Attending to the Patient in the Informed Consent Process

An interesting article titled “Personalized Disclosure by Information-on-Demand: Attending to Patients’ Needs in the Informed Consent Process” written by Gil Siegal, Richard J. Bonnie, and Paul S. Appelbaum appears in the Summer 2012 issue of the The Journal of Law, Medicine & Ethics (vol. 40, issue 2, pages 359-367).

A discussion is made of the current informed consent process and how it is the foundation of medical ethics and health law. Now is clear from the complications page of my website, I have numerous problems with the informed consent process.

In the article the authors state

“The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians — to respect and facilitate patient autonomy — is reflected in the rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.”

The issue in the process is that physicians have the information patients need to make educated decisions whereas patients generally do not have access to this information. Hence some states in the U.S. have adopted the “reasonable patient” standard whereas others have adopted the “reasonable physician” standard. I have some good information on this in a post titled the Well Informed Patient.

The authors in the article go on to state

“Most agree that the commonplace ritual of informed consent — focused as it is on the presentation and signing of a consent form — has many flaws. Viewed from the patient’s perspective, what should be an iterative, personalized process of receiving and absorbing information and seeking clarification or further information has become standardized and inflexible, as physicians attempt to comply with a duty to inform all patients in a generic, “reasonable” manner.”

The authors propose an alternative to informed consent and shifting the control of the informational process to patients. The authors state

“This approach rests on recognition that people differ in their level of risk aversion, inclination to immerse themselves in medical information, medical literacy, feelings of self-efficacy, and desire to rely on others to make important decisions…”

The authors go on to describe a two stage process. Stage 1 is the transition step where patients signal their desire for information. Stage 2 is the fully individualized disclosure where interactive software plays a large role.

The authors use an example in stage 2 as

“…once a physician has proposed a particular course of treatment to the patient and has explained the rationale for doing so in general terms, the physician might provide the patient with a CD, flash drive, or the link to an Internet website that includes particularized information.”

The authors conclude by saying

“Our modest aim is to lay down a new paradigm of information on demand, designed to empower patients, enhance legal certainty, and achieve greater congruence between the information patients want and the information they receive. It is possible that this approach could also promote more meaningful patient-physician interactions in many cases, a desirable outcome that has been difficult to achieve by other means.”

I skipped over many parts of the article and just highlighted what I thought was interesting above. Clearly this approach has many skeptics and it can be difficult to convince those in the medical and legal fields to change.

Personally for me my concern with informed consent even with changing to a process as described in the article is the lack of information about the likelihood to receive compensation if you become injured from the treatment. I deem this as material and highly relevant to the decision.

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