At the 42d meeting of the American Society of Nephrology in San Diego this week, entitled “Renal Week,” Elisa J. Gordon, PhD, MPH, of Northwestern University presented a study on informed consent, that found that “kidney transplant consent forms are written at considerably higher reading levels than they should be.”
She is of the view that consent forms should be written at a 5th to 8th grade reading to ensure that transplant candidates are well informed about transplantation processes, understand the material, and can provide informed consent.
My concern is that many physicians see forms as a satisfactory replacement for actually sitting down with a patient and explaining, not only generalized information regarding kidney transplants but also the specific and unique condition, risks and prognosis for each patient.
Physicians must not labor under the impression that a form satisfies their legal and ethical obligations for a real consent based upon all material information. If the question of informed consent is ever raised in a legal setting that form will not solely provide evidence of an actual informed consent.
This process should not be delegated to a medical assistant to “get the form signed.” The format and language used should, as Dr Gordon stresses, be assessable by all. Care however must also be taken to document the informed consent process and an explanation provided of the ability and level of understanding the patient or his or her surrogate decision maker.