What is the Declaration of Helsinki and why is it worthy of a doctoral thesis being devoted to it? The Declaration of Helsinki is one of the 20th century's most remarkable texts. In this document, the World Medical Association1 seeks to provide "a statement of ethical principles to provide guidance to physicians and other participants in medical research."2 Unlike many other much longer international documents,3 the Declaration of Helsinki sets forth its principles in less than 2000 words. It has risen, over its 40-year existence, to become one of the pre-eminent texts addressing ethical issues in medical research.
Historically, the Declaration of Helsinki has its roots in the Nuremberg Code. At Nuremberg in 1947, over 20 physicians and scientists were on trial for their part in a number of horrific medical experiments carried out under the Nazi regime.4 The Nuremberg Code was a statement outlining "Permissible Medical Experiments" and was the standard to which those on trial were held.
The World Medical Association, formed in London in that same year, spent most of the next two decades debating its own statement of ethical principles pertaining to medical research. Finally, in 1964, the original Declaration of Helsinki was adopted5 and stuck fairly closely to the principles articulated in Nuremberg. There was a major revision in 1975, which for the first time set out the requirement that proposed medical research be subject to review by an independent committee. There were minor revisions in 1983,1989, and 19966 but the quarter-century from 1975-2000 really saw the Declaration of Helsinki take a very authoritative position in the international world of medical research.
Yet, with the 54th and most recent amendment in October 2000, the Declaration of Helsinki finds itself in the midst of a storm of controversy. Two of the new paragraphs in particular, i.e., paragraphs 29 and 30, are at the centre of the controversy. Essentially these ask the question:
1. In what circumstances is it ethically acceptable to use a placebo (inactive treatment, sometimes called "sham" treatment) in medical research? Placebocontrols7 have many advantages and often result in a smaller number of subjects being involved in researcher for a shorter period of time than would be necessary if the control group were receiving active treatment. The drawback is that, for conditions where effective treatment exists, the people who receive placebo do not receive their usual active treatment.8 A corollary question arises: if active control groups are used, what should be the standard of treatment used in the comparator group? This is particularly pertinent in studies done in resourcepoor countries where health care standards may be minimal. If a clinical trial is done in such a population, what should be the standard of care in the control arm? Should it be the usual treatment available in that country? Or should it be the best treatment available anywhere in the world?
These questions depend partly on the nature of the research questions and are still the subject of much debate. Suffice it to say that paragraph 29 in its original form gave rise to so much controversy that the World Medical Association took the unprecedented step of issuing a "Note of Clarification" to this paragraph. It has recently been argued that this "Note of Clarification" does not clarify but rather does just the opposite!9
2. Another related controversy arose in paragraph 30 which states: "At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study." This addresses the issue of the responsibility of researchers to research subjects after the research is completed. The controversy particularly arises in the context of research sponsors from industrialised countries, undertaking research in resource-poor countries. …