What is informed consent? According to the Merriam-Webster’s Medical Dictionary, informed consent is a noun which means “consent to surgery by a patient or to participation in a medical experiment by a subject after achieving an understanding of what is involved.”[2] Vital to this understanding is that the patient is supplied with the necessary facts but also fully capable to understand these facts. In other words, the patient needs to be mentally competent. This brings about legal ramifications which, of course, cloud the issue. When there is an absence of informed consent, ethical issues arise. Legally, certain procedures cannot be allowed to happen. If the patient is unable to give informed consent him or herself, for example in the case of a mentally incompetent patient or a child, then someone else is usually in a position to give consent. [3]

The American Medical Association (AMA) defines informed consent slightly differently on their website, which has a banner saying “Helping Doctors Help Patients.” They say “Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.”[4] The AMA implores Doctors on its website to focus on the communication process and also to document it as well. The AMA provides steps for proper communication with a patient, saying at the end of this list, “this communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states.”[5] According to the AMA, the legal ramifications of informed consent are recent, although the ethical guidelines have been understood for a long time. Informed consent as such only began appearing on the legal scene in the 1950’s, before that it was lumped into the tort law category of battery. The emphasis placed on informed consent by the AMA is not only to protect the doctor legally, but also to protect the rights of the patients.[6]

The National Cancer Institute describes two key elements for informed consent in the case of a clinical trial: the document and the process. The document is what the participant actually signs and lists a summary of the clinical trial – “including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.”[7] – and also the rights of the participant. The National Cancer Institute says that the process of informed consent is ongoing and begins long before the trial begins and end after the trial is over. “Thus, informed consent is an ongoing, interactive process, rather than a one-time information session.”[8] I think that this definition of informed consent is vital also to doctor-patient relationships as well and should not be limited to clinical trials.

The question of mental competency plays a major factor in this discussion. When is ok for a doctor to question the mental competency of a patient and at what point does the family of the patient begin to question their mental competency? The University of Washington School of Medicine advises that a patient’s mental competency is generally clear. In the cases when competency is unclear, they provide the following suggestions for assessment of the situation. Is the patient able to:

* understand his or her situation,

* understand the risks associated with the decision at hand, and

* communicate a decision based on that understanding?[9]

If it is hard to assess the patient’s competency, it is possible that the doctor will bring in a psychological consult. Often making the discernment of mental competency difficult is that some patients move in and out of competency based on medication and also disease. Doctors are encouraged, in these situations, to try and include the patient in the decision making process when the patient is lucid.[10]

It is important for the both the patient and the doctor to realize that if the patient refuses treatment, this is not necessarily an indication that the patient is mentally incompetent.[11] The patient has the right to say no. I think that many legal struggles over mental competency stem from a differing opinion between the patient and the family as to the course of treatment.

To summarize a definition of informed consent let us look to a listing of the following elements which are necessary for a complete definition of informed consent: