Questions to guide the ethics analysis of research involving humans (July, 2025)

This tool aims to facilitate the ethics analysis of research involving human participants, performed by a research ethics committee (REC) that is duly accredited by the competent authority. The REC’s ethics analysis should be conducted when reviewing a research proposal prior to its initiation and throughout the conduct of the study, as part of its ethics monitoring. These questions have been developed based on existing frameworks for ethics review and monitoring and the International Ethical Guidelines for Health-Related Research Involving Humans developed by the Council for International Organizations of Medical Sciences (CIOMS), and integrate and consolidate content from previous publications by the Regional Program on Bioethics of the Pan American Health Organization (PAHO). The questions do not cover every aspect that a REC must consider when reviewing or monitoring research, nor do they constitute a checklist. The REC should always conduct a deliberation considering the specific characteristics of the research proposal in light of the CIOMS Guidelines.