Bioethical and biolaw problems associated with research projects

Abstract

Every investigation must be orientated by bioethical principles. Qualitative research, with a case study approach, with the objective of analyzing the bioethical and biolaw issues associated with the research projects identified by the Research Ethics Committees in human health. Members of Human Health Research Ethics Committees from Medellin and its Metropolitan Area participated; it was done semi-structured interviews, followed by an analysis of the content. The following problematics were revealed: weakness in the scientific validity and in the bioethics argumentation about the research´s protocols; researcher´s imprecision roles; gaps and outdated Colombian regulations; inadequate assessment of risk, beneficence, and non-maleficence for the participants; inadequate informed consent processes; inadequate policy coverage; interest conflicts of researchers and members of the Human Health Research Ethics Committees. It can be concluded that the Human Health Research Ethics Committees evaluate the projects looking for a balance between the research policies and the participant´s rights. The researcher needs to ponder on the bioethics and biolaw aspects on his investigation, anticipate eventual situations in the investigation and the actions to prevent or solve them, applying the precautionary principle.