Evaluation of the functionality of the reports of the Council for International Organizations of Medical Sciences (CIOMS) in ethics committees, in research in Mexico City

Revista Colombiana de Bioética

Diana Lammoglia Alatristre¹  María de la Luz Casas M¹ 

[1] Universidad Panamericana;

关键词: bioethics;    research;    committees;    ethics;    adverse event;    cioms;   

DOI  :  https://doi.org/10.18270/rcb.v10i1.680

来源: DOAJ

【 摘 要 】

Scientific and technological advances are key for the development of new medicines and technologies. Particularly in medicine, it is necessary to generate knowledge that will improve the probability of success. All protocol should be authorized by the ethics research council, and its monitoring should be especially referred to the presentation of adverse and undesirable affects that should be valued, to guarantee an adequate risk/benefit for the patient. The most recognized instrument in this field is the Council for International Organizations of Medical Sciences’ (CIOMS) report used worldwide by the pharmaceutical industry. The general objective of this study consists in evaluating the functionality of the CIOMS report in committees in Mexico City, through a questionnaire validated by experts and applied to a sample of investigators and members of committees. The results show that this reports continue to be functional in some 80.5%, although 54.5% of the surveyed suggest the creation of a new instrument, with characteristics that the current one does not have. Nonetheless, it is evidenced that the CIOMS reports continues to be efficient, although with room for improvement.

【 授权许可】

Unknown