Quality Resource Guide l Informed Consent in the Dental Setting 1st Edition 2 www.metdental.com Introduction • What is meant by informed consent? • How much information do you have to give to a patient to obtain informed consent? • Do I need to have all this in writing to have informed consent? These are just some of the many questions that oral health care professionals have regarding the use of informed consent procedures. Legal background In almost every malpractice suit against a dentist, there appears an allegation that the dentist failed to get informed consent. The need for informed consent falls under the power of each state in the United States to look out for the health and well- being of its’ citizens. Given we follow the English legal system, informed consent either develops through case law or via legislation. It is essential to understand how this concept developed to understand informed consent today. A key early case dealt with a passenger on a ship required to receive a vaccine to enter the United States. In O’Brien v. Cunard Steamship Co., (154 Mass. 272, 28 N.E. 266 (1891), a passenger claimed the steamship and its doctor committed an assault by forcing her to receive a vaccine before being allowed to enter the United States. The court looked at the passenger’s behavior to determine whether she consented, no matter what her unexpressed feelings may have been. Noting that the passenger stood in line with two hundred other passengers, heard their conversations, saw the surgeon giving vaccines to others, held up her arm to be vaccinated and never voiced an objection to it, the court ruled there was valid implied consent to receive the vaccine. The landmark case involving informed consent came from New York in Schloendorff v. Society of New York Hospital (211 N.Y. 125, 105 N.E. 92 (1914)). A patient presented with a growth in her abdomen, which her physician diagnosed as a fibroid tumor. The physician proposed to explore her abdomen surgically, and the patient agreed, with the caveat that the physician can examine but cannot remove anything. The doctor did the surgery, discovered the growth to be malignant and removed it. The patient claimed she never consented to the removal. Justice Cardozo stated: “(e)very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages”. Thus was born the doctrine of informed consent. Definition of informed consent Informed consent is the process by which a dentist communicates adequate information to a patient so they can decide whether to accept and move forward with treatment or refuse such treatment. The duty to involve the patient in treatment decisions is both legal and ethical. The dentist must fully educate the patient on the foreseeable risks, benefits and treatment alternatives, including no treatment. This means having patients sign a consent form alone does not satisfy the requirements of obtaining informed consent. As stated, it is a process that requires a series of actions or steps to be taken to achieve a specific end; obtaining consent to treatment. What is needed to obtain informed consent to treat? In Canterbury v. Spence (464 F.2d 772 (D.C. Cir. 1972), an appeals court ruled it was not enough that a patient stated or implied they consented to treatment, consent needed to be “informed” to be valid. This decision placed an affirmative duty on doctors to engage in a process and explain to patients: 1. The risks and benefits of the recommended treatment. 2. The anticipated prognosis if treatment is accepted. 3. Alternatives to the recommended treatment, including no treatment, and their associated risks and benefits. Note that for consent to be “informed”, the patient must understand what is being explained to them; therefore, it must be in a language they understand, in terms they can understand and they must have the opportunity to ask questions. Finally, there cannot be any coercion or force applied to the patient to accept the recommended treatment. How much information must be given to a patient? This has been a question for many courts and has created some confusion. The confusion arises because different jurisdictions look at it from different perspectives: 1. Is it what the reasonable dentist would disclose to a patient in the same or similar circumstances, or is it what other dentists in the community would disclose? 2. Is it what the reasonable patient would want to know in the same or similar circumstances, or is it what this patient would want to know? Given the above, it should be no surprise that two different standards have evolved in the states: the reasonable person standard and the professional community standard. Under the reasonable person standard, dentists must reveal what a reasonable dentist would reveal given the circumstances; the material risks. A risk is material when a reasonable person, from what the dentist knows or should know to be the patient’s position, would likely attach significance to the risk when deciding whether to proceed with the recommended treatment. From the patient’s perspective, the question is whether the information is sufficient for a reasonable person to make an intelligent decision.