Informed consent in complementary and alternative medicine: current status and future needs.

Abstract

"Informed consent" is an action. It is a process that fulfills the pretreatment ethical obligations of provider to patient. Through the process, the provider discloses meaningful and realistic facts about positive and negative expectations concerning the proposed intervention and addresses concerns that are pertinent to the patient. Disclosure is of facts that are known or realistically expected to be known by a qualified provider regardless of background or product genus. The disclosure obligation does not vary with the background of the provider or the label given to the therapy. MD, nurse, naturapath, chiropractor, and licensed and unlicensed practitioner have the responsibility to provide quality information about the therapeutic worth of the intervention based on reliable data. This obligation pertains whether the intervention is standard, experimental, investigational, natural, alternative, complementary, or unproven. Misrepresentation of material facts voids consent and triggers legal liability. Today, the oncology community meets the informed consent obligation through a stepwise process that produces standards of care and builds studies and data collection to produce reliable outcome information on patient benefit. These data enrich the ability of a patient to consider and provide informed consent to treatment. In contrast, although there are some ongoing studies of complementary and alternative (CAM) therapies, there does not appear to be a groundswell of support for these activities within the CAM community. The development of standards of care and reliable information about CAM therapies appears to be seriously lagging and a disservice to obligations toward informed participation and consent by the patients seeking CAM interventions.