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Table 1 Stepwise guide for the ethical evaluation process in HTA

From: Steps toward improving ethical evaluation in health technology assessment: a proposed framework

Steps Evaluative tasks Potential questions
1) Defining the objectives and scope of the evaluation □ Clarify the objectives and the scope of the HTA project - What is the purpose of the HTA project (e.g., providing input for decision-making, formulating recommendations for practice guidelines, serving academic purposes)?
- What is the rationale for the assessment of the technology (e.g., changing current practice, uncertainty/disagreement about benefits or risks of the technology)?
- What are the information needs of potential users of the HTA findings?
□ Consider ethical issues around the HTA project itself - Why is the assessment undertaken? Who has requested it?
- Is there any special interest in the assessment or pressure from authorities, manufacturers, patient groups, etc.?
- Is there any conflict-of-interest concerns?
□ Identify existing knowledge base about the technology - Are there any characteristics of the technology that may raise ethical concerns (e.g., risk/benefit profile, utilization in vulnerable populations, access issues, modes of application)
- What is the current practice?
- What is the desirability of the technology (e.g., positive or negative utility values, QALYs)
- What are the costs and organizational requirements for the implementation of the technology?
□ Specify the objectives of ethical evaluation - What the HTA team/organization intends to achieve by performing and ethical analysis (e.g., a description of ethical issues around the technology, identifying and resolving uncertainties around implementation of the technology by learning about stakeholder values and societal interests or through philosophical reflection)?
2) Identifying stakeholders □ Identify potential stakeholders; engage key stakeholders to identify other stakeholders - Who (potential groups or individuals) might affect or be affected (benefit/loose) by the introduction of the technology (e.g., decision-makers, manufacturers, healthcare providers, societal actors, patients and their families)?
□ Identify the ways in which the above groups may be affected by the implementation of the technology - What are the potential consequences of implementing the technology on disadvantage groups (access, equity, etc.)?
- What are the potential consequences of implementing the technology on other stakeholders?
□ Identify the ways in which the above groups may affect the implementation of the technology - What are the known interests of stakeholders in the implementation of technology?
- What opportunities (level of power) do stakeholders have to get involved in making decision about the implementation of the technology?
3) Assessing organizational capacity □ Define key requirements - What are the policy directions and priorities of the HTA organization and how might these influence evaluation of ethical considerations?
- Is there a shared understanding of objectives and outcomes of HTA and ethical evaluation?
- Are the opinion leaders in the organization supportive of integrating ethics in HTA?
- Do the project timelines allow enough time for the completion of an ethical evaluation?
- Are there any feasibility issues regarding ethicist involvement or stakeholder engagement?
- Does the organization have any previous experience with ethical evaluations?
  □ Establish a team consisting of ethical expertise, HTA practitioners with experience in evaluation of normative aspects of healthcare technologies, and relevant stakeholders (when needed) - Is the ethical expertise available in house? If not, are any external ethicists available to be recruited for the purpose of this evaluation?
- Are there sufficient staff members with required characteristics (knowledge, skills and attitude) available to take part in the ethical evaluation?
4) Framing ethical evaluation questions □ Recognize potentially relevant ethical problems and solutions that may arise from the introduction of the technology - Is there any potential conflict between the technology and basic human rights, social and cultural values, patient’s autonomy, etc.?
- What are the moral characteristics of the technology (e.g., risk/benefit profile, health improvement at the individual and society levels)?
- Does implementation the technology require any life style modifications?
- What are the long term effects of the technology on the users, their family members, and society (e.g. psychological impact, discrimination)?
□ Map the current practice from an ethical perspective - What are the key problems with the current use of technology (e.g., costs, equity problems, privacy, misuse of technology, freedom)?
- What are the affected groups’ perceptions about the current practice?
□ Identify sets of governance steps that might be necessary to resolve potentially relevant issues - What solutions have been proposed to deal with the identified ethical problems?
- How effective these solutions have been reported to be?
□ List ethical issues around the technology - Have I been able to identify any ethical issues around the technology (e.g., outcomes of medical choices, society’s access to the technology, ethically controversial situations at political or local levels, and ethically challenging situations at societal or healthcare system levels)?
□ Justify what issues should be included in the ethical analysis, and why - Which of the identified ethical issues are more relevant to the HTA project’s goal, and why?
- Which of the identified ethical issues are more important, and why?
□ Use dialogues and/or other deliberative methods for input seeking from ethical and technical experts as well as potential users, if necessary - Has the plausibility of the identified ethical issues been stablished or discussed?
- What insights are available from experts or stakeholders to aid in finalizing ethical evaluation questions?
5) Ethical analysis □ Choose an appropriate methodology to address identified ethical dilemmas - What methodologies are described in the literature or have been employed by others to study similar problems?
- What theoretical paradigm is chosen by the research team to inform the ethical evaluation (utilitarian theory, deontological ethics, virtue ethics, etc.)?
- What is the most practical and reliable approach to collect and analyze ethical data, considering the purpose of analysis, available expertise and other resources and feasibility of stakeholder engagement (e.g., empirical approach [using quantitative data], philosophical approach [using ethical theories and principles], narrative approach [using facts, value judgments, and stakeholder preferences], or a mixed approach)?
□ Justify the choice of method - What theoretical paradigm best fits the evaluation questions? and why?
- How the selected approach might be helpful in answering evaluation questions?
□ Review existing information and acquire additional relevant information through:
- An extensive search in quantitative and qualitative literature
- Deliberative methods
- Have adequate data been collected to serve the purpose of the ethical analysis?
- What information is available in the literature about ethical, social or legal impact of the technology?
- Is there any (retrospective, current or futuristic) information available on the use of the technology in different social and cultural contexts?
- What arguments are available in the literature in favour of or against the technology?
- What are the stakeholders’ values and preferences?
- What controversies and potential conflicts exist at the local, societal and political levels around implementation of the technology?
□ Ensure data from all sources are considered for analysis - Has data from all possible sources collected for the ethical analysis (e.g., quantitative and qualitative evidence, stakeholder hearings, and expert opinion)?
- Is triangulation of data sources possible?
□ Examine the collected data for logic and coherence, validity and reliability - What is the level of internal consistency of data? Is the collected data reliable?
- Is there any self-contradiction or incoherence in the collected data? Does a fundamental logic exist among the collected facts and values?
- What are the e factors that could influence generalizability of the evaluation results?
□ Synthesize and integrate collected data (facts and values) into ethical arguments
- Apply the principles of biomedical ethics
- Perform philosophical arguments on the ethical questions from the perspective of ethical theories
- Reflect on possible solutions
- Does the implementation or use of the technology challenge the basic principles of biomedical (e.g., beneficence, non-maleficence, autonomy, justice, vulnerability,)
- What are the key arguments in favour of using the technology?
- What are the key arguments against implementation of the technology?
- Are clinical or economic benefits of the technology justifiable from the chosen (various) ethical perspective(s)?
- Are the arguments sound and clear?
- What are the possible options for acting, and their consequences?
□ Acknowledge your own values and philosophical interest - What is your position (perspective) on the matter?
- How would you interpret the data, if you were in the stakeholders’/policy-makers’ shoes?
- How confident are you that your position will remain the same in the matter over time?
6) Deliberation □ Discuss the results of evaluation with an expert group to assess their relevance and completeness - What do the experts have to say about the relevance of the collected data?
- Do the experts have any suggestions as to what other sources of relevant information are available?
□ Choose an appropriate method to discuss the results of ethical analysis with relevant stakeholders to seek their feedback on the results - Who are the appropriate stakeholders to take part in or provide feedback on the analysis?
- What are alternative sources of values for interpreting ethical analysis findings?
- What are the ways that encourage identified stakeholders to provide required information.
- What are the main concerns, preference, and emergent needs of stakeholders?
- To what extend the stakeholder engagement activities have captured required information?
□ Seek additional expert insight, if necessary, to ensure about the plausibility of the produced results during stakeholder hearings. - Is it required/worth to engage a group of experts in a discussion of the ethical evaluation results?
- Do you have any specific questions/uncertainties which you would like the experts to address?
7) Knowledge exchange/translation □ Refine your target audience that might be interested or may benefit from the results of HTA - Who is the target audience (e.g., policymakers, healthcare providers, patient groups, academic audience)?
□ Refine information needs of your target audience - What are the ways in which the report will be used (e.g., direct use of knowledge for problem-solving, conceptual use of knowledge for perception-shifting or understanding, political use of knowledge for supporting or challenging policy decisions)?
□ Structure a presentation format to address the information needs of target audience - How should the evaluation results be made available to users (in terms of content and format)?
□ Report the results of ethical analysis in a transparent and effective manner - Are the criteria and logic for the choice of methodology and selection of stakeholders disclosed?
- Are the identified gaps in the literature, concerning ethical issues and values, addressed?
- Are all favorable and non-favorable arguments reported?
- Are anticipated changes that may follow from the implementation of the technology discussed?
- Are the findings summarized and the most important value issues highlighted?
□ Integrate knowledge translation in all steps of the assessment - Has there been an integrated flow of information among team members working on different aspects of the technology (clinical, economic, ethical, social, legal, and organizational aspects) throughout the HTA process?