Tag: Informed Consent

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.

Continue reading…

Informed Consent 2.0

Screen Shot 2014-08-14 at 2.06.08 PM

Is healthcare going to the dogs?  In at least one way, it probably should.

While not often spoken of together, physicians and veterinarians share an otherwise unique position of helping people make healthcare decisions in the awkward and charged space between risk, benefit and cost.  Both share an ethical requirement to provide the information necessary for informed decision making. Before starting a treatment or procedure, patients (and pet owners) need to understand the potential risks and benefits of their care, as well as the reasonable alternatives.

But veterinarians often share some other important information, information that physicians seldom share, or even know – that being: exactly what will it cost.

When our family dog recently became very sick, my veterinarian shared not only about the diagnosis, her recommended treatment, its risks, benefits and the plausible alternatives, but she also provided a detailed estimate of what Cosmo’s care was going to cost me.

Isn’t it crazy that when it comes to our own healthcare, we don’t get the same information?

Continue reading…

Why the WHO ethics advisory group is a start but hardly sufficient

Screen Shot 2014-08-12 at 5.37.18 PMThe much awaited WHO ethics advisory group on the use of experimental drugs to combat Ebola has issued its statement.  While a start it is no more than a baby step.

The advisory panel did decide that they found the case for using experimental drugs in African populations ethical.  While they did not say much about why they reached this conclusion it seems valid in that when facing a deadly plague the overwhelming majority of people infected would want a drug, even one that has barely been tested, to try to save themselves or a family member.  In reaching this conclusion the committee puts to rest the argument that experimental drugs could not go to Africans at all or ought to go to Americans or Europeans first in order to avoid the charge of exploitation.  In a plague that kills 90% of its African victims complaints about unwarranted exploitative research seem a bit ridiculous even against a long history of misuse and abuse of poor desperate persons in poor African nations.

The committee did not say a good deal more other than that informed consent and choice ought to be respected.  This is far less helpful.

Continue reading…