Written Informed Consent – It’s More Than Just a Piece of Paper
by Boyd W. Shepherd, D.D.S., J.D.
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 doctor that results in the patient's authorization or agreement to undergo a specific procedure, treatment, or intervention.
In my experience in reviewing and defending cases of State Board complaints against dentists in Texas, it is common to find that the practice and legal requirement of obtaining informed consent is often deficiently reduced to patients signing lengthy forms that they have not read or may not understand, and that were not adequately discussed, if at all. Have these patients participated in an informed consent discussion before signing a document that states that they understand the risks and alternatives to a significant dental procedure? Has the process of obtaining informed consent become merely another procedural step to “CYA” with no concern for the patient’s rights? Is not the goal of obtaining informed consent to make an effort to have the patient understand the proposed procedure or treatment plan, and the relevant possible alternatives, so that they are active participants in their health care decision making?
Generally speaking, and although we strive to teach the ethical doctrine, importance, and legal necessity of patient autonomy and informed consent at UTSD Houston, most dental students do not take specific classes on how to discuss informed consent - that is, the process of talking about the risks and benefits of a dental procedure with a patient. Most dentists may remember their first attempts at such conversations in dental school or practice, lumbering through each informed consent form, picking up certain phrases and dropping others through a sometimes painful and often awkward process of trial and error. Because they are expected to already “know what to do,” young dentists rarely have a formal mentorship or the opportunity to observe more experienced doctors doing the process well before they begin to obtain consents on their own. To improve the skill, perhaps a single day-long session could be implemented improve a doctor’s ability to navigate through the informed consent discussion, and thereby helping to properly educate countless patients and also manage risk for dentists over the course of their careers.
This communications process is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states. Providing the patient relevant information has long been a healthcare provider's ethical obligation, but the legal concept of informed consent itself is relatively recent. The first case defining informed consent appeared in the late 1950's. Earlier consent cases were based in the tort of battery, under which liability is imposed for unpermitted touching. Though battery claims occasionally occur when treatment is provided without consent, most consent cases generally center around whether the consent was "informed", i.e., whether the patient was given sufficient information to make a decision regarding his or her body and health care. Because informed consent claims, unlike battery claims, are based in negligence, they generally are covered by liability insurance.
Statutorily for the purposes of licensure compliance, written informed consent is required by Rule 108.7(6) of the Texas State Board Rules and Regulations, which states “Each dentist licensed by the State Board of Dental Examiners and practicing in Texas… (6) Should maintain a written informed consent signed by the patient, or a parent or legal guardian of the patient if the patient is a minor, or a legal guardian of the patient if the patient has been adjudicated incompetent to manage the patient's personal affairs. Such consent is required for all treatment plans and procedures where a reasonable possibility of complications from the treatment planned or a procedure exists, and such consent should disclose risks or hazards that could influence a reasonable person in making a decision to give or withhold consent.” Further, the documentation of informed consent in the patient record is required under Rule 108.8(8) of the Texas State Board Rules and Regulations, which states “(b) A Texas dental licensee practicing dentistry in Texas shall make, maintain, and keep adequate records.... Records must include documentation of the following… (8) Written informed consent that meets the provisions of §108.7(6) of this title.”
Informed consent is a process of educating a patient about a proposed procedure's risks, benefits, and alternatives. The dentist is responsible for fully educating the patient about the proposed procedure and discussing the risks, benefits, and alternatives. The patient then has the responsibility of weighing the information and making an informed decision. Once discussed and all questions have been answered, and although not legally required in Texas, the treating dentist (not an auxiliary employee) should sign in addition to obtaining the patient's signature on the consent form as evidence that the consent form was discussed by the treating doctor with the patient.
The process of obtaining informed consent that encompasses the following four elements: discussion, consent form, documentation, and educational materials.
Given that informed consent is an extension of good communication techniques and helps establish doctor/patient rapport, the discussion with the patient is the most important element. Ethically speaking, patients have a right to information and to participate in the decisions affecting their health.
The consent form provides written information to help the patient remember the risks, benefits, and alternatives you have discussed. It is a good preventive measure to give the patient a copy of the consent and retain one copy in the chart. The consent form should include the same elements as the consent discussion, and should be written in easily comprehendible lay language. As stated above, it should be signed by you and the patient. Obtaining the patient's signature should not be delegated to your assistant, because you are the licensed professional with the knowledge and skill necessary to give the adequate level of information necessary to obtain informed consent. Legally, a witness is neither required nor necessary.
Under the “doctrine of informed refusal,” and the dentist has the responsibility to inform the patients of potentially detrimental outcomes. It is wise from a claims-prevention standpoint to incorporate this element into your informed consent discussion. If the patient refuses your recommendation, explain the possible adverse outcome. This conversation should be documented in the chart and if possible the patient should sign an informed refusal statement.
It is recommended that, in addition to the consent form itself, you write a brief note in the patient's chart progress notes to document that a consent discussion occurred and the patient agreed to proceed with the treatment. If you gave the patient any handouts or instructions, document this action. Place the signed informed consent form in the patient's chart.
Example: Advised the patient of need for oral surgery extraction of tooth #30; discussed risks, benefits, and alternatives. Gave XYZ handout explaining the procedure and post-op instructions . Patient stated he/she understood, signed consent, and agreed to proceed.
Studies show that patients remember approximately 30 percent of verbal information. Educational pamphlets, written handouts, and pre- and post- instructions help the patient make an informed decision and remember what he or she has consented to if complications occur.
What should be communicated and documented?
In the communications process, you, as the doctor providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient:
How do you know when you have said enough about a certain decision? In the state of Texas, we use the "reasonable patient standard" (see bolded text of Board Rule 108.7(6), above): what would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a patient would need to know in order to understand the decision at hand. The best approach to the question of how much information is enough is one that meets both your professional obligation to provide the best care and respects the patient as a person with the right to a voice in health care decisions.