WHAT IS INFORMED CONSENT?
Informed consent is a consent to treatment based upon information given to a patient by a healthcare provider. In the case of Lyme disease, a healthcare provider should explain the diagnosis and all treatment options available to the patient. The risks and benefits of receiving the treatments should be explained, along with the risks and benefits of not undergoing each treatment option available. All treatment options should be explained to the patient regardless of the cost of the treatment or whether or not the treatment option is covered by the patient's health insurance.
It is the position of L.E.A.P. Arizona, Lyme Education Awareness Program, that all healthcare providers should be explaining the benefits and risks of each of the PUBLISHED TREATMENT GUIDELINES FOR LYME DISEASE published in the National Guideline Clearinghouse. Explaining BOTH PUBLISHED TREATMENT GUIDELINES to the patient will ensure that the healthcare provider is abiding by LEGAL INFORMED CONSENT GUIDELINES from the American Medical Association.
In addition, many physicians and patients refer to the Centers for Disease Control and Prevention (CDC) Lyme Disease website for information. UNFORTUNATELY, the CDC is NOT abiding by LEGAL INFORMED CONSENT GUIDELINES due to the fact that the CDC is giving preference to one set of published Treatment Guidelines (IDSA) and ignoring the fact that another PUBLISHED STANDARD OF CARE (ILADS) exists for the benefit of Lyme disease patients.
L.E.A.P. Arizona strongly urges the CDC to abide by LEGAL INFORMED CONSENT GUIDELINES by making available in plain view on their Lyme disease website BOTH PUBLISHED TREATMENT GUIDELINES, namely those from ILADS and IDSA. Doing so will show physicians and patients that the CDC, under direction of the United States Department of Health and Human Services, is abiding by the requirement to provide LEGAL INFORMED CONSENT to physicians as an example and to patients for their benefit.
These are the two PUBLISHED TREATMENT GUIDELINES which the CDC and healthcare providers SHOULD be utilizing to provide LEGAL INFORMED CONSENT to patients:
Infectious Diseases Society of America (IDSA)
Practice Guidelines for the
Treatment of Lyme Disease
(Published 2000)
AMERICAN MEDICAL ASSOCIATION
INFORMED CONSENT
This is an excerpt from the AMA Informed Consent, prepared by the American Medical Association, Office of the General Counsel, Division of Health Law, 1998:
“Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.
In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient:
● The patient’s diagnosis, if known;
●
The nature and purpose of a proposed treatment or
procedure;
●
The risks and benefits of a proposed treatment or
procedure;
●
Alternatives (regardless of their cost or the extent to
which the treatment
options are covered by health
insurance);
●
The risks and benefits of the alternative treatment or
procedure; and
●
The risks and benefits of not receiving or undergoing
a treatment or procedure.
In turn, your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.
This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states. (For more information about ethical obligations, see the AMA’s code of Medical Ethics, contained in the AMA PolicyFinder.
Providing the patient relevant information has long been a physician’s ethical obligation, but the legal concept of informed consent itself is recent."