Ethical research issues: Going beyond the declaration of Helsinki

La Vaque and Rossiter made a strong, supported argument that it is unethica l to use a "no treatment" control group in a research study ifa known, effe ctive treatment is available. Their argument is based on the supposition th at the Declaration of Helsinki is the ethical world standard for research w ith humans. Their argument appears to be straightforward, but is not simple to apply. The issues are very complex, include issues not discussed in the ir argument, and can lead to a different conclusion as pointed out in this paper: The World Medical Association developed the Declaration of Helsinki as one of their official policies. The Declaration of Helsinki, however is not accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations or even by the United States Fed eral Government. Perhaps it is not mentioned because its ethical provisions are aspirational rather than mandatory as implied by La Vaque and Rossiter : Researchers and clinicians should also be aware of other ethical issues n ot directly discussed in the La Vague and Rossiter paper The Belmont Report is the basis for the ethical protection of human research subjects for at least 17 federal agencies and does not mention the Declaration of Helsinki. The Belmont Report mentions several ethical principles that form the basis for informed consent risk/benefit assessment, confidentiality of data, sub ject selection, Institutional Review Boards, and other protections needed w hen doing research with human subjects. Ar least 2 of these core principles have direct implications to the discussion related to the use of placebo c ontrols. The ethical principle of fidelity is also important in guiding res earch activities with human subjects. Researchers should be familiar with t he La Vague and Rossiter argument, the Belmont Report, and the federal poli cies developed to implement the provisions of that report, for example, Reg ulation 45 CFR 46.