October 30, 2024
Hello, my name is Tess Robertson-Neel, and I am the manager of the Patient, Consumer, & Public Health Coalition, which is an informal coalition of more than 2 dozen nonprofit organizations that focuses on ensuring safe, effective, and affordable medical and consumer products. The coalition does not accept funding from entities with financial ties to the products that we deal with.
Our coalition appreciates the FDA’s efforts to improve informed consent in clinical trials of medical devices and all the suggestions made in this mornings’ presentations. We support the suggestions made in the draft guidances on informed consent, but we encourage the agency to either make these recommendations enforceable or create incentives to maximize compliance.
My experiences in public health research and study design have highlighted the complexities of getting true informed consent from participants. True informed consent is a process that should meet participants where they are, it is not just information on a piece of paper. We agree with the FDA that there is a need for improvement. We’ve worked with thousands of patients, and they tell us that informed consent documents are often too long, technical, and/or confusing for most patients to understand. As we all know, the longer the informed consent documents are, the less likely they are to be read. CDRH has attempted to improve the process for devices that have been cleared or approved by using patient information checklists, which we support in the post-market environment and think would also be helpful to improve informed consent during clinical trials when there are many unknowns about risks and benefits.
The checklist format could include numerous facts, and the patient must initial each fact separately to show that they have read it. The healthcare provider or study representative must also sign the checklist to indicate that they provided the same information orally. However, checklists can also be too long, including information that is either self-evident or not obviously relevant to a patient who is trying to decide whether to sign it or not. Moreover, when CDRH provides a sample checklist but allows a company to revise it however they choose, that may not protect patients from misleading or confusing information. For that reason, a patient information checklist must include certain information in a specific format to ensure that the patient has all the key information about the trial and what is known and not known about the device. Most important, the information that the health professional provides orally to the patient should be virtually identical to the information provided in writing.
The average reading level in the U.S. is 7th-8th grade and that means that half of all Americans read below that level. This checklist or any other information provided to ensure informed consent must therefore be simple, to the point, and easy to understand.
Thank you for the opportunity to share our views today.