Informed consent—the idea that patients have the right to make their own decisions about their medical treatments—first appeared in court rulings in the early 20th century. It was codified into law in the 1970s and 1980s and is now sacrosanct.
“The point of informed consent is to demonstrate that the physician or the provider has given the patient all the material information they need to make an informed decision," says Jay Reyero, partner for ByrdAdatto, a Dallas-based healthcare and business law firm. “It is more than a signed consent document.”
Physicians are legally and ethically required to share with patients the nature of the recommended procedure or treatment, the potential risks and outcomes, and what to expect in the days and weeks following the treatment. In the medical aesthetics industry, treatments typically are performed on healthy patients, so physicians and practices have an added ethical obligation to ensure that patients fully understand any potential risks.
A physician who subjects a patient to a procedure the patient has not agreed to has violated that patient’s rights and may be subject to litigation, loss of medical license and loss of hospital privileges.
Here's what aesthetic practices need to know about informed consent requirements and recommendations.
The physician must provide enough information to allow the patient to make an “informed” decision about their medical care. Court rulings in the late 20th century helped clarify the information that must be disclosed. Most notably, the 1972 case Canterbury v. Spence—which was brought by a patient who was left paralyzed following a laminectomy—outlined specific information that must be provided, which includes:
- The condition being treated
- The nature and character of the proposed treatment or procedure
- Anticipated results
- Recognized alternative forms of treatment
- Recognized serious risks, complications and anticipated benefits involved in the treatment, as well as the recognized alternative forms of treatment, including nontreatment
How this information must be relayed to the patient is not legally dictated, but it typically requires a combination of verbal and written information. The medical provider must also make every effort to ensure that that the patient understands what is being discussed. “As far as disclosure, there is no legal requirement to put everything in writing,” says Reyero. "This can often be accomplished verbally.”
If there has been a verbal discussion, the patient will need to sign a form stating that the physician has provided the information needed to make a sensible decision. However, going beyond legal requirements and documenting what was discussed provides an extra layer of protection to the provider and facility.
“Nothing prevents you from putting more information than is required down on paper, and I would say that is the best-case scenario,” says Reyero. “It’s very hard to argue that someone did not disclose something to you if it is in writing on a page that the patient signed or initialed.”
Going Off Label
In the medical aesthetics industry, as in all of healthcare, physicians often utilize medications or devices in ways that are not explicitly approved by the U.S. Food and Drug Administration (FDA). This is known as “off-label” use. One might presume that informed consent takes on even greater importance when a product or procedure is used off-label. But there is no current legal requirement to disclose this information.
“There is nothing in the informed consent doctrine that specifically requires a physician to say, ‘This is an off-label use,’” says Reyero. “Off-label use means that the FDA hasn’t approved this particular drug or this particular device for this particular use. But that doesn't mean usage is inherently less safe. This is why there is no specific requirement or duty for a physician to disclose that information.”
Still, it may be a good idea to include this information when providing informed consent to patients. This added level of transparency will never hurt from a legal standpoint and can add an extra layer of transparency, especially if the disclosure would likely affect a patient’s decision to undergo the treatment or procedure. Providers should ask themselves, are these risks that a reasonable person might wish to know about before accepting treatment? If so, disclosure makes sense.
In their November 2008 paper “Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions,” published in PLoS Medicine, Michael Wilkes and Margaret Johns of the University of California, Davis argue that physicians are required to disclose off-label usage as it amounts to experimental use of a drug or device. They write, “In many ways the patient given an off-label prescription is involved in an ‘n of one’ research trial and should be required to provide informed consent.”
If a physician is conducting clinical research and wishes to use a patient as a participant, the informed consent process is vital and must be handled with the utmost care. “The FDA has a comprehensive set of requirements for informed consent with respect to clinical trials or research,” says Reyero.
These guidelines can be found on the FDA’s website under “Informed Consent for Clinical Trials.” Additional information on obtaining informed consent for clinical trials is available through the U.S. Department of Health and Human Services’ Office of Human Research Protections (www.hhs.gov/ohrp).
In general, subjects must understand the purpose of the research, the length of the trial, that they may be exposed to unknown risks, that they may not benefit from the clinical trial, what discomfort they may experience and that participation is a voluntary decision.
The trend from the early 20th century to today has been toward stricter informed consent regulations, and informed consent requirements vary from state to state. So practices and providers need to review their informed consent processes based on both federal and state regulations.
“The public and the courts have consistently pushed for more transparency in healthcare, so practices and medspas are wise to err on the side of providing more disclosures than fewer,” says Reyero. “My rule of thumb is always to disclose as much information as possible, because it can only protect you.”
Alex R. Thiersch, JD, is a healthcare attorney who represents medspas and aesthetic medical professionals. He is the founder and director of the American Med Spa Association (AmSpa) and a partner at the ByrdAdatto law firm. Contact him at firstname.lastname@example.org.
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