Abstract
BACKGROUND: While evaluation of ethical aspects in health technology assessment (HTA) has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment (HTA) methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA. METHODS: The framework was developed through the following phases: 1) a systematic review and content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework. RESULTS: The proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process. CONCLUSIONS: The proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice.