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

Area of Science:

• Bioethics
• Health Policy
• Evidence-Based Practice

Background:

• Methodological advancements in evidence synthesis for clinical guidelines contrast with a lack of progress for ethics guidelines.
• The evidence base for ethics recommendations is often unclear, hindering robust decision-making.
• The REIGN framework aims to address this gap by detailing evidence utilization in ethics guidance development.

Purpose of the Study:

• To introduce a structured framework, REIGN, for integrating evidence into ethics guideline development.
• To define 'normative evidence' and its role alongside empirical evidence in ethical contexts.
• To guide developers on the type, source, and appraisal of evidence for health ethics recommendations.

Main Methods:

• A comprehensive review of academic and grey literature was performed.
• Searches included PubMed and websites of institutions involved in ethics guideline development and health technology assessment.
• Conceptual analysis of the literature informed the development of the REIGN framework.

Main Results:

• The REIGN framework defines productive evidence for ethics, drawing from evidence-based medicine principles.
• It distinguishes between empirical and 'normative evidence'.
• The framework identifies five evidential support components (ESCs) for developing normative health recommendations and offers guidance on evidence sourcing and quality appraisal.

Conclusions:

• The REIGN framework provides structure to the discourse on evidence in ethics guideline development.
• It enables developers to systematically consider the necessity, scope, and methods for evidence seeking.
• This structured approach promotes more coherent and evidence-informed ethical guidance in healthcare.