Methodological guidance documents for evaluation of ethical considerations in health technology assessment: a systematic review

Abstract

Despite the advances made in the development of ethical frameworks for health technology assessment (HTA), there is no clear agreement on the scope and details of a practical approach to address ethical aspects in HTA. This systematic review aimed to identify existing guidance documents for incorporation of ethics in HTA to provide an overview of their methodological features. The review identified 43 conceptual frameworks or practical guidelines, varying in their philosophical approach, structure, and comprehensiveness. They were designed for different purposes throughout the HTA process, ranging from helping HTA-producers in identification, appraisal and analysis of ethical data to supporting decision-makers in making value-sensitive decisions. They frequently promoted using analytical methods that combined normative reflection with participatory approaches. The choice of a method for collection and analysis of ethical data seems to depend on the context in which technology is being assessed, the purpose of analysis, and availability of required resources.

Keywords::

• ethics
• frameworks
• health technology assessment
• methodology
• systeamtic review

Financial & competing interests disclosure

This research was supported in part by the Canadian Centre for Ethics and Corporate Policy’s Graduate Award. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The current guidance documents for ethical considerations in health technology assessment (HTA) are designed for different purposes throughout the HTA process such as helping HTA producers in identification, appraisal and analysis of ethical data, and supporting decision makers in making better informed value-sensitive decisions.

• The existing guidelines seem to vary in terms of their focus and recommendations across different HTA agencies based on the type of organization and its decision-making process.

• Four general procedural approaches are proposed for ethical analysis in HTA: reflection through ethical principles and theories, supplementing classical methods with participatory approaches, providing pragmatic tools for obtaining and synthesis of ethical data and integrating ethics in multicriteria HTA decision-making tools.

• Ethical frameworks frequently use analytical methods that combine normative reflection with participatory approaches, where stakeholders and citizens share and discuss different viewpoints and arguments.

• Existing methods are generally meant to be used by professional ethicists or HTA practitioners with a knowledge and skill in ethical analysis.

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