Brussels, 06 Feb 2003
The European Group on Ethics in Science and New Technologies (EGE) has welcomed EU research funding directed towards developing countries but stressed the need for greater solidarity to fight poverty related diseases in a new opinion on the ethical aspects of clinical research in developing countries.
The opinion states that the fundamental ethical rules applied to clinical trials in industrialised countries should be globally applicable, as a weakening of the regulatory standards would be in contradiction to the fundamental principles of human rights and dignity.
According to the group's opinion, research activities should be in keeping with the Charter of Fundamental Rights, which states that, 'The Union is founded on the indivisible and universal values of human dignity, freedom, equality and solidarity.'
The European Commission has been stimulating scientific cooperation with developing countries since 1983 through successive framework programmes. Targeted areas for research have included health, agriculture and the environment. Most recently, the Sixth Framework Programme has made it possible for developing countries to benefit from EU funding in all research areas. In particular, a total of 600 million euro has been allocated to combat AIDs, malaria and tuberculosis.
Although the EGE states that developing countries should be given the same opportunities as industrialised countries, the opinion recognises that there are differences regarding their economic and social contexts.
'In developing countries, little or no infrastructure is available for the population at large, particularly concerning healthcare services. In addition, cultural differences may also exist regarding traditions, family or community structures and moral values.'
'Research activities involving human subjects cannot exclusively be assimilated to an economic activity subject to market rules.'
Clinical trials are an essential part of medical research to develop new treatments or new diagnostic methods. However, clinical trials are sometimes set up for commercial goals.
The opinion also calls for better partnership and cooperation between research scientists. Local scientists' involvement is very important throughout all the phases of clinical trials as 'their knowledge of local conditions and traditions is also necessary to identify local needs.'
To safeguard the rights of people, ethical committees from all participating countries should carry out scientific and ethical evaluation of the research protocol. In particular, the group underlines their support for EU initiatives to build local ethical committees in developing countries.
Concerning the use of placebos, the group calls for the same regulatory structure as found in European countries; failing to do so could lead to double standards for poor and rich countries, the EGE argues.
The opinion concludes by stating that negative as well as positive results of trials must be published and that the new knowledge acquired by a research project in a developing country must be made efficiently accessible to the scientific community and to the general population of the country where the research took place.