October 30, 2024
Hello, my name is Laura Lytle. I am the Health Policy Director for the National Center for Health Research (NCHR), a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies, treatments and products are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
I am grateful for the time today to share NCHR insights and to underscore the importance of strengthening patient informed consent. We applaud the FDA’s efforts to provide a framework to improve patient informed consent and transparency. We support the suggestions made in the FDA’s draft guidance on Key Information and Facilitating Understanding in Informed Consent. We wish to provide insight today on ways to codify the FDA’s guidance to provide meaningful and impactful improvements to the consent process.
- Checklist. True informed consent requires a typical patient to easily understand the medical device they are considering. We support FDA’s previous use of patient information checklists to ensure informed consent for products already on the market and urge that this model be used in clinical trials to ensure that all key information is easily conveyed and understood by the patient. Short checklists consisting of a sentence or two for each key fact allows for the patient to pause and digest information and sign their initials before moving on to the next checklist item.
- Process. Informed consent is supposed to be a process, not a presentation of long, complicated documents filled with legal and technical terms that the patient must sign without having the time and/or ability to fully understand and consent. The process should include both oral and written components. Patients rarely read lengthy informed consent documents and are more likely to ask questions during an oral discussion of the risks, benefits, rights and responsibilities of a clinical trial.
- Key Information. Key information should inform patients of details they likely would not know and inform patients of what is known and not known about the potential benefits and risks of participation.
- Patient privacy and access to their information, especially how the data is stored, who has access and what the patient will be provided with their information during and after the conclusion of the study. This is especially true for post market research in medical devices.
Thank you for the opportunity to speak with you today, we thank the FDA for their efforts to provide guidance in order to improve and standardize the informed consent process.