This CLE webinar will provide a detailed look at the FDA's recently released final guidance on informed consent for clinical investigations that reflects the technological and scientific advances made since the draft guidance was originally released in 2014. The panel will address notable changes and updates including those related to the responsibilities of IRBs, clinical investigators, and sponsors and educating research subjects. The panel will also discuss the relation to the 2018 Common Rule and describe best practices for compliance.
On Aug. 15, 2023, the FDA released Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors providing final guidance on informed consent for clinical investigations (the final guidance). In the nearly 10 years since the draft guidance was released, the processes by which clinical trials and human subject research are conducted have evolved with expanded scientific knowledge and technological advances. Therefore, the final guidance reflects those changes and provides important clarifications and examples for IRBs, investigators, and sponsors to ensure compliance.
The final guidance summarizes the informed consent process and outlines the FDA's informed consent requirements; addresses the responsibilities for IRBs, clinical investigators, and sponsors; and concludes with a series of updated FAQs. Notable and substantial updates from the initial draft guidance include: streamlining IRB review of consent forms; using innovative methods and technologies in informed consent to assist with communicating and educating research subjects; determining what constitutes coercion and undue influence in obtaining informed consent; and disclosing possible conflicts of interest to subjects.
Healthcare counsel and their clients should understand the final guidance and the noteworthy updates so that they can review current policies, procedures, and consent forms for compliance. Counsel should also be aware of how the new guidance relates to the 2018 Common Rule and how this may affect future FDA rulemaking.
Listen as our expert panel provides a detailed look at the FDA's final guidance. The panel will address notable changes and updates in the final guidance from the initial draft guidance, discuss the relation to the 2018 Common Rule, and describe best practices for compliance.
