Putting the Informed into Informed Consent
Physicians and clinical trial coordinators often view “informed consent” as just a form that needs to be filled out or a procedure that needs to be undertaken. A common consequence is that those who have consented have not necessarily been well informed. Informed consent should really be treated as an ongoing process, with a chance for patients to absorb and discuss information over time.
A new study of informed consent for clinical trials conducted in the ICU comes to the not very surprising finding that most patients who consented to participation in a trial don’t really know what’s going on. I would have been shocked if the data showed anything else.
A more useful study, in my view, would examine how many patients undergoing elective procedures or enrolling in clinical trials outside of the hospital understand what is happening.December 8, 2006