FDA Additions to Informed Consent – Will they help improve participant engagement?

Paul Ivsin, our colleague at Continuum Clinical, a Spectrum Science company, delves into the ongoing challenge of making informed consent forms (ICFs) in clinical trials more patient-friendly. His latest blog highlights how excessively long and complex IFCs are, and the FDA’s response to actually expand them further, adding a new Key Information section intended to provide a summary of essential points at the beginning of the document. While this section may resemble an executive summary, there are concerns that it could merely compound the issue by adding more content to an already lengthy document.

Read the full blog here, to gain insight on the potential benefits of this Key Information section, and what you can do to ensure a positive clinical trials experience for all stakeholders.