FDA Modernizes Informed Consent Guidance, Aligning with Common Rule Changes

The U.S. Food and Drug Administration (FDA) has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand.

The 16-page guidance, which stresses flexibility in presenting information and encourages sponsors to “develop innovative ways and utilize available technologies to provide key information that will help prospective subjects better understand the reasons why one might or might not want to participate,” includes sections on key information and facilitating understanding of that information. For example, FDA believes sponsors should think about using alternative methods for presenting core information in an understandable way such as by consulting with patient advocacy groups and/or potential patients to gather their perspectives. “The key information section could also be presented using alternative media such as illustrations, video and electronic tablets to meet the goals of improving clarity and increasing prospective subjects’ understanding of consent information,” the guidance adds.

The guidance delves into key elements of informed consent and how to best present them to potential participants:

• Voluntary participation and the right to discontinue participation
• The trial’s purpose, expected duration and procedures
• Reasonably foreseeable risks and discomforts
• Reasonably expected benefits
• Appropriate alternative procedures
• Compensation and medical treatments for trial-related injuries
• Participation-related costs

On facilitating understanding, the guidance recommends taking a simple, concise approach by placing information in rounded boxes — “bubbles” — or another format that makes the information easy to read and understand. A two-column text approach, bullet points and “ample white space or empty space around discrete bubbles” can also suffice. The section also includes recommendations on the organization and presentation of the consent form, stressing the use of plain language that combines text with visuals.

FDA also finalized its guidance on pharmacology considerations for antibody-drug conjugates. Changes from draft to final include:

• Terminology updates and editorial changes for better clarity
• Additional references to FDA guidances
• Additional considerations for dosing strategies     ❖