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Table 2 Summarized assessment of the ethical approaches according to characteristics of complexity

From: Ethical analysis in HTA of complex health interventions

  Aspects of complexity
Ethical approach Plurality of perspectives Indeterminate phenomena Uncertain causality Unpredictable outcomes Ethical complexity
Principlism Hardly applicable: A limited number of perspectives are included, the implications of interactions between agents are partially included. Hardly applicable: Questions related to indeterminacy are not addressed. Hardly applicable: Data required by the approach indicates that methodological choices in the HTA process may be partially addressed. Hardly applicable: Ethical issues of outcomes are addressed, but not the uncertainties in outcomes as such. Fairly applicable: Conflicting of principles can be illuminated, but not always overcome (resolvability).
Casuistry Hardly applicable: Analogues can provide solutions taking different perspectives into account, but may not be suitable for joining/synthesizing/com-promising perspectives, or to address interconnectedness/interactions. Hardly applicable: Analogues can provide potential conceptions of indefinite phenomena, but there is a threat of over-simplification. Hardly applicable: Analogues may address uncertainties. However, whether the analogues will handle relevant potential uncertainties cannot be predicted. Hardly applicable: Analogues may address un-predictability, but it may also mask basic or dynamic challenges, such as unpredictable outcomes. Fairly applicable: Casuistry is excellent for finding solutions to morally challenging problems. However, Casuistry does not provide solutions to genuine paradoxes and aporias. It may be useful to highlight them, though.
Wide Reflective Equilibrium, (coherence analysis) Fairly applicable: WRE can take into account of multiple perspectives and differences in judgement of moral properties. Interaction between components may be addressed in the WRE process. Control and decision-making is issued by the aim of providing a coherent base for this. Applicable: The moral implications of the indeterminacy of the intervention or condition can be revealed and explored in discussions towards equilibrium. Fairly applicable: Do not address moral issues related to methodological choices in HTA in general, but recognises the uncertainties from context dependency and the importance of taking this in to account. Fairly applicable: Can accommodate different views of what constitute relevant end points. Unexpected outcomes may be interpreted as disruption of the equilibrium, calling for a renewed debate. Fairly applicable: WRE can reveal fundamental values at stake, take value conflicts into account, elucidate contractions and inform about their resolvability. The aim of WRE is clear, but quality of reporting is not explicitly addressed.
Interactive, participatory HTA approaches (iHTA) Applicable: iHTA is pre-eminently suited to take into account a variety of perspectives, and interaction between actors. Applicable: Indeterminacy of a technology and its use is acknowledged. Applicable: Stakeholder involvement in the assessment process facilitates addressing ethical challenges in methodological choices. Fairly applicable: The approach is likely to increase the range of outcomes taken into account, which indicates that the ethical challenges of this unpredictability are also addressed. Fairly applicable: Stakeholders may reveal fundamental moral or socio-cultural values involved, and may elucidate the resolvability of possible contradicting principles/values.
The HTA Core Model® Fairly applicable: Different perspectives are included through stakeholder involvement and cooperation with experts in other HTA-areas. Interactions/interrelations are not specified or related to ethical implications. Hardly applicable: Defining the technology and target group is addressed in another domain of the model. Ethical implications of indeterminacy of technology/condition, are not addressed, but an illustration of ethical relevance of defining the target group is given. Fairly applicable: Morally relevant issues related to methodological choices are addressed in the introduction to the core model, and to some extent in the ethics domain. Factors contributing to uncertain causality are not specifically included, but context is indirectly considered though context dependent values. Applicable: Outcome uncertainties are addressed in the “beneficence/non-maleficence” issue, and in some other parts of the model. Fairly applicable: Some fundamental values are directly addressed, others may be revealed by stakeholder involvement, which also may reveal contradicting principles/values. The contribution to handling conflicting concerns is limited. The (common) reporting structure contributes to transparency.
The Socratic approach Fairly applicable: Identifies actors and stakeholders, and their perspectives, interest etc. Normative implications of interactions between agents (and components in general) are partly covered. Decision-making and responsibilities are also touched upon. Fairly applicable: Provides a means for exploring various definitions/under-standing of the interventions. The moral impact of indeterminacy is not directly addressed, but may be illuminated through related questions. Applicable: Morally relevant methodological choices in HTA are well addressed, which can contribute to an improvement in taking causal pathway uncertainties into account. Fairly applicable: Variety in outcomes is not specifically addressed, but rather a series of moral question about different potential outcomes. Fairly applicable: Reveals fundamental values and contribute to elucidate contradictions. The clear descriptive aim limits the contribution to handling conflicting concerns and contradictions. Comprehensiveness and transparency in reporting is emphasised.