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ETHICAL EVALUATION IN HEALTH TECHNOLOGY ASSESSMENT

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Background and objectives - Addressing ethical issues in health technology assessment (HTA) can increase transparency and accountability of the HTA process and lead to better-informed healthcare decisions. Despite its importance, integration of ethics into HTA remains challenging. The objective of this thesis was to develop a process-based framework to support ethical evaluations in HTA and increase their applicability. Methods - Project 1: A systematic literature review was conducted with the purpose of identifying and mapping the methodological features of the existing frameworks for ethics in HTA. Project 2: A systematic literature review and an international survey of HTA agencies were conducted to explore how ethical evaluations may be encouraged or discouraged in the HTA practice. Project 3: A procedural framework was drafted based on the operational features of the identified guidance documents as well as barriers and facilitators for incorporating ethics into HTA. Project 4: The framework was applied to a hypothetical case study, with the aim of helping HTA practitioners touch on key points of the steps outlined by the proposed framework. Results - Project 1: The identified ethical frameworks vary in their purpose, philosophical approach, structure, and comprehensiveness. The review results suggest that the choice of a method for collection and analysis of ethical data depends on the context, purpose of analysis, and availability of resources. Project 2: The results of this study emphasize the importance of simplification of ethics methodology and development of good practice guidelines in HTA, as well as capacity-building for engaging HTA practitioners in ethical analyses. Project 3: The proposed framework consists of an algorithmic flowchart, showing different steps of an ethical evaluation throughout the HTA process; a stepwise guide, which focuses on the tasks and potential questions that are required to be addressed at each step; and a list of some commonly recommended tools to facilitate the evaluation process. Project 4: The case study outlines the key tasks, recommended by the framework, and provides examples of process outputs that could be considered when attempting to perform an ethical evaluation. Conclusions - The outputs of this thesis can be used to support and promote a more consistent practice of ethical evaluation among HTA professionals. However, further validation of the proposed framework is required to establish its utility for HTA practice.

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