On a busy day in the office, with back-to-back patients, it can be easy to skip past all the formalities of treating a patient, like consent forms.
But on the legal side, AND for optimal patient care, performing a treatment without informed consent can get you in hot water. In many – if not all – malpractice suits, one of the primary elements of the complaint indicates a lack of informed consent prior to treatment. Basically, plaintiffs claim that they do not fully understand the risks of undergoing a given treatment and alternative options, including the option to do nothing (as well as risks of doing nothing).
So make sure your patients are fully informed and that you have a documentation to back it up. But what constitutes “informed consent”?
Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment. It originates from the legal and ethical right the patient has to direct what happens to their body and from the ethical duty of the physician to involve the patient in their health care.
Informed consent is typically not considered to be adequately obtained unless all seven of these elements have been met by the patient or their legal guardian/representative:
- The patient must be competent to understand what is presented.
- The patient must voluntarily make the decision, not under any kind of coercion.
- Material information – that which is essential to making a wise decision – must be fully disclosed.
- The plan for treatment must be clear.
- The patient must adequately comprehend material information and the plan.
- The patient must clearly make a decision to proceed with the plan.
- The treatment plan must be authorized by the patient.
Informed refusal occurs only when elements 1-5 have been met, but the patient opts not to accept the plan.
To make sure all of your bases are covered, what should your office include in any form for consent?
The most important goal of informed consent is that the patient has an opportunity to be an informed participant in their health care decisions. It is generally accepted that informed consent includes a discussion of the following elements:
- The nature of the decision/procedure
- Reasonable alternatives to the proposed intervention
- The relevant risks, benefits, and uncertainties related to each alternative
- Assessment of patient understanding
- The acceptance of the intervention by the patient
In order for the patient’s consent to be valid, they must be considered competent to make the decision at hand and their consent must be voluntary. To encourage voluntariness, the physician can make clear to the patient that they are participating in a decision-making process, not merely signing a form. With this understanding, the informed consent process should be seen as an invitation for the patient to participate in health care decisions. The physician is also generally obligated to provide a recommendation and share their reasoning process with the patient. Comprehension on the part of the patient is equally as important as the information provided. Consequently, the discussion should be carried on in layperson’s terms and the patient’s understanding should be assessed along the way.
Basic or simple consent entails letting the patient know what you would like to do; giving basic information about the procedure; and ensuring that the patient consents to the treatment. Sometimes consent to the procedure is implied (e.g. the patient came in to have a root canal), but an explanation of the elements of the procedure remain necessary.
While it is tempting for dentists to assume that they are obtaining informed consent when they have patients read a form and sign it to acknowledge understanding, signed forms only represent an attempt to inform the patient. Forms do not replace active discussion!
Your conversation with your patient about their consent is an integral part, mainly because a lot of the people don’t read! Make sure your patient understands the risks and complications, even though you don’t anticipate any occurring. So, couple giving the consent form with a really solid patient-doctor conversation.
I’m sharing with you the consent form that I created for my practice, that you can download and personalize as you see fit. You may find shorter forms, but it was important to me to be thorough with this version. Plus, if you’re talking through the options with your patient, following the points on the form leads to a truly informed decision on behalf of your patient.
Thank you to Spear Education and University of Washington School of Medicine for their articles that helped me express the legal side of informed consent. Their content is quoted here, and you can reference the original articles by clicking their names.