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.

Consider a more contemporary, real-life case.  A PhD from a science department at a major public university developed cancer.  His physician presented him with the opportunity to enroll in a trial of a new agent under study for approval by the Food and Drug Administration.  He took the 30-page document home with him that night.  The next morning, he and his wife returned, both having reviewed it. 

The expression on the professor’s face could best be described as exasperated.  Here is what he said: “I tried reading this thing several times, but finally I just gave up.  I am pretty smart, but I have enough to worry about with my diagnosis, and this informed consent form is so overwhelming that I simply can’t tell the difference between what is important and what is just legalese.  Would you please just tell me about the study and so we can discuss it?”

Informed consent is a relatively new term, coined in the 1950s in the courts, when patients underwent ill-advised care and suffered adverse outcomes, not knowing that other options were available or that they could have simply declined.  The idea is that patients should have the opportunity to learn about and decide whether to proceed with medical care or research that poses a risk that any reasonable person would want to know about.

The historical rationale for informed consent can be traced in part to the experiments performed by the Nazis during World War II.  In many cases, physicians conducted risky, painful, and sometimes deadly experiments on thousands of concentration camp inmates without their consent.  After the war, resulting military trials led to the Nuremberg Code, which established that medical experiments on human beings could be performed only with informed and voluntary consent.

No one would argue that research trials and medical care should be carried out without consent.  However, the current practice of informed consent has evolved so far from what was originally intended that it might better be described as a mutation.  In fact, it often resembles a monstrosity, no longer serving its primary purpose – to protect patients and research subjects – but instead now protects doctors, researchers, and institutions.

One problem is a faulty assumption that the more information is contained in the informed consent form, the more knowledgeable and therefore more protected the patient will be.  Often every conceivable benefit, risk, and alternative is addressed, as well as financial issues such as who will pay for what, intellectual property rights, privacy protections, conflicts of interest, and language designed strictly to indemnify the institution. 

Two fairly routine informed consent forms that we know run to 33 and 35 pages, respectively.  The first includes a list of 108 side effects that may occur in those taking the drug, including “abnormal blood test results,” “pain,” and “murderous thoughts.”  The second contains a chart of tests performed as part of the protocol, including 15 blood samples, 14 pregnancy tests, 9 thyroid function tests, and 4 symptom-directed physical exams.  No wonder even a PhD can’t understand it.

To repeat, the length and complexity of the forms is being driven less by protecting the patient and more by protecting the institution, should something go wrong.  Rightly or wrongly, people with oversight in such studies believe that if a problem is mentioned in advance, the probability of an unfavorable litigation outcome is reduced.  As a result, informed consent forms are as unlikely to be read and understood as are the byzantine licensing agreements that accompany software updates.

One of the most important goals of informed consent is to protect patient autonomy, but the complexity of the forms makes patients more reliant than ever on doctors, researchers, and institutions to explain the risks and benefits.  Just ask patients why they are being asked to sign the form.  In our experience, many will offer the matter-of-fact reply: “Why, of course, to protect the institution.”  In other words, patients may not understand the form, but they know that its purpose has been inverted.

The bodies that oversee informed consent, known as institutional review boards for the protection of human subjects (IRBs), continue to talk as though patient protection is the goal.  We do not doubt their sincerity.  But the complex process means that the vast majority of patients are operating strictly on trust, and the actual consent too often resembles a box-checking exercise.  If we expect patients to actually read the form, we should present them with something at least a PhD can understand.

Richard Gunderman, MD is Chancellor’s is a professor of radiology at the University of Indiana. James Lynch, MS is a professor of oncology at the University of Florida.

9 replies »

  1. Myself, a Psychologist, and an Attorney created Confirmed Consent (www.confirmedconsent.com) which provides a mechanism for the patients to get a true standardized, non-pressured informed consent, but also confirms the patient’s cognition and competency to give said consent. I think with today’s technological advancements and ever-savvy consumer, there is no reason that the informed consent process can not be improved!

  2. Its definitely a legal protection not a clinical one. Lets try to be very clear. As an orthopaedic surgeon, if I suddenly needed emergent vascular surgery, I would ask one of my vascular colleagues to help me. I would…big word here….TRUST…. the surgeon to do what s/he feels is best for my condition. I don’t need any lengthy forms describing all the potential complications, or bad outcomes. If I let all that anxiety, worry, “knowledge” about procedure/outcomes fall on the vascular doc, then its easy for me. Its asymmetric power in the relationship for a reason. Like teacher/student. Because it works that way. MANY of my patients do NOT want to hear about ALL the potential complications, nor want to read them. Many would not even understand. If you want to learn about your condition, great, but don’t become a Dr. Google and ask my why magnets cannot cure your infected total knee. Find a physician you trust and go from there.

  3. This is tough subject matter, but one of the things a lengthy informed consent document does is to limit further actions not already listed. It is sort of a stop gap measure making further informed consent decisions necessary for future unknowns.

  4. The presence of a signed consent form does not necessarily provide protection. Its absence makes you vulnerable, so informed consent, as practiced, is just another way to leave people open to suit if they forgot to get a signed form. It is process that seldom fulfills its intention. A large percentage of my patients say they don’t want to know the details and risks. Another big group ignore what i have to tell them. Another big group clearly don’t have the capacity to understand. At the very least, I think we ought to be able to ask people if they want to hear the risks and if they don’t just forego the process and forms.


  5. Drs. Gunderman and Lynch: A fine article. As a recovering lawyer, my issue with a 35 page form with prolixity would be whether any consent would in fact be “informed.” We already know that judges and juries already overturn so-called consent forms because they were procured under circumstances that vitiated voluntary and informed consent. Waiver to be fully effective must be both voluntary and informed. We’ve seen the Obama Administration regulations invalidate mandatory arbitration clauses in long term care facilities [the Trump Administration is changing that].

    Your point, however, is important: this whole dance was to protect patients. It does anything but. Thanks.

  6. We might not doubt the sincerity of IRBs but they are clearly not keeping up with their responsibility. It’s not surprising as most of our medical institutions are having trouble keeping up with the times. IRBs are not addressing the asymmetry of the power relationship in the situation. The post’s anecdote about research in concentration camps is an extreme example of asymmetry of power.

    We need to move beyond the current norm to recognize and deal with asymmetry. Practical and cost-effective access to second opinions are now essential. That starts with total access to the patient’s record, the plan, and the consent form itself via the patient-directed API in Meaningful Use Stage 3 (2015 edition). Before a patient is asked to sign a 33-page document, they need to have been told they have a right to a second opinion and they need the sign-in password to the patient portal that they can use to authorize access by anyone they choose including not just other doctors, but family caregivers, and artificial intelligence services like IBM Watson and Google Deep Mind as they come to market.

  7. The decline & fall of informed consent was engineered by the for-profit medical-industrial complex to serve industry, not patients. Medicine and research is all for-profit in the US and leads to mistrust of technology and bad treatment outcomes. See: surveillance capitalism http://www.economist.com/news/leaders/21721656-data-economy-demands-new-approach-antitrustrules-worlds-most-valuable-resource Obviously great interactional consent IT exists but it’s rarely used; why bother to treat patients like human beings if you don’t have to?

  8. Any ideas on improvement? Maybe they–informed consent efforts–should be orally delivered and audio-recorded? Or even toss in a video of the whole process…in order to better guage the patient’s understanding?