Abstract

PACHECO PADRON, Ana Patricia  and  RAMOS GIL, Felicia Daelé. Which bioethical and bio-legal guidelines should be followed when performing pharmacogenetic and pharmacogenomic tests in psychiatry clinical trials in Colombia, to protect genetic data and the rights of research subjects?. rev.colomb.psiquiatr. [online]. 2021, vol.50, n.1, pp.57-63.  Epub May 18, 2021. ISSN 0034-7450.  https://doi.org/10.1016/j.rcp.2018.10.005.

This paper is the result of research, from the bioethics and bio-legal perspectives, on the existing guidelines in Colombia for the handling of pharmacogenomic and pharmacogenetic tests in clinical trials. Colombian legislation on this kind of research was reviewed and then compared with international and supranational standards. It was found that Colombia lacks specific legislation in this area, a situation that puts both participants and researchers at risk, from bioethical and legal perspectives. These risks should not be underestimated, as they compromise the ethical viability of clinical and basic research in our setting. In the end, a proposal, based on principles of ethics is made, proposing a series of actions for the creation and promotion nationwide of guidelines which can be used to shape legislation to be applied to protect the genetic data and the rights of subjects participating in these types of research studies in Colombia.

Keywords : Pharmacogenomics; Clinical trials; Psychiatry; Genetic data.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )