from any newly validated therapies. The United States has yet to enact policies that ensure justice in the distribution of the fruits of research, even for conventional medical research. The stipulation of such goals for CAM would be a good precedent, although awaiting the adoption of such standards of justice will require major policy changes and the absence of such standards should not delay research on CAM.

The ethical norm of risk-benefit contains several principles, some of which were discussed above. These include the obligation to minimize risks to subjects during the trial (nonmaleficence), to enhance potential benefits (beneficence), and to ensure that the benefits to subjects or society, or both, are worth the risks incurred (proportionality and nonexploitation). For many CAM practices the absence of standardization among practitioners, combined with imprecise measures of outcomes, could make the risk-benefit ratio more difficult to assess when subjects are enrolled in a trial and thereby make the informed-consent process more vague and fragile. For example, many CAM therapies emphasize a concept of wellness that is more holistic and inclusive than typical outcomes research. Whether and how to include this more imprecise aspect of health into a clinical trial is a question of both epistemology and ethics, that is, both the research methodology and the ends that are valued and sought through research.

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. Some of those designated as vulnerable in the federal Common Code are categorized as such precisely because of their diminished capacity to give consent. More generally, it is now well recognized that subjects who are ill and who participate in research in a clinical setting, often with their regular doctors acting as researchers, are likewise in a vulnerable position with regard to informed consent (Appelbaum et al., 1987; U.S. Advisory Committee on Human Radiation Experiments, 1996). Here the issue is not subjects’ mental capacities, but their expectations, with the subjects often attributing more therapeutic potential to a research project than the evidence or the trial design warrants. This has been termed the “therapeutic misconception,”