Overview
In a significant move towards enhancing the transparency and effectiveness of informed consent processes in clinical research, the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have unveiled a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.”
This draft guidance is in response to the revised Federal Policy for the Protection of Human Subjects, commonly known as the revised Common Rule, by the U.S. Department of Health and Human Services (HHS). Additionally, it aligns with identical provisions within the FDA’s proposed rule “Protection of Human Subjects and Institutional Review Boards.”
Primary Focus
This draft guidance’s primary focus is on improving the initial phase of informed consent, ensuring it begins with key information about the research and is presented in a manner that fosters comprehension among prospective participants. Harmonizing certain sections of FDA regulations with the revised Common Rule aims to streamline the informed consent process while maintaining compliance with statutory provisions and the 21st Century Cures Act.
Key Recommendations
Key recommendations outlined in the draft guidance include strategies for developing a key information section for clinical trials or studies. Drawing from research on patient understanding of prescription drug labeling, the guidance emphasizes using plain language principles and formatting techniques to enhance comprehension. Notably, presenting information in a discrete bubble format, with logically organized topics, has shown promise in facilitating consumer understanding.
Conclusion
As the landscape of clinical research evolves, initiatives like the draft guidance on enhancing understanding in informed consent play a crucial role in safeguarding the rights and well-being of research participants while advancing scientific knowledge for the greater good.
Interested parties are invited to provide feedback during the 60-day comment period, which concludes on April 30, 2024. Visit the NIH notice for additional information.
