Excepciones al uso del consentimiento informado en investigación: ¿cuándo es esto posible en Chile? / Exception to informed consent in research: when is this possible in Chile?

ABSTRACT

Exceptions or waivers to informed consent in research in Chile are an ethical issue that has not been addressed in all its complexity by the scientific community. The possible waivers to this process could make the difference for the feasibility, success or failure of a study. The purpose of this document is to clarify within the available information, what is the current situation about the exceptions to informed consent in research and what are the ethical-legal guidelines in Chile. Articles were reviewed in both English and Spanish from indexed journals and those documents that meet the inclusion criteria were selected. There is limited information available about waivers to informed consent, which indicates that the ethical guidelines are similar among countries that honor the Declaration of Helsinki, including Chile. However, the current Chilean legislation does not include exceptions. Ethics Committees that authorize research in line with international ethical guidelines could allow possible exceptions. Based on our findings, it is necessary to evaluate possible exceptions for informed consent for research performed in Chile, both from the legal point of view and based on the experience of scientists.