Advances in medicine depend on innovative and bold clinical research. Much of the progress we have seen in the effectiveness and safety of disease treatment, diagnosis and prevention is the result of intensive research involving human subjects. This research has undoubtedly been in the interests of the health of individuals and the general public. Clinical research, however, must be ethically acceptable as well as scientifically sound. Ideally, any clinical study conducted anywhere in the world should respect the same internationally recognized ethical standards.
In the years following the Second World War, scientific misconduct and a disregard for ethics were pervasive features of clinical research, and through the efforts of Henry Beecher, Maurice Pappworth and many others this became widely recognized in the 1960s (1, 2). The World Medical Association's Declaration of Helsinki, issued in 1964, was a significant milestone in the effort to eliminate such violations and establish ethical norms. Many countries have incorporated the Declaration in their national legislation. It has also been the source of more detailed national and international provisions such as the WHO Guidelines on Good Clinical Practice. The Declaration has been revised several times, most recently in October 2000, in response to new challenges, which include the following.
In industrialized countries research costs continue to rise steeply, suitable patients are in short supply, and clinical institutions are overloaded with research projects. Sponsors seeking a quicker and bigger return on investment are attracted to countries in which costs are low and untreated patients plentiful (3). Institutions and countries with little experience in medical research, representing diverse cultures and traditions, have thus become partners in multinational studies. It can be difficult to apply ethical principles, however universal they may seem, in developing countries without a tradition of scientific research or the infrastructure for it. At the same time it is in these countries that HIV/ AIDS, malaria, tuberculosis, diarrhoea, respiratory infections and other major diseases are most prevalent, and therefore where medical research on methods of prevention and control is most needed.
Attempts to respond to these pressures have raised hard questions. Is it not exploitative to use for clinical trials populations which cannot afford the products that eventually result from this research, making the benefits available only to the rich? How has the study in question affected the research subjects, their communities, or health care in their own country? Was there any agreement to make the new treatment available in the country concerned? If so, for how long? Is the new treatment affordable and sustainable there?
The revised Declaration of Helsinki (see pp. 373-374) attempts to respond particularly to questions of this kind, although consensus has been difficult to achieve. Article 19 of the Declaration states: "Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research." The Declaration does not call for any plan or prior agreement between the sponsor and the host country to this effect, however.
Article 30 states that at the conclusion of the study every patient participating in it should be assured of access to the best proven therapeutic method identified by the study. …