Califf, Sherman Contributed To Report Pushing Alternative Informed Consent Policies

President Obama's pick for FDA commissioner, Robert Califf, and a former FDA medical policy director who sources say is returning as a deputy commissioner, Rachel Sherman, both contributed to a report raising concerns that FDA informed consent requirements could deter or delay low-risk pragmatic clinical trials. The report recommends the agency apply a risk-based policy for obtaining informed consent in such trials that would permit alternatives to current requirements. Califf has since removed his name as one of the authors...