One of the peculiar legacies of unethical human experimentation is an impulse to protect people from perceived research risks, even when that means interfering with the ability of potential participants to exercise their own wills. Fears about the possibility of exploitation and other harms have resulted in a system of research oversight that in some cases prevents people from even having the option to enroll in certain studies because the research appears inherently risky.
Despite the fact that one of the central (some would say, the most important) principles of ethical human research is “respect for persons,” (shorthand: autonomy), our current regulations– and the institutions that enforce them– paradoxically promote an approach to research gate-keeping which emphasizes the prevention of potential harm at the expense of individual freedom. As a result, research activities often are treated as perils from which unsuspecting recruits should be shielded, either because the recruits themselves are perceived as too vulnerable to make reasoned choices about participation, or based on the premise that no person of sound mind should want to do whatever is proposed.
One example of such liberty-diminishing overprotection is the notion that study participants should not be paid very much for their time or discomfort because to provide ample compensation might constitute undue inducement. Although there is no explicit regulatory prohibition against compensating research participants for their service, The Common Rule requires researchers to “seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.” This has been interpreted by many to mean that payment for study participation cannot be offered in amounts greater than a symbolic thank you gesture and bus fare.
Research review boards should not be blamed for this interpretation. Federal guidance on this topic advises, “The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration.” This is a very low bar so it is not unreasonable to infer that anything more than a token payment might be perceived as an ethical violation.
The problem with this approach to compensation is two-fold: it is paternalistic and it treats research differently. The charge of paternalism is straightforward and has been made before. If you provide the opportunity for truly informed consent, respect for persons should be taken to mean the individual of sound mind gets to decide for him/herself about whether to participate and what amount of money seems reasonable for doing so.
Research exceptionalism compounds paternalism in the sense that it causes us to behave paternalistically in an inconsistent way. Adults of sound mind are trusted to accept payment for all sorts of other activities outside of the research context that might be considered risky, problematic, or embarrassing. We allow adults to engage in paying jobs that are dangerous (soldiers), dirty (plumbers), and socially stigmatizing (strippers). We let them donate blood and sperm for cash. We permit them to appear as “actors” on reality tv programs.
It is time to rethink whether research participants also should be able to earn compensation that is commensurate with the hassle, time off from work, and risk they undertake. If we truly value research participation as an honorable and important service, we should not be afraid to offer fair payment to those who volunteer. A failure to do so, out of fear of undue inducement, results in an unintended and unjust consequence: that research participation primarily will be an altruistic leisure activity disproportionately practiced by people who are so privileged they have no need to be compensated fairly.
Hi Sue – As you know, I totally agree with the idea that most of the restrictions on subject payment are crazy. But your concluding sentence surprised me: “A failure to do so, out of fear of undue inducement, results in an unintended and unjust consequence: that research participation primarily will be an altruistic leisure activity disproportionately practiced by people who are so privileged they have no need to be compensated fairly.” I thought you would end that sentence by suggesting the unjust consequence is for research participation to be disproportionately practiced by people who are so poorly off that they are willing to accept even unfair compensation. Don’t you think that is more likely?
You raise a fair point. It’s possible that people who are truly desperate will settle for token payments. However, I think the restrictions on subject compensation have made research particpiation seem not worthwhile for many working class and poor people who can’t afford to spend so much time and hassle for such meager rewards. Studies show that there is significant social inequality (and here I mean that white, middle class, educated men are disproportionately represented) in biomedical research due to all sorts of structural barriers: lack of interpreters, appointments offered only during normal working hours, lack of transportation and childcare, failure to engage with minority community leadership to improve recruitment, etc. I worry that the exclusion of certain groups from clinical trials, for example, puts some segments of the population at greater health risk because the results of safety and efficacy studies are not broadly generalizeable.