Saturday, December 10, 2011

The Problem of Consent

      Given the fact that my adult sons are both frequent participants in clinical trials which test new therapies for cystic fibrosis, I am especially interested by an article I just read in Anesthesiology News, entitled "Uninformed Consent: Average Study Participant Likely Unaware of Risks." A recent analysis of informed consent documents from 15 different clinical trials at two institutions revealed that, instead of the standard 8th grade reading level recommended by the institutional review boards (IRBs), these documents were written on an 11th grade reading level, placing the study participants at serious risk for uninformed consent, especially if the documents were being relied upon as substitutes for verbal interaction between subjects and their investigators. The implications of these findings are troubling on many levels, not the least of which is the revelation that many of our patients are signing consent forms they cannot read. Patients who decide to participate in clinical trials do so for a variety of reasons, mostly altruistic in nature. They want to help others. They hope that in helping others, they too may benefit. Perhaps most importantly for physicians and researchers, they trust us, and we owe them some face time.
     Bioethics is largely a convention of the mid-20th century, arising from the aftermath of human atrocities committed by Nazi death camp doctors, along with the infamous Tuskegee experiment, in which physicians knowingly administered sham treatment, instead of penicillin, to black sharecroppers with syphilis. The Nuremberg Code, which was developed following the Nazi war criminal trials in 1948, provided an initial framework of principles concerning the voluntary consent of subjects participating in human experimentation. In 1964, the Helsinki Declaration further expanded upon these principles, and is widely regarded as the genesis of today's informed consent procedure. Not surprisingly, these developments were of great interest to both clinical and research anesthesiologists. Henry Knowles Beecher, an anesthesiologist and innovator in the nascent field of bioethics, published "Ethics and Clinical Trials" in 1966.  In this paper, he publicly exposed medical research in which investigators had violated fundamental standards of informed consent, sounding the alarm on unethical human experimentation in American medicine. He introduced the concept that a patient's welfare superseded any real or perceived scientific value of a clinical trial. His bold examination of the conflict of interest inherent in physicians acting as clinical investigators provided impetus for the formation of peer-supervised committees (IRBs), charged with monitoring biomedical and behavioral research involving humans, and protecting the rights and welfare of the subjects of experimentation. In 1974, the U.S. Congress created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, culminating in the 1979 Belmont Report, a treatise on the ethical principles underlying research on human subjects. This report invoked the ethical principles of patient autonomy, beneficence, and justice, and identified their application to modern research practices. Clearly, these principles and guidelines have utility not only in research, but in clinical medicine as well, especially with regard to the informed consent of patients undergoing surgical procedures.
     As an anesthesiologist, I've had plenty of pre-operative conversations with patients who tell me, "Doc, I don't really want to know any details. Just do what you've gotta do, and make sure you wake me up." I find these patients particularly frustrating. How is it possible that someone can entrust me with his or her life, and not want to know every single detail about what I will be doing to them after they are "asleep"? By trusting us implicitly, yet foregoing a dialogue concerning the risks and benefits of their anesthesics and procedures, our patients are volunteering to be short-changed. In succumbing to fear or ignorance, patients who "don't want to know" are unknowingly surrendering their autonomy, and we simply cannot permit this. We are morally obligated to translate the lessons of the past into everyday practice, and to safeguard our patients' human rights.
     A former colleague of mine has a wonderful way of circumventing the dilemma of the uninformed patient. She doesn't give her patients that choice! She's a vivacious woman of Jamaican descent with a pronounced Brooklyn accent, who found it necessary to develop a risk-benefit-option "spiel" because of the fact that her institution lacked a separate consent for anesthesia. A strong patient rights advocate, she found this unacceptable. "We have to say something!" she laughingly recalled during a recent phone conversation, during which we discussed the topic of informed consent. Her spiel goes something like this (you have to imagine her enthusiastic, rapid-fire speech, and of course, the Brooklyn accent): "Okay! Now, we're going to talk about your risks from anesthesia. They are highly unlikely, but they include damage to your teeth, lips, eyes, and nose, damage to the nerves in your arms and legs, problems with obtaining or maintaining your airway, and unforeseen potentially catastrophic events. We are going to take great care of you! Are there any questions?" In this short, but concise monologue, she alerts her patients about what they are getting into, conveying the serious nature of the risks inherent in the anesthetic, while simultaneously reassuring them that every effort will be taken to minimize those risks. In opening up the floor for questions, she gives her patients the opportunity to exercise their autonomy.
     We, as physicians and investigators, are the ones ultimately responsible for ensuring that our patients understand what we are doing to them, why we are doing it, and what will happen if we don't. In doing so, we empower them to make their own decisions about the treatment they are willing to accept. When our patients don't seem interested in learning, ensuring that they are adequately informed becomes a challenge. This is where we have to rely on creativity born of necessity, just like my resourceful colleague, and find a way around the problem of consent.

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