Abstract
BackgroundInternational documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic.DiscussionOur analysis and interpretation of the concept social value has led to three proposals. First, as no direct benefits are expected for the research participants in first-in-human trials, we believe it is better to discuss a risk- value assessment instead of a risk - benefit assessment. This will also make explicit the necessity to have a clear and common use for the concept social value. Second, to avoid confusion we propose to limit the concept social value to the intervention tested. It is the expected improvement the intervention can bring to the wellbeing of (future) patients or society that is referred to when we speak about social value. For the sole purpose of gaining knowledge, we should not expose humans to potential harm; the ultimate justification of involving humans in research lies in the anticipated social value of the intervention. Third, at the moment only the validity of the clinical research proposal is a prerequisite for research to take place. We recommend making the anticipated social value a prerequisite as well.SummaryIn this paper we analyze the use of the concept social value in research ethics. Despite its unavoidable ambiguity, we aim to find a best use of the concept, subject to its role in justifying involving humans in first-in-human research.
Highlights
International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits
Summary: In this paper we analyze the use of the concept social value in research ethics
Summary the concept social value is by nature ambiguous, and confusion may be hard to avoid, we have proposed to employ the concept ‘anticipated social value’ in research ethics to refer to the nature and magnitude of the improvement an intervention is expected to have on the wellbeing of patients
Summary
International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. A direct benefit cannot be excluded in phase I trials, they are not the purpose of the study and should not play a role in the evaluation This is especially evident when healthy volunteers are used for these early human trials. We will propose to limit social value to refer to the anticipated improvement the intervention will bring, which is what we believe would be the best use of the concept. This is important for we deem the anticipated social value of the intervention should be a prerequisite for research to involve human participants.
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