FDA Guidance Breakdown: Key Information and Facilitating Understanding in Informed Consent

A new draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects by HHS and identical provisions of a proposed FDA rule.

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On February 29th, the FDA published a draft guidance that aims to make it easier for clinical trial participants to understand informed consent, offering trial sponsors recommendations for clarifying key information.

This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.” The FDA’s proposed rule, if finalized, would harmonize certain sections of FDA’s regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act. The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.

The 19-page draft directs sponsors, investigators, and IRBs to clearly present participants with information on the research — and do so in a way that's understandable to them. This can include information about the research goals, the project length, and the risks and benefits of participation.

“The presentation of key information at the beginning of the consent process can help facilitate discussions between a prospective subject and an investigator about whether the prospective subject should participate in the trial,” the FDA wrote. “This information also may be useful to enrolled subjects as a resource and to facilitate any further discussions with investigators.”

The guidance recommends that sponsors keep key information in a consent document to no more than a few pages. It also recommends that sponsors consult with patient advocacy groups and potential participants to determine their views on that information in the research project.

In case your time is short, here's a quick summary of its policy contents, along with a handy checklist for assessing your current alignment:

Introduction and background

The guidance addresses provisions of the HHS regulations on protecting human subjects and proposed revisions to the FDA’s regulations. It emphasizes the presentation of key information in informed consent documents to assist prospective subjects or their legally authorized representatives in understanding the reasons why one might or might not want to participate in research.

The FDA says it aims to facilitate discussions between prospective subjects and investigators, ensuring informed consent information complies with 45 CFR 46.116(a)(5) and the proposed revisions to 21 CFR 50.20(e).

Key information section

The “Key Information Section” emphasizes a subject-centric approach in presenting crucial details that aid prospective subjects in making informed decisions about participating in research.

Flexible approaches

• Innovative presentation: Encourage using multimedia resources like videos, infographics, and interactive electronic tablets to convey key information effectively. This could include animated summaries of the study's purpose, procedures, and potential risks and benefits.

• Engagement with patient groups: Before finalizing the consent form, consult with patient advocacy groups or a sample of the target population to gain insights on the clarity and effectiveness of the presented key information.

Identifying key information

• Introductory statement: Begin the consent document with a clear, concise statement that frames the forthcoming information, helping to set expectations for the reader. This statement should highlight the significance of the information and its intent to assist in decision-making.

• Prioritization of elements: Prioritize including elements in the key information section based on their importance to the specific study and its prospective subject population. This prioritization should reflect the unique aspects of the study design, the condition under investigation, and the subject population's characteristics.

Specific recommendations

• Voluntary participation and discontinuation: Use clear, non-technical language to emphasize that consent is not a contract, and participants have the right to withdraw their consent and discontinue participation at any stage without any negative consequences. Explain the process for withdrawing from the study, including whom to contact and any necessary steps or documentation, ensuring participants understand how to exercise this right effectively.

• Research purpose, duration, and procedures: Summarize the study's aim, expected duration, and the procedures that participants will undergo. Use lay language to describe the study's design, including any randomization or placebo aspects.

• Foreseeable risks and discomforts: Highlight the most significant risks and discomforts associated with the study, prioritizing them by severity or frequency. If comprehensive risk details are provided elsewhere, include a direct reference to the location (e.g., page number or section) where participants can find this information, ensuring they have full access to all relevant data.

• Expected benefits: Carefully distinguish between the potential for direct benefits to participants, which may be uncertain, and the broader benefits to scientific knowledge or future patients to prevent therapeutic misconception. Where benefits are speculative or part of the research hypothesis, explicitly state this to manage expectations about participation outcomes.

• Alternative procedures: Provide a brief overview of available alternatives to participation, including standard treatments or other ongoing studies, focusing on how these differ from the study intervention regarding risks, benefits, and procedures. Offer guidance or resources for participants to further explore these alternatives, potentially including consultations with their healthcare providers.

• Compensation and treatment for injuries: Specify the types of compensation participants may receive, such as reimbursement for travel expenses, stipends for time and inconvenience, or other forms of compensation. Clearly outline the provisions for medical care in the event of research-related injuries, including what treatments are covered, the process for obtaining care, and any limitations or conditions attached to this coverage.

• Costs of participation: Enumerate any costs that may fall to participants, including those not covered by the study (e.g., travel, accommodation, incidental expenses) and any potential impacts on insurance premiums or coverage. Detail the reimbursement process for study-related expenses, including how to submit claims, types of expenses covered, and timelines for reimbursement to ensure participants are fully informed about the financial aspects of their participation.

Supplemental information

Include additional information that might influence a subject's decision to participate.

This could involve:

• Data privacy and sharing: Explain how personal and health information will be protected and potentially shared.

  • Clearly outline the measures in place to ensure the privacy and security of participants' personal and health information. This includes data encryption, access controls, and compliance with relevant privacy laws and regulations.