The Helsinki Declaration, first published in 1964, is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration was formulated in response to the abuses of human subjects by the scientists in Nazi Germany and to update the Nuremberg Code. Amended in 1975, 1983, 1989, 1996, and 2000, the Declaration provides the foundation for the United States federal regulations for research involving human subjects.To conform to standards developed in the Declaration, a researcher must fulfill the following: (...) respect the autonomy of the individual; promote and safeguard the individual’s health; provide informed consent without coercion; take special measures with vulnerable populations; compare new therapies to the best current therapies; have a thorough scientific knowledge of the subject; assess risk versus benefit of the intervention; perform studies that will ultimately benefit the population involved in the research; accurately report their findings; and fully disclose ethical concerns in their research protocols. (shrink)

The Helsinki Declaration is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration calls for research studies to compare new therapies to the best current therapies. Despite this standard, multiple studies of pain relief interventions in newborns have recruited placebo controls instead of active controls using the best current therapy. These studies are evaluated using the standards required by the Helsinki Declaration, and the reasons for the ethical shortcomings of these studies are explored.