MedEsthetics magazines offers business education and in-depth coverage of the latest noninvasive cosmetic procedures for physicians and practice managers working in the medical aesthetics industry.
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LEGAL ISSUES | By Padraic B. Deighan, JD, PhD Informed Consent The informed consent process involves more than just sharing risks. Informed consent is the process by which a treating health- care provider discloses appropriate information to a patient in order for the patient to make a voluntary choice whether to accept or refuse the proposed treatment. It originates from the legal and ethical rights of the patient to direct what happens to his or her body as well as from the ethical duty of the physician to involve the patient in the healthcare decision-making process. The most important goal of informed consent is to make sure that the patient is given an opportunity to act as an informed participant in his or her healthcare decisions. It is generally accepted that informed consent includes a discus- sion of the following elements: • The nature of the procedure and expected outcomes; • Reasonable alternatives to the proposed procedure; • The relevant risks, benefi ts and uncertainties related to each procedure; • An assessment of the patient's understanding of the above elements; • The patient's acceptance of the intervention. If the recommended procedure involves an "off-label" use of a product or device, the informed consent must include a disclosure that the product is being used in an off-label man- ner and that the patient understands what the term means (i.e., this is a non-FDA-approved indication). In order for the patient's consent to be valid, he or she must be legally and mentally competent to make the decision, and the consent must be voluntary. It is true that most aesthetic physicians are not psychiatrists or psycholo- gists; however, objective and prudent judgment should always be utilized and maintained throughout the decision- making process. It is easy for inherently coercive situations to arise in aesthetic medicine. Patients are often in a position of vulner- ability: They do not know the relevant risks versus potential rewards of a particular procedure. A friend who advised them that the surgeon and procedure yielded wonder- ful results may have referred the patient, meaning that the patient has entered the practice with unrealistic expecta- tions. The patient may have body dysmorphic disorder or other emotional or mental conditions that make informed consent a challenging proposition. These patients are considered vulnerable because the overwhelming desire for self-improvement outweighs their own personal judgment. Therefore, the physician must act as gatekeeper, screening such patients. (In these cases, the decision not to treat a particular patient may be a prudent one.) EDUCATING THE PATIENT When presenting information in the informed consent form, the physician should make clear to the patient that they are participating in a decision-making process and not merely signing a necessary form as a matter of procedure. The process should be viewed as an invitation for the patient to ask questions and actively participate in his or her medical aesthetic care. 34 SEPTEMBER 2014 | Med Esthetics © GETTY IMAGES