Stats: Ethical principles for Complementary and Alternative Medicine Research (2005-01-24)

Ethical principles for Complementary and Alternative Medicine Research created 2005-01-24)

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The National Academies Press, has a new publication available, Complementary and Alternative Medicine in the United States. This publication was prepared by the U.S. Institute of Medicine at the request of the National Institutes of Health and the Agency for Healthcare Research and Quality. You have to purchase the PDF files that constitute the book, but you can also browse through the contents and view a free executive summary.

One chapter title that immediately caught my attention was "An Ethical Framework for CAM Research, Practice, and Policy." The authors list five ethical principles that provide the foundation for their recommendations.

A social commitment to public welfare. In terms of medical therapies, a commitment to public welfare is the obligation to generate and provide to health care practitioners, policy makers, and the public access to the best information available on the efficacy of CAM therapies.
A commitment to protect patients and the public generally from hazardous medical practices and to inform practitioners, policy makers and the public of select therapeutic modalities that are potentially injurious or deleterious to health.
A respect for patient autonomy (or in social terms, a commitment to consumer choice in health care). Autonomy expresses the interest in allowing and actively enabling individuals to make knowing and voluntary choices in health care, in accord with their own values.
Recognition of medical pluralism. Serious consideration of the safety, efficacy and potential integration of CAM therapies into conventional medicine means acknowledgement of multiple valid modes of healing, and a pluralistic foundation for health care.
Public accountability. Were medical research and health care a private matter paid for by private funds and with few social consequences, such public accountability would not be required. Yet, health care, as well as the medical research that supports it, is a public trust that is largely funded with common resources and that has broad societal consequences. Accountability to the public for prudent and fair assessment and use of medical and health care resources is a necessary component of this report.

The first three principles relate directly to beneficence, nonmalificence, and informed consent, that were first outlined in the Belmont Report. The last two are new and interesting considerations.

Another interesting quote comments on biological mechanisms.

A therapy should not be excluded from consideration because it does not meet any one particular criterion—say, biological plausibility. However, the absence of such a mechanism will inevitably raise the level of skepticism about the potential effectiveness of the treatment (whether conventional or CAM). Moreover, the amount of basic research needed to justify funding for clinical studies of the treatment, and the level of evidence from those studies that is needed to consider the treatment as “established,” will both increase under such circumstances.

The authors also point out some innovative research methods, such as the patient preference trial and the attribute-treatment interaction model, that help with some of the difficulties associated with studying CAM approaches.

I have not read the full report, but it sounds like it addresses some issues about research that I touch on in briefly in my speech, Is the randomized trial the gold standard for research?

The National Academies Press also has several other intriguing publications: