Overview
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.
The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.