Standards and operational guidance for ethics review of health-related research with human participants
The new WHO publication “Standards and operational guidance for ethics review of health-related research with human participants”, is a compilation of 10 standards that are applicable to the ethics review of health related research with human participants. This document is intended to provide guidance on the research ethics review process, not to take a substantive position on how particular ethical dilemmas in health-related research should be resolved. It is designed to serve as a basis upon which Research Ethics Committees (RECs) can develop their own specific practices and written procedures, and benchmark their achievements.
The term “standards” is used to delineate general principles and norms that all research ethics systems are expected to follow. This publication highlights the importance of a systems approach to research ethics, and includes and delineates the role of national governments and relevant legal and regulatory authorities.