The Informed Consent Obligation in Complementary and Alternative Medicine
Informed consent presents one of the major unresolved areas in the integration of complementary and alternative therapies into the health care system. Legal requirements of informed consent aim to protect the patient against non-consensual interference with his or her body in medical matters. Informed consent requires the physician to disclose, and ensure that patients (or authorized surrogates) comprehend, all information material to the patient’s decision to undergo or reject a specific medical procedure. Inclusion of complementary and alternative medicine in any such requirement is likely to have a significant impact on clinical practice….
To satisfy informed consent in biomedicine, physicians must disclose the nature of the problem, the purpose of the proposed treatment and the probability of its benefits and risks, as well as the probability of benefits and risks of alternative treatments or doing nothing. Whether such disclosure must, or should, encompass complementary and alternative modalities has not yet been addressed in the literature.
The question of appropriate disclosure becomes especially complex where treatments are supported by results of studies published in medical literature, but are not generally accepted or adopted by physicians nationwide. For example, is a surgeon obligated to advise the patient that there are reports that chiropractic care may be more effective, and less invasive, than surgery for certain cases of low-back pain? Should neurologists afford patients the opportunity of taking ginkgo biloba for improving dementia due to circulation problems, and possibly Alzheimer’s? To what extent must primary care physicians disclose information about the possible benefits of nutritional therapies, such as treatment of benign prostatic hypertrophy with saw palmetto and other herbal preparations, and treatment of depression with hypericum (St. John’s Wort)?
Such questions will multiply as studies are conducted with increasing rigor by research centers, including those funded by the National Center for Complementary and Alternative Medicine. In terms of practical guidance for the clinician, a starting point is the test for informed consent in conventional medicine: would a reasonable patient, in a similar situation, find the information regarding the complementary and alternative therapy to be material to the decision to use or forgo that therapy?
The issue of materiality may be difficult to answer, since some clinical choices may involve use of the therapy as an adjunct to conventional medicine, whereas others may involve a substitution. Nonetheless, asking this basic question forms a reasonable foundation for the physician in everyday clinical contexts to assess the legal boundaries of the informed consent disclosure obligation.
The above is adapted and reprinted with permission of Ann Arbor: University of Michigan Press from Chapter 3 of “Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution” (University of Michigan Press, forthcoming 2000).
The Legal Framework Governing Complementary and Alternative Medicine
Physicians, hospitals and health care institutions, insurers, managed care organizations, dietary supplements manufacturers, and patients, face numerous legal and regulatory issues as they contemplate greater utilization of, and access to, complementary and alternative therapies such as chiropractic, acupuncture, naturopathy, and herbal medicine.
Some of the unexplored legal frontiers for practitioners and institutions include:
- malpractice liability for the integration of complementary and alternative medicine into clinical practice
- legal issues surrounding scope of practice
- liability for referrals to complementary and alternative medical providers
- relevant food and drug rules
- questions surrounding professional discipline
- federal and state fraud and abuse laws
- legal rules governing third-party reimbursement.