Should Protections for Research With Humans Who Cannot Consent Apply to Research With Nonhuman Primates?
This paper considers how and why current protections for research with humans who cannot consent (such as children and those with severe dementia) can apply to nonhuman primates. Navigating the slippery and often contentious questions around moral significance of nonhuman animals, the author gives compelling examples of research projects where using nonhuman primates would be clearly unacceptable. These are then used as a baseline for determining a general principle that “individuals who are unable to consent should be enrolled in nonbeneficial research only when, at the very least, there is sufficient reason to believe that the potential benefits of the research justify the risks it poses.” Though the author does not make claims around what might constitute justifiable benefits, he does offer interesting possibilities for how nonhuman primates can assent / dissent from particular research, even if they cannot officially “consent.”
David Wendler, an employee of the U.S. National Institutes of Health (N.I.H.) Clinical Center, states early on in his paper, “research with nonhuman primates and research with human beings who cannot consent are similar in two important ways: both involve subjects who can be harmed and who are unable to consent.” But he goes on to recognize that “current US regulations include very different protections for research with these two groups.” As one can imagine, there are very strict protections in place for humans who cannot consent, while safeguards for nonhuman primates are virtually non-existent. This would not be a problem, Wendler notes, if it turned out that the interests of nonhuman primates had no moral significance, or at least, significance we had to care about or respect. However, with a simple example (using a primate for painful research to test a new shade of lipstick), Wendler quickly establishes that almost everyone would agree that the interests of nonhuman primates do have a moral significance we should respect, and the difference in opinion is simply a matter of degree.
From this starting point Wendler delineates one general principle: “individuals who are unable to consent should be enrolled in nonbeneficial research only when, at the very least, there is sufficient reason to believe that the potential benefits of the research justify the risks it poses.” To this, he adds five related considerations:
“(1) It is frequently unclear (to us) to what extent a given study poses risks/harms to nonhuman primates; (2) The chances that any given nonbeneficial study with nonhuman primates ultimately will benefit humans (even in combination with other studies) is uncertain and likely low; (3) Uncertainty regarding the comparative moral status of humans and nonhuman primates makes it especially difficult to determine what level of potential benefits for humans is necessary to justify a given level of risk/ harm to nonhuman primates; (4) Nonbeneficial research involves investigators acting as the proximate cause of the risks subjects face and the harms they experience; (5) In general, no justification has been identified for enrolling individuals who cannot consent in nonbeneficial research to benefit others.”
With these criteria established, Wendler stresses his opinion that even though we may agree that nonhuman primates have at least some morally relevant interests, we have “no way” to estimate what kind of interests they have, or how relevant they are, to us. Indeed, though the questions are highly subjective, Wendler wades into some rather strange territory saying that we have “limited epistemological access” to the experience of nonhuman primates. So, for example, a human researching another nonconsenting human may “have a general sense for how much of a burden it is for humans to undergo a lumbar puncture,” while at the same time he says that “given our limited epistemological access to the experiences of nonhuman primates, reviewers must assess the impact of research interventions by appeal to proxy measures, such as blood pressure, facial expression, body posture, and information on how the research in question would affect humans.” This is a strange fissure in Wendler’s logic: he states there is research that would obviously be too painful to be morally acceptable to perform on nonhuman primates, but seems unwilling to acknowledge that we may be able to use common sense to deduce what is painful and unacceptable in general, rather than use a series of measurements to quantify exactly how painful something is.
From this fissure in Wendler’s thinking, however, he does offer an interesting possibility for subjects who cannot consent to still offer “assent” or “dissent” in different ways: “Allowing individuals who do not have sufficient capacity to consent, but who can nonetheless express their preferences, to decide what happens to them can protect their interests in two ways. First, even individuals who cannot consent often are in the best position to judge how a given experience or activity affects them. Children who cannot consent can indicate that a given procedure is causing them pain. Second, many individuals prefer to decide what happens to them. In this regard, a recent Institute of Medicine report on research with chimpanzees states that behavioral and biomedical research should be conducted only on acquiescent animals.” Though it is likely that many animal advocates would think that keeping animals in captivity for research, only to have them assent or dissent to particular studies, would not be truly respecting their interests, this is as far as Wendler is willing to go in his conclusions.
Original 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?