Ethics in HTA: Examining the "Need for Expansion".

The article by Daniels and colleagues on expanding the scope of health technology assessment (HTA) to embrace ethical analysis has received endorsement and criticism from commentators in this journal. Referring to this debate, we examine in this article the extent and locus of ethical analysis in HTA processes. An expansion/no-expansion framing of HTA is, in our view, not very fruitful. We argue that meaningfulness and relevance to the needs of the population are what should determine the extent of ethics in HTA. Once 'relevance' is the guiding principle, engaging in ethical analysis becomes inevitable as values are all over the place in HTA, also in how assessors frame research questions. We also challenge dividing the locus of ethical analysis into assessment and appraisal as this would detach HTA from its purpose, ie, supporting legitimate decision-making. Ethical analysis should therefore be considered integral to the HTA process.