In August 2023, the FDA provided a significant update to its Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors. The new guidelines replace the FDA’s 1998 guidance, “A Guide to Informed Consent”, and finalizes the FDA’s draft guidance, “Informed Consent Information Sheet”, released in July 2014.
Key Updates and How they Impact Clinical Trials
Alternative Methods of Obtaining Informed Consent
While traditional paper consent is still widely used, the FDA recognizes the demand for alternative methods. With the rise of decentralized and fully remote trials, eConsent considerations are seeing rapid adoption. The key, as stipulated in 21 CFR 50.20, is that the method should adequately allow subjects to understand the research implications, ensuring their rights, safety, and well-being are prioritized.
Dating the Consent Form
The emphasis on dating the consent form is underscored in the 21 CFR 50.27. This requirement ensures that there’s a clear record of when a participant gave their consent, offering a timeline of the participant’s involvement and safeguarding their rights in the process.
Forms for Documentation of Informed Consent
According to 21 CFR 50.27, documenting informed consent isn’t just about getting a signature. The consent form should be detailed, yet comprehensible, ensuring that participants can make an informed decision. The consent form should be in a language understandable to the participant, with a copy retained by the participant and another stored securely by the investigator.
Enrolling a Child in Clinical Investigation
Children represent a vulnerable group in clinical trials. As per 21 CFR 50, Subpart D, additional safeguards have been put in place. Investigators should ensure that clear consent from the child and permission from the parents are obtained. The process should respect the child’s autonomy while ensuring they are protected from potential harm.
Additional Protections for Wards of the State
Children who are wards of the state exhibit specific vulnerabilities. In line with 21 CFR 50.56, such children can only be involved in trials if the research is related to their status as wards or is conducted in settings like schools where the majority of children aren’t wards.
Considerations for Low Literacy and Numeracy Subjects
The FDA emphasizes inclusivity in trials. However, this can bring challenges, especially with low literacy participants. To ensure understanding, investigators may consider simpler language, visual aids, or even verbal explanations. To meet the stipulations of 21 CFR 50.20 is crucial: every participant, regardless of their literacy level, should comprehend the study implications.
Electronic Methods for Obtaining Consent
As technology advances, eConsent is gaining ground as a common practice. The FDA’s position, aligned with 21 CFR Part 11, is that electronic methods can be as valid as paper-based methods, provided they ensure the participant’s understanding and voluntary participation. This includes clear electronic signatures, timestamps, and secure data storage.
Handling Data Post-Withdrawal
When a subject withdraws from a trial, 21 CFR 56.113 provides a clear directive: while investigators can keep already collected data, they shouldn’t continue collecting data without explicit consent. Communication is crucial during withdrawal to understand the participant’s wishes regarding their data.
Review of Patient Records & Informed Consent
Per 21 CFR 50.23, informed consent is typically required to access patient records. There are exceptions, such as life-threatening situations or when the participant is unable to provide consent. However, these exceptions are narrow, emphasizing the sanctity of patient data.
Updating Subjects on New Research Information
When new information arises that might influence a participant’s decision to stay in the trial, they must be clearly informed. While “reconsent” is not explicitly defined by the FDA, 21 CFR 50.25 imposes a clear responsibility to inform participants and enable them to revise their decisions regarding participation.
Alethium’s Intelligent Consent Tools
Alethium’s global consent solution accommodates paper, hybrid, or fully remote eConsent aligned with current regulatory guidelines. The platform is built to handle diverse consent types, multiple languages, and unlimited documents.
Providing a full suite of fail-safes to prevent deviations and deliver top-tier efficiency, Alethium ensures a seamless user experience for investigators, sponsors and, especially, participants.
Learn how Alethium can support your next global trial. Schedule a demo today!
