July 2, 2019
By Clarke D. Newman, OD, FAAO, FBCLA, FSLS, FNAP
Controlling everything we do as doctors of optometry and everything our colleagues in allopathic and osteopathic medicine do is a legal and ethical framework called the Doctrine of Informed Consent. To speak to a patient or a parent about this doctrine without sounding like a lawyer, we must first understand the underlying history, ethical theory and case law.
Prior to the 1950s, doctors and patients adhered to a paternalism that relied on the doctor to make decisions for the patient based on the doctor’s superior knowledge and authority and an abdication of agency on the part of the patient in service to that authority. The widely held view at the time was that patients were incompetent to make medical decisions on their own behalf, and were, thus, unworthy of personal agency in medical decision-making.1
Throughout history, examples abound. Benjamin Rush in the 1780s advised physicians to “yield to patients in matters of little consequence, but maintain an inflexible authority over them in matters that are essential to life.” Thomas Percival in 1803 advocated informing a patient only so that he or she might understand what the doctor was doing and why he was doing it; the doctor was always in charge.2, 3
In the middle of the 20th century, however, medical case law and medical ethics scholarship converged to create a new paradigm: the Doctrine of Informed Consent. In modern medicine, we adhere to the Doctrine of Informed Consent for both ethical and legal reasons. Regardless of the reason, it is important to understand that, with few exceptions, informed consent is a right.
The Doctrine of Informed Consent finds its origins in the Nuremberg Code after World War II. This code was established to prevent a repeat of unethical and immoral medical experiments on human subjects that were carried out by the Third Reich during the Holocaust.1 So, the beginnings of this doctrine were found in standards for research. Slowly, the doctrine bled over into patient care. The controlling cases are Canterbury v. Spence (1972) and Nixdorf v. Hicken (1980). These cases became the case law that defined the elements of a proper informed consent.4, 5, 6
Essentially, the case law lays out that “…the standard measuring [physician] performance…is conduct which is reasonable under the circumstances,” but which includes the following points:
(1) the condition being treated
(2) the nature and character of the proposed treatment or surgical procedure
(3) the anticipated results
(4) the recognized possible alternative forms of treatment, including non-treatment
(5) the recognized serious possible risks, complications and anticipated benefits involved in the treatment or surgical procedure.4, 5, 6
In Gates v. Jensen (1979), the Washington state Supreme Court held that a physician had to disclose any provider financial interest in whatever treatment options were on offer.7 Finally, in Truman v. Thomas (1980), the California Supreme Court held that the treating doctor had to disclose his or her level of experience with the prescribed treatments.8 This holding only applies in California. In Johnson v. Kokemoor (1996), the Wisconsin Supreme Court also held that, when reasonable, a doctor has a duty to disclose certain personal information under certain circumstances.9
With the case law in hand, the U.S. Department of Health and Human Services (HHS) promulgated rules for Informed Consent for Hospitals, and the office-based medical community has adopted those guidelines.10
Essentially, the patient, or the designated agent, which, for a minor child, is de facto the guardian parent, must be informed of the elements required by the case law. It is important for doctors to check with their respective states for state-specific requirements, like the Truman requirement in California.
To paraphrase Albert Einstein, everything should be made as simple as possible, but no simpler.11 So it is with informed consent. The best way to have a good conversation with a patient or agent regarding informed consent is to ensure that there is a document to sign that is complete, short and free from legal jargon.
Here are the elements needed for a proper informed consent:
1) Provider demographics
2) Short title of the test, procedure, service or device to be performed
3) Detailed description of the same
4) Benefits of the same
5) Risks of the same
6) Alternatives
7) Notice of U.S.Food and Drug Administration (FDA) Off-Label Use, when applicable.12
The provider demographics should contain the name, address and identifying numbers, like an NPI, of the provider performing or delivering the test, procedure, service or device. The short title should contain the CPT or HCPCS Code associated with the test, procedure, service or device. The detailed description should be just that—detailed, but in language a layperson can comprehend. The benefits of the test, procedure, service or device being rendered should be described clearly and dispassionately, but not embellished so as to put one’s finger on the scale. Do the same with the risks and alternatives.12
It is important to disclaim each of these elements by saying something to this effect: “The alternatives to atropine include, but are not limited to…” You need to admit that the disclosure might not be an exhaustive list. It is also helpful to explain each element of the benefits, risks and alternatives in bullet-point lists. This method is a clear and easy-to-understand method of communication.12
Currently, myopia control is not an FDA-approved indication for spectacles, contact lenses or medication. Therefore, it is important to disclose that treatments aimed at reducing the progression of myopia are not approved by the FDA.
If you have an informed-consent document written in language that anyone can understand and that contains the elements of informed consent required by law and standard, then you have the playbook for discussing the various issues surrounding myopia control. Follow the script of your consent document so you do not forget anything, and you or your staff should discuss these elements with the parent. Never just hand a consent document to a parent. Follow these steps, and you will be a doctor doing your duty to inform and not sounding like a lawyer.
Endnotes
1 Murray, B: “Informed Consent: What Must a Physician Disclose to a Patient?” American Medical Association Journal of Ethics July 2012, Volume 14, Number 7: 563-566.
2 “Informed Consent: I. History of Informed Consent,” Encyclopedia of Bioethics, 2004, p. 323.
3 Percival, T., Medical Ethics, 1803 (In Print, Cambridge University Press, 2014)
4 Canterbury v. Spence (464 F.2d. 772, 782 D.C. Cir. 1972)5.
5Menikoff, J., Law and Bioethics: An Introduction, Georgetown University Press, 2001
6Nixdorf v. Hicken (612 P.2d 348. Utah 1980)
7Gates v. Jensen (92 Wn.2d 246 Washington 1979)
8Truman v. Thomas (27 Cal. 3d 286 1980)
9 Johnson v. Kokemoor (545 N.W.2d 495 Wis. 1996)
10https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf
11Calaprice, A, ed. The Ultimate Quotable Einstein, Princeton University Press, 2010 (The real quote from Einstein’s 1933 lecture is, “It can scarcely be denied that the supreme goal of all theory is to make the irreducible basic elements as simple and as few as possible without having to surrender the adequate representation of a single datum of experience.”)
12Newman, C. “It Is All About Consent,” Contact Lens Spectrum, Feb. 2019
Clarke D. Newman, OD, FAAO, FBCLA, FSLS, FNAP
