The concept of medical informed consent is evident already in the Hippocratic Oath, which clearly illustrates the notion that respect is an integral part of the relationship between patients and health care professionals in the pledge, "First, do no harm."

Although the theory behind informed consent has changed through the years, two different aspects need to be recognized and separated—one pertaining to research, the other to therapeutic intervention.

Unfortunately, medical experiments on human subjects have been performed for centuries without consent and without respect for the autonomy of patients. Two well-known examples from the history of medicine come to mind. One was the testing of smallpox vaccine in 1796 on the young James Phipps by Dr. Edward Jenner. The other was the 1899 experiment by Dr. Walter Reed on Army personnel and other volunteers who were encouraged to live and sleep in clothes and blankets previously used by people who had died of yellow fever. This last experiment was performed to test the theory that yellow fever might be transmitted by fomites.

During the 20th century, numerous experiments were conducted on soldiers and civilians without their consent, not for the purpose of directly helping people, but to test different medical hypotheses.¹ A groundswell of support for prohibiting all nontherapeutic research without consent eventually resulted in the Belmont Report from the National Commission For the Protection of Human Subjects of Biomedical and Behavior Research.² This report outlined the ethical principles related to human testing and introduced an informed consent process that provided the blueprint for the informed consent used for therapeutic interventions today.

A landmark legal ruling in 1914 emphasized not only the autonomy of the patient but also the importance of considering patients’ wishes.³ The judge in this case ruled that "every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages."

From this, and later from another case in 1972,⁴ the "professional standard" and the "reasonable person standard" were developed. These standards—which may vary from one jurisdiction to another—established that the amount of information given to a patient should be the same as any other competent health care professional would have disclosed, and that the information should be in sufficient detail that it could be understood by a reasonable person.

Thus, from a legal perspective, there are three components that need to be addressed in the informed consent process for therapeutic interventions:

– explanation of a procedure in such a way that a competent adult patient will understand it;

– explanation and assessment of risks and benefits of the procedure, or the consequences if no procedure is performed;

– discussion of alternative interventions.

There also is the moral duty not to act against a patient’s will. A patient should not be coerced into, unduly influenced to, receive inducements to or be intimidated into having a procedure.

There is no question that using informed consent for procedures is morally, ethically and legally the right thing to do, but there are several inherent problems that need to be addressed to truly achieve an informed consent.

Recently, the emerging problem of bisphosphonate osteonecrosis (BON) has been recognized and discussed in both the professional literature and the lay press. New information and statistical data are reported weekly. How would it be possible for a dentist, on any given day, to give a patient the most updated and necessary information for an informed consent for this particular potential complication?

One solution to this problem is for professional organizations to start promulgating timely updates on this and similar emerging issues to establish a professional standard. The American Dental Association is doing just that in this issue of JADA; on page 1144, the ADA Council on Scientific Affairs reports on an expert panel’s recommendations for the dental management of the care of patients receiving oral bisphosphonate therapy.⁵

So that an informed consent is more than a reflection of the dentist’s perception of risks and benefits, it needs to be recognized that a patient’s ability to make choices is based on his or her values, preferences, experiences and knowledge. Should the process of obtaining informed consent then be based solely on the patient’s decision, with the dentist playing a neutral role? Or should it be a shared decision?

Theoretically, the patient should be given all the information necessary to make an autonomous decision, including a risk:benefit analysis. But is it really possible to illustrate dire complications of therapeutic interventions through the rendering of mathematical odds ratios and frequency of occurrences without inserting such variables as the expertise and skill of the treating health care professional?

As any experienced dentist can attest, when the outcome of a procedure involves disfigurement or high risks of complications, more often than not the patient will rely on the recommendation of the practitioner. And why not? Patients generally choose health care providers they trust. Unfortunately, some patients exhibit an unquestioning attitude toward those in authority. In such instances, an informed consent may be little more than the actual act of signing a document.

It is important to realize that it is not the written word but the interaction between dentist and patient that is the foundation of informed consent. The process of obtaining informed consent should not be looked on as a legal necessity and a duty, but rather as a virtue of good dental practice.