Retorno de la bioética en ensayos clínicos

Abstract

Biomedical research ethics is a hot topic in USA today as it used to be when it was born three decades ago. New procedures to preserve and protect the scientific integrity and the human subjects involved in clinical trials are the response to the increasing distrust in scientific protocols, which some times do not follow the orthodox ethical standards, and many a times have developed some harm to participants becoming a threat to national human research policies. The new scene of investigation associates both the academic knowledge and the private enterprise; though not a novelty it shows now an exceptional financial increment by the pharmaceutical and biotechnological industries. In this sense, the industry changes the financial support from the academic to the private medicine -of a profitable nature- grounded on intermediary organizations that manage clinical trials providing the access to hospitals, health professionals, and patients. The concern then lies on this approach to managing clinical trials as long as investigation quality and human subjects are involved, mainly as regards the conflict of economical interests that arise among professionals and "non institutional" revision committee members. The consequence is a proposal of new rules for the handling of those conflicts of interests and the encouragement of education in bioethics for clinical researchers and revision committee s members.