Posted on September 4, 2019 at 12:40 PM
This editorial is co-posted with the American Journal of Bioethics.
by Emily A. Largent JD, PhD, RN, Ezekiel J. Emanuel MD PhD, and Holly Fernandez Lynch JD MBE
Offers of payment made in exchange for research participation are common. And yet they are often regarded as, at best, a “necessary evil.” This is odd. In most nonresearch contexts, people find payment for goods and services unproblematic. Indeed, when goods and services are not intended as gifts, failure to pay for them is a problem; we call it theft. Why should payments made in the context of research participation be of particular ethical concern?
The target articles in this issue of AJOB point to two novel responses: research participation as unfulfilling work and coercion as subjection. The authors suggest that their concerns can be addressed by offering higher payments for research participation, an outcome we agree with. However, we do not share their ethical worries. It is ethically unproblematic for research participants not to share the goals of research, to be motivated to participate because they lack better options, and to view participation as work, even if it is unsatisfying.
TRADITIONAL CONCERNS ABOUT OFFERS OF PAYMENT FOR RESEARCH PARTICIPATION
A number of factors figure into the ongoing discomfort with payment in research exhibited by ethics reviewers, investigators, sponsors, regulators, and ethicists. Relevant laws, regulations, and ethical guidelines offer relatively little in the way of specific guidance about what counts as an ethically acceptable offer of payment, but consistently call for caution. Within the bioethics literature there is a lack of consensus on what constitutes ethical payment, with various concerns attributed to the conceptually difficult concepts of coercion, undue influence, exploitation, and commodification. Unfortunately, discussions of payment typically lack clarity about what these terms mean or how exactly payment engenders them.
Some ethicists worry that payment is “likely to be coercive” because it can create a strong pull to participate in research. However, most—including us—argue that by definition “genuine offers cannot coerce”, when coercion is understood to require a threat to make someone worse off by violating their rights or depriving them of something to which they are entitled.
Another concern is that payment can unduly influence decisions about research participation. Because inducements pervade everyday life, the challenge is to sort the acceptable from the unacceptable—or undue—ones. A mere influence encourages the offeree to do something that is reasonable but that he or she might otherwise choose not to do, while an undue influence is so excessive that it causes the offeree to do something unreasonably against his or her interests. Identifying undue inducements is difficult because they are highly contextual. The task is made easier in research, however, as well-functioning independent review should ensure that participation is reasonable for the target study population. If ethics review determines that research is reasonable without considering the benefit associated with any offer of payment (as required), then no amount of payment can make the research unreasonable. This means that no matter how high the payment for research participation, there is little reason to worry that payment will veer from mere to undue inducement.
Exploitation is sometimes confused with coercion or undue inducement, but it is a distinct concept that refers to one party taking unfair advantage of the other, consensually or nonconsensually. Exploitation depends on the fairness of the distribution of advantages and burdens from a transaction. Some worry that high offers of payment will take unfair advantage of economically worse-off populations, causing them to shoulder a disproportionate share of research burdens. However, the solution to exploitation concerns is to assure that payment and other benefits are high enough to fairly compensate for those burdens—not to insist on low or no payments.
Finally, some ethicists argue that “payment to … serve as research subjects is an ethically unacceptable commodification of research practice”. Individuals worried about commodification find it improper to offer money in this context, even if the validity of consent is not in doubt. Yet it is unclear why research participation should rely on altruism alone, when such self-sacrifice is not typically expected outside research settings. It should be “no more worrisome to commodify a person’s labor as a research subject than to commodify a person’s labor in other contexts, which happens all the time”.
NEW CONCERNS ABOUT PAYMENT
Discomfort with offers of payment for research participation stems from many sources and often reflects a misunderstanding of important concepts. This pair of target articles argues, however, that there may be legitimate reasons for concern that go beyond those commonly adduced. This line of inquiry is important, given that discomfort with the role of money in research persists despite ongoing efforts to defuse the common payment-related worries. Additional causes of discomfort should be critically examined and appropriately addressed, whether through refutation or through additional participant protections.
Malmqvist locates some of the discomfort in the fact that Phase I research participants are paid to passively endure having things done to them. This is problematic, he argues, because their passivity forecloses the possibility of achieving certain goods of work such as excellence, social contribution, community, and social recognition within the research context. In addition, he claims, the low level of payment prevents participants who view research as work from pursuing these goods outside the research context.
Millum and Garnett suggest that payment is coercive, but not in the way coercion has typically been understood. Their worry about payment is not that it undermines consent. Instead, they claim that offers of payment may give rise to “coercion as subjection.” That is, in some limited circumstances, payment causes participants to subordinate their own purposes to the purposes of researchers, purposes they do not share. This resultant loss of freedom may make participants worse off in important respects, even if their lives are better overall for having accepted money to participate.
Both articles worry that offers of payment in exchange for research participation can result in individuals doing or having degrading things done to them. Of course, if people do things that are humiliating or that result in a loss of self-respect in order to secure payment, that would be ethically concerning. Yet if there is a well-functioning system of research ethics oversight, there is little reason to be ethically concerned about paying for research participation.
RESEARCH PROTECTIONS AND ECONOMIC REALITIES
The authors collectively fail to acknowledge that research has an advantage over other circumstances in which payment may be offered. If ethics review boards fulfill their ethical and regulatory responsibilities when approving research projects, participants should not be viewed as degraded because their contributions to research will be necessary and socially valuable. Their acceptance of burdensome or even potentially embarrassing research tasks and procedures will not be ethically egregious, but rather compellingly justified by their relevance to important research questions. When research satisfies the social value requirement and when risks and burdens have been appropriately minimized, participation may in fact be a greater source of satisfaction and self-respect than many other occupations or activities. In other words, given the heightened and explicit scrutiny afforded to the ethics and practice of clinical research through independent ethics review, research participation seems likely to be a better job than many other jobs that may be available to participants.
If individuals are motivated to participate in research—in whole or in part—by money, that should not be problematic if the research is reasonable and does not pose excessive risks. Most people have no choice but to work for money to survive. Typically, we do not worry that workers’ freedom is inhibited if they accept reasonable employment. Moreover, we do not worry if they are primarily motivated by money rather than by a desire to advance some higher purpose or goals shared with their employer. Instead, we might say “that’s life”—and hope, much like Malmqvist, that they have adequate means to find freedom and meaning in other aspects of their lives, including their avocational interests, family, civic activities, religion, political engagement, recreation, and the like.
Given this reality of paid work, which is widely accepted as ethical, we disagree with Millum and Garnett when they suggest that offering payment for research participation can lead to a type of coercion. It may be true that the only way prospective participants in dire financial straits can avoid unacceptably bad outcomes is by engaging in paid research. But so long as researchers did not themselves eliminate other options that would have been available to participants, it is not the case that they helped “make it true” that research participation is the only acceptable option. As this is one of the central criteria for coercion as subjection as described by Millum and Garnett, all that is left is an offer in an unfortunate circumstance not created by the researchers, which starts to look more like a situation that could give rise to exploitation, not coercion. Even if participants would have preferred more or different offers, an offer of payment to participate in research (the goals of which they do not share) will not make them at all worse off. Instead, they are entirely better off for the offer having been made: They have avoided the miseries of poverty and have not taken unacceptably high risks. Indeed, research participation is lower risk than many other ways of avoiding dire financial straits—mining or enlisting in the military, for example.
PAYMENT AS THE SOLUTION
As a corollary to the necessary evil view, a frequent solution to professed discomfort with payment is to minimize or even eliminate payment to research participants. Yet contrary to this convention, both target articles contend that a key means of addressing the sources of discomfort they have identified is to increase payment amounts. This makes perfect sense when one properly understands the primary concerns described by both articles as concerns related to exploitation—exploitation of the participants’ lack of better, more fulfilling options. On Malmqvist’s account, paying more will provide a level of financial security for participants that can improve their opportunities for fulfillment outside of research participation. According to Millum and Garnett, ample remuneration can help offset the negative effect of having one’s will subjected to another’s. For them, payment can be both the problem and the solution; for us, it is all solution.
We agree with the conclusion that paying more is generally superior to paying less. Acknowledging research participation as a valuable service, including by offering substantial payment, is a way to demonstrate respect for participants even if we acknowledge that they may be “paid to endure.” And when participants are respected, they may take more pride in the work, potentially even adopting research goals as their own, much the way that adequately compensated employees working for socially interested companies often view their work as “more than a job.”
More broadly, reducing the amount of payment for participation in research is a poor means of resolving ethical discomfort. To the extent that discomfort reflects a misunderstanding of key concepts, it cannot justifiably constrain payment. Moreover, reducing payment is not without its downsides. Limiting payment entails perverse ethical and practical consequences. Offers of payment serve a number of important functions in research, including reimbursement of research-related expenses, compensation for time, effort, and inconvenience, and incentive to promote recruitment and retention. Thoughtfully designed offers of payment are powerful tools for treating participants fairly, reducing financial barriers to participation, promoting just distribution of the benefits and burdens of research, and speeding up the conduct of socially valuable research. In short, payment is not the evil people routinely make it out to be.
Focusing exclusively on ethical discomfort with payment is akin to treating a symptom while ignoring the underlying disease. Worries about payment are likely symptomatic of deeper worries about exploitation—using research participants for the benefit of future patients. A true cure requires going beyond questions regarding what constitutes ethical payment. Instead, we must strive to ensure that investigators design and that parties responsible for research oversight approve only those studies that are socially valuable, pose reasonable risks, and offer adequate benefits. If we are not confident that the current oversight system can reliably achieve this outcome, the problem runs much deeper than offers of payment. Then it would be problematic to offer opportunities for research participation at all, and questions of payment are moot. If, however, the system is structured to get it right the vast majority of the time, we should continue to use payment as the ethical tool that it is.
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