How can move forward the scientific and medical technology in a period of six months in Peru?
DOI:
https://doi.org/10.26512/rbb.v5i1-4.7858Keywords:
Government Regulation. Protection. Clinical Trials. Peru.Abstract
On July 29 of 2006 was published in the Official Gazette “El Peruano”, the Regulation of Clinical Trials of Peru with the Supreme Decree no. 017-2006SA. In the wake of this fact Peru was the target of promising comments, since the mentioned regulation has come to be considered innovative by part of the scientific community nationally and internationally. However, on January 16th 2007, was published on the web page of National Ministry of Health a proposed amendment to the Regulation, arguing that the great advances in medical science produced in the last 6 months (time of validity of Supreme Decree no. 017-2006SA) have caused it is obsolete. We make an argument of the need for regulation on clinical trials in Peru and the process of over 2 years that had for its publication. Also, we discussed the proposed changes and its correlation with the progress of science and medical technology, not finding a rational basis for this amendment and rather opened a gap that violated the protection of the rights of the participants in the investigation.
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