Dr. Wendy Tate of Forte answers attendee questions following her recent webinar “Making Your Consent Forms Readable: The Why and the How.” In her webinar, Wendy focused on the HHS and FDA requirements regarding the content of an informed consent form, and provided tips for making consent forms more understandable to the general study population. Questions she answers in this Q&A include:
- What is the impact of NPRM (Notice of Proposed Rulemaking) on consent forms?
- Do you have any tips for sites working with a central IRB in multi-site studies?
- What is the best way to present risks if there are multiple drugs in a study?
- What are the federal regulations on consent forms?
- Writing cost language can be very difficult. Do you have tips for simplifying it?
- Do you have any tips on consenting pediatric subjects?
Use the playlist below to navigate through each question and hear Dr. Tate’s response.