The Public policies and their influence on good bioethics practices in clinical research

Abstract

This article analyzes the topic of Bioethics with a perspective of active teachers / researchers. The research gives rise to a virtuous circle in which the generation of knowledge of clinical practice allows information to be translated into goods and services for health care. In Ecuador, SENESCYT, the highest instance in the administration of science and technology has no interference in the regulation of bioethics in human research; and on the other hand, the MSP whose function is to provide only health services has taken a leading role in this regard, and may lead to a conflict of interest. At the moment a hyper-regulation has been imposed for clinical studies. Thus, for example, while in developed countries, observational investigations with biological samples are classified as minimal risk and undergo an expedited review of the committees; in Ecuador, the sampling of biological samples must pass through an approval of the full institutional committee; and also need the approval of the MSP. This situation is further aggravated if an intervention study is desired, these additionally require the approval of the ARCSA, which has 36 requirements. To this problem it is necessary to add the time that the regulatory instances are taken for the approval of the projects, which easily exceed one year. The barriers indicated create a fertile scenario for non-compliance with regulations and the practice of corruption. One study found that clinical trials in Ecuador were significantly reduced, from 6.7% to 1.8% in recent years. The question then arises as to how ethical it is that the instances of control make it difficult for the university to fulfill its role of training human resources at the highest level and providing maximum benefit for the population. Why not consider that all clinical data generated by the provision of health services can be used for research purposes? To contrast, the law establishes that the inhabitants of Ecuador are organ donors unless each person indicates otherwise. It is necessary to change the current hyper-regulation in the practice of clinical research that is not ethical and that seriously damages the generation of knowledge and the training of human resources.