of materials, including information found in prescription pharmaceutical labels. The objective of the final version of this draft guidance will be to assist clinical trial sponsors in providing potential study participants with information that will aid in the decision whether to take part in a clinical study.
The draft version recommends the use of a defined border, or bubble, to present discrete units of information in an IC form. These discrete bubbles may be used to highlight information such as the purpose of the clinical study, the potential risks of participation, and the availability of alternative therapies. The agency states that the addition of white space around a discrete bubble can improve readability.
The FDA offered alternatives to the bubble format for presenting critical information, such as text that is formatted into two columns with bullet points. This approach might lend itself to the task of condensing complicated information into more a more comprehensible format. One of the features of the FDA draft that aligns with the Common Rule, as amended by the 21st Century Cures Act, is that information presented in IC forms must provide content in what the FDA said is a sufficient level of detail. This requirement may be fulfilled by the addition of a section specifically labeled as key information.
Another point of alignment with the Common Rule is the requirement that IC documents be organized in such a way as to facilitate the potential study subject’s understanding of the reasons for taking part in the study. This requirement may be fulfilled by a tiered approach to the organization of information. The first tier would provide the most critical parts of the information required by the FDA while a second tier, if needed, would provide the remaining required information. A third tier could provide additional details that are required by the regulation or other information, such as a glossary of terms. The FDA recommends that sponsors add a table of contents and page numbers to cross-reference related topics, or alternately the use of hyperlinks in electronic documents.
The FDA emphasizes the need for IC documents to use language that is likely to be understood by prospective enrollees, which includes considerations such as English language proficiency. Among the methods for testing an IC form’s comprehensibility are engaging with patient advocacy groups to review IC forms, and presenting the form to a sample of the population that would enroll in the clinical study.
This draft guidance applies to IC forms used in studies of pharmaceuticals, medical devices and biotechnology therapies, as well as combination products based on these product categories. The FDA is accepting feedback from stakeholders through April 30, 2024.
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