gms | German Medical Science

Background/research question: The last decades have seen health policy and clinical decision-making to be increasingly based on evidence. Alongside, the methods for evidence collection and synthesis have been strengthened and refined. However, methodological advances for the development of ethics guidelines have severely lacked behind. For many ethics guidelines, it is unclear how they were developed and, more importantly, on what (kind of) evidence the individual recommendations are based. To fill this gap, the World Health Organization commissioned the generation of a framework (“REIGN”) that addresses the question how evidence can – and possibly should – be used to develop and justify ethics guidance.

Methods: A scoping review of the academic and grey literature was conducted. To this end, PubMed and the websites of selected institutions engaged in ethics guideline development and/or health technology assessment (HTA) were searched. The literature found was read and summarized, providing the baseline for framework development. Through further conceptual analysis of the arguments, terminology and ideas provided in the literature, the REIGN framework was developed.

Results: The framework consists of two parts. First, it provides a definition of evidence that is productive for the field of ethics while remaining true to the key ideals behind the evidence-based medicine movement. It also introduces “normative evidence” in contrast to empirical evidence and discusses the differences and similarities. Second, it identifies five “evidential support components” (ESCs) which are operationalized as five questions that ethics guideline developers will have to answer based on available normative and/or empirical evidence. It also addresses sources of evidence for the different ESCs, and reflects on various aspects of quality appraisal of esp. normative evidence. In addition, it provides a toolkit including checklists and shortcuts for guideline developers striving to ensure their recommendations are informed by evidence.

Conclusion: By analyzing and structuring the dispersed discourses on the topic, the REIGN framework allows ethics guideline developers to think more coherently through the questions of whether, for what area and in what manner evidence should be sought in the process of development. The framework can be seen as a first step in the process of developing more evidence-based guidelines for the context of ethics.

The pre-edited version of the framework can be found here: https://www.mhh.de/reign-framework

Competing interests: This project was originally commissioned by the World Health Organization.