Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

A “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants” overview has recently been published, and may be found attached to this article, or at http://www.who.int/ethics/publications/en/. This document is a compilation of 10 standards applicable to the ethics review of health related research with human participants.

The term “standards” in this book is used to delineate general principles and norms that all research ethics systems are expected to follow. They are intended to help RECs achieve high quality performance and to provide a common language that establishes specific outcomes or characteristics against which achievements can be benchmarked. The standards put forward in this document do not represent new ideas for REC functioning. Rather, they are based on requirements for RECs delineated in existing international guidance documents. Accompanying the standards are a series of “operational guidance” points which reflect commonly used strategies for implementing and fulfilling each of the standards.

This document is intended 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 complement existing laws, regulations, and practices and to serve as a basis upon which RECs can develop their own specific practices and written procedures. It is not intended to replace the need for national and local guidelines for the ethical review of research involving human participants, nor to supersede national laws and regulations. Indeed, it is hoped that this document will be useful to those charged with drafting national, local, and institutional regulations and policies, and that it will enhance the quality of RECs worldwide.