Tag: Clinical Trial

The Decline and Fall of Informed Consent

Richard Gunderman

Margaret Edson’s 1999 Pulitzer Prize winning play, Wit, tells the story of the final hours of Vivian Bearing, PhD, an English professor dying of cancer.  Early in the course of her disease, one of her doctors sees the value of her case from a research point of view and asks her to enroll in a clinical trial of an investigational therapy.  In the film version of the play, which stars Emma Thompson, he hands her a two-page informed consent form to sign. 

Wit deals with many timeless features of terminal illness, death, the care of the dying, and the meaning of life, but this aspect of it strikes many contemporary physicians and medical researchers as extraordinarily quaint.  Informed consent remains an integral part of medicine, but the sight of an informed consent form that runs to only two pages – particularly one for an investigational cancer treatment protocol – seems nearly laughable.

Each year, millions of patients and research subjects are asked to sign informed consent forms.  Situations where informed consent should be obtained include blood transfusions, surgical procedures, and participation in clinical research trials, among many others.  The situation is familiar to many – the doctor walks in bearing a clipboard, explains the procedure, and asks the patient and a witness to sign on the bottom line.  The only problem: it is often neither informed nor a real consent.

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