Why ethical guidance is needed for health policy and systems research

3 August 2015

On 23-24 July, experts debated key considerations for the ethical review of health policy and systems research (HPSR). The resulting recommendations will be incorporated into a guidance document for use by ethics review committees and institutional review boards. The guidance document is being developed by the Alliance, in collaboration with the WHO Department of Knowledge, Ethics and Research and the University of Zurich.

Expert consultation on guidance for HPSR, Zurich, Switzerland (23-24 July 2015)

Researchers and research ethics committees worldwide sometimes struggle with how principles for the ethical conduct of health research should be interpreted and applied to policy and systems research, including implementation research. Issues such as whether a project should be considered health research or practice and what risks – to the patient or to health providers/policy-makers – are commonly debated. Other challenges include how study participants and beneficiaries should be defined, and who should ultimately be held responsible for ensuring the protection of study subjects, particularly in instances when researchers are studying policy decisions that have already been made. This type of research engages with complex scenarios and situations that arise from real world contexts and the ethical implications are often more nuanced and subtle, but nonetheless important.

Why is not having guidance on HPSR a problem?

Currently no guidance exists to support ethics committees and researchers in addressing these complexities and nuances. Ethical review of health policy and systems research is not always clear, and a high degree of variability has been observed in the outcomes of these reviews. At the same time, researchers may not always be aware of the specific ethical considerations and risks that may arise from their projects.

How is the Alliance developing ethical guidance for HPSR?

Work has been commissioned to review existing guidance and resources in this area, to identify key issues, and to understand how well existing guidance are integrated. An expert group of health systems researchers, policy-makers and practitioners, ethicists and patient advocates representing over 10 countries convened 23-24 July in Zurich to review this work and identified the gaps and scope of issues for which guidance will need to be developed. As a follow up to this meeting, a draft guidance document will be developed and shared more broadly for feedback and comments.


For more information, contact Nhan Tran (trann@who.int).