Towards (more) evidence-based ethics guidelines: devising the REIGN framework.

Abstract

Background: While the last decade has seen the increasing refinement of methods for evidence collection and synthesis for clinical guidelines or health policy decision-making, no similar methodological advances can be observed for ethics guidelines. Accordingly, the evidence base of ethics recommendations often remains opaque. The 'REIGN' framework fills this gap by addressing how evidence can (and possibly should) be used to develop ethics guidance.

Methods: A 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 were searched. The literature found was read and summarised. Through further conceptual analysis of the arguments, terminology and ideas provided in the literature the REIGN framework was developed.

Findings: The framework consists of two parts. First, it provides a definition of evidence that is productive for the field of ethics while incorporating key ideas behind the evidence-based medicine movement. It also introduces 'normative evidence' in contrast to empirical evidence. Second, it identifies five 'evidential support components' (ESCs) as aspects of developing normative recommendations in the health context that can/should be substantiated by evidence. It also provides guidance regarding possible sources of evidence as well as quality appraisal of normative evidence.

Conclusions: By 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.