Abstract

BALUJA CONDE, Ilquia. Bioética en ensayos clínicos: Su aplicación actual. Rev Cubana Med Gen Integr [online]. 1998, vol.14, n.4, pp.340-346. ISSN 0864-2125.

A literature review on international ethical regulations which have been set for the development of clinical trials together with the explanation of the present need for taking benefit/risk relation into consideration when experimenting with human beings are presented. Good clinical practice establishes that patients likely to participate in biomedical research works should freely and willingly give their consent without coercion after having been duly informed of the objectives, benefits and risks of the trial as well as existing therapy alternatives. The researcher should record and notify the revision and ethical committes and the ruling authorities responsible for drug control of all the adverse events that might occur in the course of a clinical trial. From the 70’s on, the accelerated development of medical-pharmaceutical and biotechnological industries in the world encouraged the emergence of contracted research organizations which partially or completely participate in the clinical evaluation of a new product to be registered and marketed. In fulfilling this task, the CRO should strictly comply with set ethical regulations for clinical trials. However, developed countries presently tend to couduct biomedical research in developing nations since this means lower research costs, greater opportunities for the manufacturer to ignore the ethical regulations set by these countries and the in-situ study of some indigenous health problems of these regions of the world

Keywords : BIOETHICS; CLINICAL TRIALS; HUMAN EXPERIMENTATION ETHICS PROFESSIONAL; INFORMED CONSENT.

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