How to Comply with FDA Guidance for Informed Consent Information Sheet: A Step-by-Step Guide

As a clinical researcher or medical professional, complying with the Food and Drug Administration (FDA) guidance is critical to ensure the safety and well-being of study participants. Informed consent is a critical part of any clinical study. An informed consent form (ICF) is a document that is signed by study participants or their legal representatives before entering into a clinical study. In order to comply with FDA guidance for informed consent information sheet, it is important that the ICF is accurate, clear, concise, and contains all the essential information required by FDA regulations.

Step 1: Understand the Basics of Informed Consent

Before you start creating your ICF, it is important that you understand the basics of informed consent. Informed consent is a process where the study participant understands enough information about the study including its purpose, procedures, risks, benefits, alternatives, and the rights that they have before deciding whether or not to participate in the study.

Essentially, informed consent is about making sure that the study participant has all the information they need to make an informed decision about participation in the study. This means providing the information in a way that is easy to understand and answering any questions that the participant may have to ensure that they understand all the information.

Step 2: Identify the Essential Elements of Informed Consent Information Sheet

When creating an ICF, it is important to include all the essential elements as required by the FDA guidance. These elements include:

• A statement that the study involves research
• The purpose of the study
• The duration of the study
• The procedures involved, including their frequency and duration
• A description of the risks and benefits involved in the study
• The available alternatives to participation
• A statement that the participant has the right to withdraw from the study at any time
• A statement that the participant’s confidentiality will be protected
• A contact person for questions about the study or participant rights.

By including all these essential elements, you can create a comprehensive ICF that meets all regulatory requirements.

Step 3: Create a Clear and Concise Informed Consent Information Sheet

When creating your ICF, it is important to keep it clear and concise. The ICF should be written with easy-to-understand language that is free of jargon, and should use uncomplicated sentence structures. Using short sentences and simple language can make it easier for the participant to read, understand, and sign the document.

Use headings and bullet points to make the ICF easy to read and understand. This can also help ensure that the participant is not overwhelmed by a large amount of text and can easily find the information they need.

Step 4: Use Case Studies to Illustrate the Importance of Complying with FDA Guidance

Case studies can be used to illustrate the importance of complying with FDA guidance for informed consent. For instance, in 2016, the FDA found multiple deficiencies in the informed consent process for a clinical trial. Some of the deficiencies included:

• ICFs that were incomplete or lacked essential information
• Failure to provide ICFs in the participant’s native language
• ICFs that did not include specific information on the use, storage, and disposal of biological specimens collected from participants.

As a result, the study sponsor was required to provide more comprehensive and updated ICFs to all the participants, and was also advised to create an institutional plan to prevent future deficiencies in the informed consent process.

Conclusion

Complying with FDA guidance for informed consent information sheet is essential for any clinical study. A well-written and accurate informed consent form helps ensure that study participants have all the information they need to make an informed decision about participating in the study. When creating your ICF, ensure that you understand the basics of informed consent, include all essential elements, keep the language clear and concise, and use relevant case studies to illustrate the importance of compliance.