This Guidance for Priority Setting in Health Care (GPS-Health), initiated by the World Health Organization, offers a comprehensive map of equity criteria that are relevant to health care priority setting and should be considered in addition to cost-effectiveness analysis. The guidance, in the form of a checklist, is especially targeted at decision makers who set priorities at national and sub-national levels, and those who interpret findings from cost-effectiveness analysis. It is also targeted at researchers conducting cost-effectiveness analysis to improve reporting of their results in the light of these other criteria.The guidance was develop through a series of expert consultation meetings and involved three steps: i) methods and normative concepts were identified through a systematic review; ii) the review findings were critically assessed in the expert consultation meetings which resulted in a draft checklist of normative criteria; iii) the checklist was validated though an extensive hearing process with input from a range of relevant stakeholders.The GPS-Health incorporates criteria related to the disease an intervention targets (severity of disease, capacity to benefit, and past health loss); characteristics of social groups an intervention targets (socioeconomic status, area of living, gender; race, ethnicity, religion and sexual orientation); and non-health consequences of an intervention (financial protection, economic productivity, and care for others).
Current ethical guidance for research on human subjects is primarily concerned with protecting study participants.* They are, after all, the "human subjects" whose interests are the focus of oversight. But researchwhether on human subjects or not-may also strongly affect individuals who are not study participants. US law defines study participants as living people about whom data are obtained through intervention or interaction or about whom identifiable private information is collected (1). Many individuals about whom no data are obtained through intervention, interaction, or other means can be affected by a study. A complex ethical question therefore arises. What protections are owed to study nonparticipants? Except in the case of fetuses (a relatively complex case in light of their debatable moral status), US law governing all federally funded research does not address risk to nonparticipants (1). Although guidance exists Research on human subjects can affect people other than the subjects. What protections are owed to study nonparticipants? Image courtesy of Dave Cutler (artist).
Till Bärnighausen and colleagues respond to comments by the HPTN 071 (PopART) Study Team, noting the distinction between the different HIV prevention questions the trial will attempt to answer.
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