Abstract

AMARO CHELALA, José Raúl  and  GONZALEZ REVUELTA, María E.. Informed consent in the performance of clinical trials. Rev Cub Med Mil [online]. 1998, vol.27, n.1, pp.54-61. ISSN 0138-6557.

Problems related to informed consent in clinical trials are approached in this work. Certain aspects which have been published in the international literature which evidenced the existance of standards and regulation known from the end of the Second World War with the proclamation of the Code of Nuremberg in 1946, and later with the Declaration of Helsinki in 1964, are reported. Certain problems which appeared during medical research with the application of this principle were pointed out, and reference was made to situations in Cuba. Also, it was taken into account the important development that has been taken place during such a short period of time regarding scientific research in public health. The creation of regulations, and advisory centers, their standards and regulations which respond to international requirements is also pointed out.

Keywords : CLINICAL TRIALS [legislation & jurisprudence]; INFORMED CONSENT; BIOETHICS; ETHICS MEDICAL.