The original Declaration of Helsinki (1964) has been subjected to numerous revisions and reformulations, supposedly necessary to keep apace with medical progress, but in fact leading to its loss of stability and authority. The Edinburgh 2000 revision made provisions for increased tolerance in the use of placebos, and loss of commitment to assure post-investigational benefits to individuals and communities involved. In spite of Argentina's and Brazil's manifest opposition, a double standard for research ethics became a de facto reality which has increasingly weakened the Declaration. Corporative interests of major stakeholders -researchers and sponsors- have been strongly supported as the Declaration becomes less protective of individuals and communities involved. It is therefore suggested that Latin American bioethicists would be well advised to develop a regionally pertinent normative in accordance with our social reality and the need of protecting our population.
Declaration of Helsinki; Ethics, research; Protection