CAMLAW: Complementary and Alternative Medicine Law Blog

Informed Consent in Complementary and Alternative Medicine.

The popularity of complementary and alternative medicine (CAM) poses serious challenges for the physician and other providers, not the least being the issue of informed consent.

In Ernst EE, Cohen MH. Informed consent in complementary and alternative medicine. Arch Intern Med 2001;161:19:2288-2292, my colleague Edzard Ernst, MD, PhD (from across the Atlantic at the University of Exeter) and I review the legal and ethical implications of informed consent in CAM therapies.

Dr. Ernst and I argue that informed consent should include adequate information about the risks and benefits of all treatment options. The information about potential risks, including frequent, nonserious adverse affects as well as infrequent serious complications, is crucial for patients to know. Failure to disclose the availability, benefits, and risks of CAM treatments could give rise to malpractice claims. We discuss the existing US case law and several hypothetical scenarios. The ethical rules physicians follow in conventional care usually can be applied to treatment with CAM. The focus must be on expressing risks clearly, documenting informed consent adequately, and keeping up-to-date with the emerging evidence on CAM.

In the article, we give a number of hypothetical scenarios and talk about the look and feel of legally adequate informed consent. Essentially, clinicians should discuss the benefits and risks of all therapies, whether conventional or CAM, that are "material" to the patient's treatment decision. Some states judge materiality by "reasonable physician" standard and others by the "reasonable patient." But informed consent is more than disclosure: it is a conversation between two persons with shared decision-making as to possible outcomes and the optimal result.

Here is the extract: "THE INCREASING popularity of complementary and alternative medicine (CAM) poses serious challenges for the physician, not the least being the issue of informed consent. Herein, we review the implications of informed consent. Informed consent should include adequate information about the risks and benefits of all treatment options. The information about potential risks, including frequent, nonserious adverse affects as well as infrequent serious complications, is crucial for patients to know. Failure to disclose the availability, benefits, and risks of CAM treatments could give rise to malpractice claims. We discuss the existing US case law and several hypothetical scenarios. The ethical rules physicians follow in conventional care usually can be applied to treatment with CAM. The focus must be on expressing risks clearly, documenting informed consent adequately, and keeping up-to-date with the emerging evidence on CAM."

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COMPLEMENTARY & ALTERNATIVE MEDICINE LAW BLOG

Michael H. Cohen, Esq.; 468 North Camden Dr. | Beverly Hills, California 90210 | 310-844-3173