February 13, 2012

WHO publishes new standards for human participant research

The World Health Organization has published “Standards and Operational Guidance for Ethics Review of Health-Related Research With Human Participants,” a compilation of 10 standards for ethics review of health-related research with human participants.

“Our goal was to provide global guidance and a minimum set of standards that research ethics committees throughout the world are expected to follow,” said Nancy Kass, a member of the team that prepared the standards. Kass is deputy director for public health at the Johns Hopkins Berman Institute of Bioethics and served as a member of the WHO Research Ethics Secretariat in Geneva in 2009–2010.

“It is important that countries, researchers and collaborators know the expected standards for high-quality research ethics committees and have guidance on how to create and maintain them,” Kass said.

The standards are based on existing international guidance documents; international experts recommended, however, that WHO create a document to provide benchmarks by which research ethics committees could measure their performance, as well as specific procedures by which to meet those standards. The document outlines standards and guidance for committee members and staff, and the institutions that constitute and oversee such committees. The document is available at whqlibdoc.who.int/publications/