In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided detailed feedback in anticipation of the final guidance....
In February, FDA released a new guidance document entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”. The purpose of the guidance is to help small businesses, particularly clinical trial sponsors, investigators, and institutional review...
All of us in research are aware of the challenges with length and understandability of informed consent documents. In a new article found in the December issue of Anesthesiology News entitled “Uninformed Consent: Average Study Participant Likely Unaware of...
