The U.S. Food and Drug Administration (FDA) unveiled a new set of guidelines on August 15, 2023, concerning informed consent, building upon their 2014 draft. The release is a testament to the FDA’s dedication to refining the procedures around clinical trials. In this post, we’re spotlighting the major takeaways from these updates.

Key Themes in the Final Guidance

  1. Modernizing informed consent. The emphasis is on utilizing technology, streamlining the consent form approval process, and ensuring patients clearly understand what they’re agreeing to.
    • Electronic methods over paper. The FDA acknowledges the evolution of informed consent, especially in scenarios like contagious disease outbreaks. For instance, a photographed signed consent form, paired with an authenticity statement, can now replace traditional methods. However, solely verbal consents over phone calls don’t make the cut.
    • Consent form approval made easier. The final guidance simplifies the process by stating that institutional review boards (IRBs) no longer need to scrutinize nonessential changes or translated versions of consent forms. Only substantial updates should undergo IRB review, while minor changes can be updated directly.
  2. Clear communication with patients. The goal is to bolster patient comprehension by implementing communication aids and making sure patients understand all of the information relevant to their participation in the study. Along these lines, the FDA includes the following suggestions:
    • Visual aids. Using visual tools such as diagrams, videos, and other aids can help explain complex concepts to patients. Customizing the content to cater to specific audiences, like using enlarged font sizes or audio recordings, is also encouraged.
    • Updates and new findings. It’s paramount to update patients about major discoveries, especially those affecting their decision to participate. While trivial updates need not be communicated, pivotal information, including study-related risks and other crucial changes, must be shared transparently.
  3. Defining roles in the informed consent process. The final guidance aims to clarify the roles each person plays in the informed consent process by providing instructions relating to (1) the person obtaining the consent, (2) the translator (if applicable), and (3) the witness in cases of a short form consent process.
  4. Acknowledging sponsor practices. The changes acknowledge the existence of sponsor practices that are common in clinical investigations. Specifically, the FDA addresses the use of template consent forms and the involvement of sponsor personnel in study activities.
  5. Changes in the legal and regulatory landscape. The guidance addresses recent changes in the legal and regulatory landscape, particularly in the following areas:
    • Privacy.
    • Conflicts of interest, like an investigator having a stake in the product under study or owning part of the sponsoring company.
    • Subject withdrawal from the trial and how to treat their data post-withdrawal.
    • Undue influence, which can be context-specific, like when consent for extra tissue samples for research is sought just before a surgical procedure.
    • Circumstances in which the FDA may not strictly enforce informed consent rules, such as for previously gathered human specimens used in FDA-regulated diagnostic device studies, as long as the specimens cannot be traced back to individuals.
  6. Addressing special scenarios. The FDA also touches on unique circumstances that might arise in the research process. These scenarios include:
    • Special circumstances in which one person co-enrolling in more than one study simultaneously may be acceptable, although it is generally discouraged.
    • Indirect costs of which participants should be made aware, such as time off work or child care.
    • Risks and benefits in the standard of care.
    • Unapproved uses of an FDA-approved drug or device when such use is considered standard of care.

The final guidance contains updates, clarifications, and additional details aimed at modernizing and streamlining the informed consent process for all parties involved while simultaneously increasing transparency and understanding for study participants. The FDA intends for the guidance to assist IRBs, clinical investigators, and sponsors in complying with FDA’s existing informed consent regulations for clinical investigations. Institutions are advised to familiarize themselves with the guidance and review their internal informed consent processes, policies, and forms to ensure alignment with the final guidance. For additional information, please see our article on the topic.