REIGN Framework

Use of Research Evidence to Inform Guidance regarding Normative-ethical Topics


The World Health Organization (WHO) is the directing and coordinating authority for international health within the United Nation’s system. As such the WHO develops guidance for various actors on how to improve health and how to combat diseases in an ethically acceptable manner. The WHO has developed standards to ensure that available empirical evidence is identified and adequately considered in the development of guidance documents on more technical questions such as intervention effectiveness or cost-effectiveness. These standards build on the evidence-based medicine paradigm, established systematic review methods, and explicit evidence-to-decision frameworks (e.g., the GRADE/DECIDE framework).

In addition to such technical documents, the WHO also addresses ethical issues and their adequate handling in guidance documents. The processes for developing these types of guidance documents are not as well established, and it is much less clear what role evidence should play when discussing ethical issues or writing ethical recommendations. The WHO therefore initiated the REIGN (Use of Research Evidence to Inform Guidance regarding Normative-ethical Topics) project to develop a framework explicating the role of evidence in the development of ethics guidelines. 

The resulting “REIGN Framework”, authored by Dr. Corinna Klingler and Dr. Marcel Mertz, is currently available in a pre-edited version (see below). The REIGN framework consists mainly of the Discussion Paper of the same name, and of the “REIGN Toolkit”. The Discussion Paper identifies a concrete framework for how evidence can be considered in the development of ethics guidelines, and also addresses theoretical background assumptions about the use of evidence in ethics. The “Toolkit” is a brief summary of this framework with, among other things, checklists that can be used when developing ethics guidelines. The “Toolkit” is included in the main document, but can also be downloaded separately.