Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards
Summary
These Operational Guidelines are intended to provide international guidance to health research sponsors for the establishment and functioning of data and safety monitoring boards (DSMBs). The guidelines are based on a review of the existing guidances and requirements for DSMBs from national and international organizations, as well as on observation of existing practices of DSMBs in countries and institutions around the world.
Ethical and scientific standards for carrying out biomedical research on human subjects have been developed and established in international guidelines, including the Declaration of Helsinki, the Council of International Organizations of Medical Sciences (CIOMS) International ethical guidelines for biomedical research involving human subjects, and the WHO and ICH Guidelines for good clinical practice. The WHO/TDR Operational guidelines for ethics committees that review biomedical research have contributed to the development of ethical review practices in health research, establishing an international standard for promoting quality and consistency in ethical review. Compliance with international ethical and scientific guidance in health research contributes to ensuring that the dignity, rights, safety, and well-being of research participants are promoted and that the results of investigations are valid.
For further information, and to request copies, please contact Dr J Karbwang