WHO publishes standards for human subjects research

by Avery Avrakotos, Education and Policy Coordinator

When not serving as a member of the faculty at PRIM&R’s Advancing Ethical Research Conference, Nancy Kass, ScD, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, plays an integral role in the development of research policies for human subjects research.

As a member of the World Health Organization (WHO) Research Ethics Secretariat in Geneva (2009-2010), Kass served on a team tasked with preparing a new set of ethical guidelines for research with human participants. 

“Our goal was to provide global guidance and a minimum set of standards that research ethics committees (RECs) throughout the world are expected to follow,” said Kass. The team’s efforts resulted in the publication of “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.”

The document, a compilation of 10 standards for ethics review, outlines standards and guidance for RECs members, committee staff, and the institutions that constitute and oversee such committees. It is based on existing international guidance documents and was created in response to recommendations that the WHO provide benchmarks by which RECs could measure performance and procedures.

“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,” said Kass.

What is your take? Have you reviewed the WHO guidance? Does the document meet its stated aims?

Thank you to Nancy Kass and the Media Relations Office of the Johns Hopkins Berman Institute of Bioethics for providing the content for this post.