Abstract
Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent?
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Notes
Much of the present analysis applies to research with all nonhuman animals. However, consistent with the theme of the present collection, I will focus on research with nonhuman primates. The proposal from Gagneux et al. [1] involves research with great apes.
The standard benefits to human beings involve improvements in human health and well-being. Research studies also sometimes offer financial benefits for funders and gains in knowledge per se.
In the research context, risk is a term of art that refers to harms that may occur, as well as to harms that are certain to occur; the inevitable pain of a blood draw constitutes a ‘risk’ of research participation. I will follow that usage here, although when it seems important to be particularly clear, I will specify both risks and harms. Also, it is worth noting that this terminology does not assume that being exposed to risks is per se harmful to subjects.
The qualifier to “willfully” causing the suffering is intended to refer to the conditions, whatever they might turn out to be, that are sufficient for it to be the case that the agent is morally responsible for his actions.
There is also the theoretical possibility that nonhuman primate interests have greater moral significance.
A large part of the problem here is that these data would be difficult to collect. The most straightforward, albeit ethically problematic, approach would be to take a range of interventions that fail in nonhuman primates and test them in human beings. An alternative approach would be to take interventions that are known to be effective in human beings, but have never been tested in animals (e.g., interventions that were adopted before animal testing was required), and test them in nonhuman primates. Interestingly, this latter option offers one example of nonbeneficial research with nonhuman primates that might benefit other nonhuman primates (by possibly showing that research with nonhuman primates is counterproductive for the purposes of improving human health and well-being).
Although I will not consider them here, there are some reasons to think that the limitations on research with nonhuman primates should be stricter than the limitations for human beings who cannot consent.
Readers who assume that the fact most children will become competent is relevant to this example can regard the child as one who does not have the capacity to develop competence.
A complete analysis here would need to consider the relevance of the moral status of the subjects in question. It might be morally worse to inflict suffering on uncomprehending individuals who have higher moral status compared to uncomprehending individuals who have lower moral status. If this is right, and human beings have higher moral status than nonhuman primates, the moral costs of inflicting suffering on them would be lower to some extent. Making this determination would require an analysis of the extent to which the moral costs of inflicting suffering on uncomprehending individuals depends only on the amount of the suffering and the moral status of the subject, and to what extent it also takes into account the moral status of the agent; perhaps it is worse for individuals with greater moral status to inflict suffering.
One of the challenges with implementing this requirement is identifying the relevant class to which the individual belongs. Does this requirement imply that rhesus monkeys may be enrolled in research to help other animals, other primates, other monkeys, other rhesus monkeys, other rhesus monkeys of a similar age, with a similar health profile?
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Acknowledgements
Thanks to Tom Beauchamp, John Gluck, Leslie DeRenzo, Sam Garner, John Phillips, Hope Ferdowsian, and Tina Rulli for helpful discussion and suggestions on earlier versions of the manuscript. This work was completed as part of the author’s official duties as an employee of the US NIH Clinical Center. However, the views expressed are the author’s own. They do not represent the position or policy of the NIH, DHHS, or US government. The NIH had no role in the analysis, writing of the manuscript, or the decision to submit it for publication.
Conflict of interest
The author has no conflicts of interest with respect to the present work.
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Wendler, D. Should protections for research with humans who cannot consent apply to research with nonhuman primates?. Theor Med Bioeth 35, 157–173 (2014). https://doi.org/10.1007/s11017-014-9285-5
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DOI: https://doi.org/10.1007/s11017-014-9285-5