In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided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....
After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects. The guidance begins by reiterating the basic process for obtaining consent, beyond written documentation. FDA...
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...
