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Is it ethical to randomize patients to treatment? Is it ethical NOT to randomize when a promising new treatment is available but has unknown efficacy? Can truly informed consent ever be obtained? When is the use of a placebo appropriate? Should treatment effects (beneficial and/or adverse) be monitored during the trial and how should interim results be used?

In many countries, research is not considered ethical unless it has been approved by an external review group charged with ensuring adherence to ethical standards (often referred to as an institutional review board or an ethics review committee). In most cases, participants must be informed about the nature of the trial as well as the potential risks and benefits of participating, and generally explicit consent for participation must be granted. The issue of when it is ethical to use a placebo (untreated group) for comparison is currently being debated.

In some cases, the interests of science conflict with those of community ethics. A case in point is the current requirement for gender and racial/ethnic "representativeness" in clinical trials sponsored by the U.S. National Institutes of Health. These and many other ethical issues are inherent in the design and conduct of clinical trials. Discussions of these topics are available in the current literature and in many internet sites.

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