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.

Contents

• Acknowledgements
• Preface
• I. Standards for the research ethics review system
  • Standard 1 Responsibility for establishing the research ethics review system
• II. Standards and guidance for entities that establish research ethics committees
  • Standard 2 Composition of research ethics committees
  • Standard 3 Research ethics committee resources
  • Standard 4 Independence of research ethics committees
  • Standard 5 Training the research ethics committee
  • Standard 6 Transparency, accountability, and quality of the research ethics committee
• III. Standards and guidance for members of the research ethics committees
  • Standard 7 Ethical basis for decision-making in research ethics committees
  • Standard 8 Decision-making procedures for research ethics committees
• IV. Standards and guidance for the secretariat, staff, and administration of the research ethics committees
  • Standard 9 Written policies and procedures
• V. Standards and guidance for researchers
  • Standard 10 Researchers' responsibilities
• Annex 1 Guidelines and codes of best practice and statutes and regulations
• Annex 2 Guidance for developing terms of reference for the Secretariat of the research ethics committee
• Annex 3 Guidance for developing written procedures for the research ethics committee
• Glossary

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