Evidence generated through responsible clinical research is one of the major pillars of the advancement of health care. In past decades there has been tremendous progress in the clinical research and development (R & D) environment globally, with increasing attention being paid to the health needs of people in resource-limited settings, where most of the preventable morbidity and mortality occurs. However, financial, social, ethical and regulatory challenges persist in low- and middle-income countries (LMICs), and most clinical research today is still being conducted in and for high-income countries (HICs). The aim of this report is to provide balanced arguments to promote scientifically sound good quality clinical research in low-resource settings.
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization with the mission to advance public health through guidance on health research and policy including ethics, medical product development and safety. This report reflects the consensus opinion of the CIOMS Working Group on Clinical Research in Resource-Limited Settings, and was finalized in line with comments received during public consultation. The report is intended for governments and regulatory authorities, the research community and sponsors, as well as international organizations involved in funding or conducting research. The report provides a comprehensive set of recommendations to all major stakeholders. While it builds on the 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans, it is not intended to supersede those guidelines.