“The WHO has published the “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants”, which is a compilation of 10 standards that are applicable to the ethics review with human participants. To access the publication click on this link http://www.who.int/ethics/publications/en/ .
This guidance is 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 does not 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. As stated by Dr. Abha Saxena from the WHO, “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.”
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