Tuesday, June 12, 2012

What is Informed Consent?


Life is full of decisions.  For most us that means weighing options and making a choice that best fits with our values and the ‘facts’ related to the decision.  Facts and values are in many respects analogous to our heart and mind or ‘what we want’ versus ‘what we know.’  The less we know before making a decision the greater the chance we will make a choice that is not consistent with the facts, our values or both.   Medical decisions are no different than any other kind of decision.  Accessing medical facts relevant to a medical decision, however, can be difficult.  Likewise understanding our values can be unclear for health states we cannot realistically imagine.  Physicians are the primary conduits of medical information for most patients facing a medical decision.  Curiously physicians are also important in helping a patient sort out their values.  Informed consent is that process whereby a physician imparts medical facts and clarifies a patient values.

Informed consent is a modern feature of western medicine.  The philosophical underpinnings of informed consent are diverse.  Clearly the principle of autonomy comes to mind but beneficence and justice are also important.  More broadly understood, informed consent draws from deontological ethics wherein physician duties to patients and society are recognized.  Simplistically informed consent reduces to disclosure, competency and choice.  Physicians as purveyors of health information have a duty to disclose to those in their care the health information necessary to ensure the patient makes an informed choice.  From an ethical perspective, competency is that state wherein the patient understands and can manipulate the disclosed health information so as to make a choice that reflects the facts of the decision and how those facts are personally valued.  Reflecting on these elements should give us all pause.  While informed consent law and litigation has focused on what is to be disclosed, the ethical principles upheld in informed consent are better captured by what the patient comprehends since this is the basis upon which choice is made.  Informed consent, therefore, is not about dumping voluminous information on the patient and letting them sort it out.

Among members of the Navajo Nation it is a common belief that to speak ill of something increases the likelihood of that adverse event happening.  In the context of informed consent this can mean to disclose treatment risks will provoke these events to occur.  This is an example of the tension between disclosure and competency.  Members of the Navajo Nation have declined clearly beneficial treatments because the informed consent disclosure was seen to induce the uncommon adverse events associated with the treatment.  If autonomy were the only principle honored in informed consent then disclosure of risks in this context would undermine beneficence.  Do such situations then warrant paternalism?  No.  What should be understood is the complex and inexorably time-consuming process of understanding the context of a disease in the life of an individual and how treatment decisions are made within that context.

Physicians often manage illnesses more so than disease.  The distinction being drawn here is that a disease references the medical facts present in a given person but an illness considers how those fact manifest in a given persons life.  Consider two women who void 15 times a day.  One woman is a rural mail carrier who comes from a very traditional American home.  The other woman is an immigrant office worker.  Access to a bathroom is vastly different between these two women.  The cultural expectations of adult life are also different.  These differences will very likely impact which of these two women will present for treatment for what is precisely the same biomedical facts.  Acknowledging the distinction being made here highlights again the need to understand the patient’s illness when rendering an informed consent.  The biomedical facts of a disease will not necessarily precipitate the necessary disclosure to ensure a patient is competent to make an informed choice regarding treatment.

There are many books and articles written on the topic of informed consent.  The topic can become overwhelming to consider and many of the issues alluded to above cannot be made formulaic yet this can be the impression of informed consent for many clinicians; just get the patient to sign the informed consent form.  Physicians have an ethical duty to construct the decisional environment necessary to allow a patient an informed choice.  This process is inevitably imperfect.  This process should inevitably call on the clinician to know treatment specifics and the patient to whom these specifics will be disclosed.  This process is a disposition for ethical care that honors the best traditions of medicine.

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