Complementary and Alternative Medicine in the United States (2005) / Chapter Skim
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6 An Ethical Framework for CAM Research, Practice, and Policy
6 An Ethical Framework for CAM Research, Practice, and Policy
Pages 168-195
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From page 168... ...
The committee believes that five major ethical commitments must be embraced. These deserve explicit acknowledgment because they serve as presuppositions or premises of this chapter.
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From page 169... ...
Investigation of CAM practices entails a moral commitment of openness to diverse interpretations of health and healing, a commitment to finding innovative ways of obtaining evidence, and an expansion of the knowledge base relevant and appropriate to medical practice. This commitment to openness also includes reconsideration of
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From page 170... ...
. Although some conventional medical practices may seek and achieve a genuine integration with various CAM therapies, the hazard of integration is that certain CAM therapies may be delivered within the context of a conventional medical practice in ways that dissociate CAM modalities from the epistemological framework that guides the tailoring of the CAM practice.
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From page 171... ...
5. The first four ethical commitments (to personal and public beneficence, to protection, to patient autonomy and consumer choice, and to medical pluralism in the service of these aims)
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From page 172... ...
heritage of healing traditions. In this light, some CAM providers would prefer that their healing traditions remain outside conventional systems of care and reimbursement and beyond the reach of efforts at integration (Cohen, 1998; Eisenberg et al., 1998)
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From page 173... ...
An additional financial disincentive is the difficulty in securing a patent on many of these products. Yet, insofar as these products are part of health care practices and are labeled or used as such by the American public, the manner is which they are regulated should account for all five of the ethical commitments outlined here, including accountability.
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From page 174... ...
An additional aim of this chapter is to raise questions and flag areas that practitioners, researchers, and policy makers believe will need to be considered in greater depth. ETHICAL ISSUES IN CAM RESEARCH Over the past 60 years the major sources for guidance on the ethics of research with human subjects in the United States have been the Nuremberg Code (1946)
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From page 175... ...
have proposed a consolidation and synthesis of the diverse principles and norms in these various codes and statements into seven requirements which, if satisfied, "make clinical research ethical." Their synthesis provides a useful beginning point for considering the ethical challenges raised by CAM research. Social or Scientific Value The value of a research project is the extent to which it holds the promise of improving health or increasing knowledge important to health, when it is judged on either social or scientific grounds.
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From page 176... ...
Ethically, this presents a value-based choice between a more conventional scientific understanding of a validated CAM therapy and a more pragmatic stance that may not be consistent with current research standards for conventional medicine. In a parallel but slightly different context, regulations such as disciplinary provisions in medical licensing statues that divide the world of CAM therapies into such categories as "validated," "invalidated," and "nonvalidated" and do so partly in terms of theoretical "plausibility" should also be examined for both epistemological and ethical assumptions.
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From page 177... ...
Informed Consent Considered by many as the heart of research ethics, informed consent expresses the obligation of researchers to inform potential subjects of the purpose of research, its risks and benefits, along with the alternatives, in a manner that ensures that the participants understand these elements of research and can act freely to enroll or decline. Informed consent is one of the chief ways of promoting subject autonomy, or self-determination, which is the right of free choice based on one's own values.
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From page 178... ...
Here CAM therapies pose a potential issue of expertise in research oversight. Typically, IRBs consist of individuals with knowledge and expertise in conventional medicine modalities and research.
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From page 179... ...
ETHICAL ISSUES IN THE INTEGRATION OF CAM THERAPIES INTO CONVENTIONAL MEDICAL PRACTICE Although the major sources for modern research ethics have all been created within the past 60 years, some of the chief ethical precepts for conventional clinical practice enjoy a 2,500-year history. All Western ethical traditions for medical practice trace their origins to the Hippocratic Oath (sixth century B.C.E.)
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From page 180... ...
Nevertheless, the effort to integrate CAM therapies into conventional medicine practice can present the physician with a variety of ethical challenges. Given the prevalence of CAM use by the general public it is clear that many patients seen in conventional medical clinics are also seeing CAM providers or using CAM therapies.
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From page 181... ...
presented a helpful delineation of options for the physician in recommending, tolerating, or in some cases, actively proscribing CAM therapies to patients on the basis of an individualized risk-benefit assessment. The ethical analysis suggested for the clinical consideration of the use of a CAM therapy involves weighing the severity and the acuteness of illness; the curability of the illness by conventional forms of medical treatment; the degree of invasiveness, associated toxicities, and side effects of the conventional medical treatment; the availability and quality of evidence of the utility and safety of the CAM treatment; the level of understanding of the risks and the benefits of the CAM treatment, combined with the patient's knowledge and voluntary acceptance of those risks; and the patient's persistence of intention to use the CAM therapies.
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From page 182... ...
" At least a partial answer has been identified by Astin, who concluded that CAM providers seem to have norms and styles of interaction with patients that are more congruent with patients "values, beliefs, and philosophical orientations toward health and life." The reasons for the widespread and growing use of CAM therapies are many, but for Astin, one reason, arguably, is the public's desire for a kind of health service and a kind of patient-provider interaction that is sometimes not available through the services offered by conventional medicine. Further research comparing conventional medicine and CAM practitioners on biopsychosocial dimensions in the delivery of health services would be useful both for medical research and medical practice.
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From page 183... ...
In these cases, most physicians will possess neither the skills nor the inclination to learn and incorporate CAM practices, and indeed, integration into a single practice norm should not be the aim. However, it is also possible, and perhaps even desirable, for patientsconsumers that some proven CAM practices be incorporated into conventional medicine, for example, acupuncture for chemotherapy-induced nausea.
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From page 184... ...
It can be argued that it is unethical to offer any CAM therapy until evidence from an RCT is complete. The stronger argument is that judgments about how much evidence is enough must be referenced to a diversity of factors, including the efficacies of conventional medical therapies; the hazards of the CAM modalities in question, if any; the extent to which these CAM modalities are preferred by patients; and the overall quality of whatever evidence exists.
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From page 185... ...
While some tension between medical pluralism and an evidence-based approach is likely inevitable and probably productive, the committee suggests that some of this tension can be resolved by CAM research and that the concept of evidence-based medicine will need to be modified to accommodate the multiple approaches inherent within a pluralistic understanding of health care. Finally, when a clinician decides whether to offer, recommend, discourage, or accept a patient's use of CAM therapies or refer patients to CAM providers, ethical obligations and legal duties (or at least liability considerations)
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From page 186... ...
Any collision of values requires sensitivity to the patient's expression of interests that goes well beyond the legalistic requirements of informed consent, as well as attention to the malleable but important fabric of the therapeutic encounter. In this respect, the ethical commitment to medical pluralism should be considered as the physician wrestles with conversations involving patient decision making.
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From page 187... ...
A number of legal rules also attempt to balance these competing interests and values and to protect patients by combating fraud and enhancing quality assurance while offering access to therapies and honoring medical pluralism in creating models of integrative care. Complex combinations of such rules may govern decisions by clinicians and health care institutions that seek to integrate CAM therapies into conventional medical settings (Cohen, 1998)
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From page 188... ...
Constitution provides that the powers not delegated to the federal government by the Constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people, and this reserved power includes regulation of health care licensure. In each state, the medical licensing statute (or medical practice act)
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From page 189... ...
, whether it involves biomedical or CAM therapies, is generally defined as unskillful practice that fails to conform to a standard of care in the profession and that results in patient injury. CAM providers, like physicians and allied health care providers, can also be sued for negligence.
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From page 190... ...
. Although such liability considerations continue to be unsettled, they should not necessarily preclude clinically sensible referrals, based on an awareness of what CAM providers can and cannot offer the patient, and a shared conversation regarding the objectives (and limits)
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From page 191... ...
Notably, in reviewing the complex interaction of preeminent ethical commitments and relevant legal rules, the existing legal and regulatory framework emerged from late-nineteenth century rivalries between the "regular" physicians and their economic and ideological competitors (mainly, chiropractors and homeopaths) in the provision of health care services (Kaptchuk and Eisenberg, 2001; Rothstein, 1972; Shryock, 1967; Stevens, 1971; Starr, 1982)
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From page 192... ...
2002. Ethical considerations of comple mentary and alternative medical therapies in conventional medical settings.
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From page 193... ...
2004. Integrating complementary and alternative medical therapies in conventional medical settings: Legal quandaries and potential policy models.
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2004. Ethical issues concerning research in complementary and alternative medicine.
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From page 195... ...
1998. Physicians' ethical obligations regarding alternative medicine.
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