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Scholars, ethicists, and regulators generally agree that some form of compensation to participants in medical research is appropriate, but what constitutes “appropriate” is highly context-dependent, and opinions vary widely on the specifics. In practice, research oversight authorities and clinical trial sites are often left to their own devices when deciding compensation rates. Thus, compensation can be quite arbitrary across institutions, even for relatively similar studies (Grady et al. 2005; Grimwade et al. 2020).
In December 2023, 1Day Sooner co-hosted a parliamentary debate on the ethics of compensation for human research subjects with Effective Altruism DC and the George Washington University EA student group. A video of the event is available online. This post is a summary of the debate with additional commentary and notes from 1Day Sooner.
The topic debated was “Should high-risk, high-burden medical studies offer high payment to recruit volunteers?” The judges’ panel included experts in bioethics, public health, and clinical trials. Debaters ultimately focused less on the ethics of compensation for recruitment in high-risk, high-burden trials, but rather on the ethical acceptability of (high) compensation regardless of trial specifics.
The Government team argued in favor of high compensation in line with the topic question, and the Opposition against. The Government team featured Josh Morrison, founder of 1Day Sooner and a non-directed kidney donor (debates on organ donor compensation are similar to those on clinical trial compensation), and Maiya Little, an undergraduate majoring in political communications and disabilities studies at George Washington University and GW debate team member. The Opposition featured Jake Eberts, 1Day Sooner’s communications director and participant in two human challenge studies, and Elisa Reverman, a PhD candidate in philosophy at Georgetown University.
Note that the debaters were assigned sides and argued their position regardless of their personal beliefs. Statements from the debaters or judges should not be interpreted as necessarily representing the views of the institutions they work for or even their personal beliefs.
Outcome and Major Arguments
The winner of the debate was the Government, which held that high compensation was acceptable for any purpose provided the study was otherwise scientifically sound and approved by regulators and research ethics boards (and, by extension, high compensation in ethics oversight-/regulator-approved high-burden, high-risk trials, whether for recruitment purposes or otherwise, was acceptable). The judges voted 7–3 in favor of the Government. The audience was collectively given one vote, which went to the Opposition, bringing the final tally to 7–4.
Of all the arguments raised in the debate, four were especially salient.
Racial justice and equity: The Government argued that the status quo, which the Opposition defended, artificially suppresses payment for historically marginalized groups, especially people of color, who disproportionately take part in the riskiest and most burdensome forms of research (e.g., phase I drug studies). Thus any prohibition on payments for being “too high” is inherently regressive and self-defeating, because in the quest to “protect” participants, the status quo merely perpetuates existing injustice by ensuring that high-risk, high-burden studies are only economically viable for society’s least well-off.
Benefit to participants: The Government noted that in general, we assume that paying people more is a benefit to them, and thus that the default presumption must be that the Government position is better for participants unless the Opposition could show serious negative consequences from payment. (The Opposition discussed undue inducement as a potential harm, as explained later in this post, but this line of argument did not appear persuasive to most judges.)
Incentivizing deception: The Opposition’s argued that high compensation would lead to increased motivation for some participants to be deceptive about critical information such as their medical histories and adherence to trial protocols, resulting in heightened risk to participants themselves and to the scientific validity of a given study.
Market spiral: The Opposition argued that allowing unlimited compensation would price out smaller research enterprises and academic studies that did not have the budgets to sustain high compensation that large pharmaceutical companies might.
The rest of this writeup features a closer examination of the debate and 1Day Sooner’s commentary. The following text is arranged to be most legible, with some adjustments to order and phrasing compared to the literal words spoken in the debate round.
Arguments in Favor of High Compensation (Government)
Framing and scope
The Government in its opening speech stated that it would narrow the scope of its focus to healthy participants, e.g. phase I drug studies or human challenge studies. The Opposition implicitly accepted this framing and did not challenge it later in the round. (The wording of the resolution could be interpreted to include e.g. chemotherapy trials among cancer patients, which can be classified as high-risk and high-burden, but also entail the prospect of medical benefit to participants.)
The Government then defined the status quo: in the United States, ethics oversight bodies can reject compensation as too high, citing federal regulations on undue inducement (more on this concept below). This likely has a chilling effect at some institutions where oversight bodies are very concerned about high payment being coercive or unduly inducive; researchers might not request higher payment even if they personally think it is warranted. The Government advocated for a system in which high compensation would never be grounds for rejection of a study, which would include acceptance of high payment to incentivize enrollment in high-risk, high-burden studies.
The Government interpreted the topic to apply only to medical trials that otherwise obtain regulatory and ethical approval; it would not defend high compensation in any study that would be rejected as unethical for other reasons.
Respect for participant autonomy
The Government opened with two questions to frame the debate for the audience. The first had to do with participant autonomy: why must participation in medical research necessarily be treated completely differently from other types of engagements where risk is involved, such as employment in construction work?
The Government argued that we should, in general, defer to the judgments of individuals when they make assessments of what they want to consent to, just as we do when they make decisions about what sorts of jobs they take on. In other words, if someone wants to join an approved study solely to be paid, we should assume they have the right to make that decision for themselves (provided they otherwise pass through the informed consent process).
In anticipation of objections that participants in medical research may be more vulnerable than the idealized or average participant in an economic transaction, the Government maintained that this is all the more reason to pay more, not less. It is strange, after all, that ethicists and regulators don’t regulate the pay of the doctors or scientists running a given study but insist on doing so for participants. Ultimately, we should be aiming to benefit the people who are worse off or in a more vulnerable position (i.e., participants), and paying them money is the most straightforward way to do so.
In subsequent speeches, the Opposition argued that even though we generally recognize the right for individuals to consent to transactions as they please, there are still transactions that society has correctly restricted. For example, it is illegal to sell organs.
The Opposition also argued that it is not necessarily the case that individuals are the best judges of their self-interest in complex cases like medical research, which involve highly specialized knowledge. Moreover, high payment can conceivably alter participant’s rational ability to assess risk and undermine their ability to consent (see also the Opposition argument on undue influence later in the debate).
1Day Sooner’s view
While we believe the underlying reasoning from the Government is strong, the Opposition did not adequately exploit a weakness in the argument, which assumes a symmetry between trial participation and other careers. Intuitively, joining a clinical trial is not quite the same as partaking in an everyday job. McNeill 1997 argues that that risk assumed in research is a one-off event and is highly unpredictable, which is not true of normal careers and jobs, where risks are known and extensive preventative measures can be taken. This would mean compensation is much more ethically suspect.
On the other hand, one could argue participants are actually afforded more protection in some ways than those in other jobs via the IRB review process, which is supposed to ensure that the contract entered into by participants is not exploitative or excessively risky; McNeill seems to ignore this fact.
At the same time, however, research participants do lack protections than regularly employed individuals, who are subject to minimum wage laws (and crucially, not maximum wage laws) and, critically, worker’s compensation benefits in the case of injury. Fernandez Lynch 2014 explores this similarities and differences in greater depth and concludes — rightfully, we think — that we ought to “level up” legal protections of research participants to more closely match those that already exist in labor law, rather than try to suppress their pay.
Making participants better off
The second of the Government’s opening questions related to concrete benefits to research participants. The Government asked: how could it be that paying someone more actually makes them worse off, all else being equal?
In general, people will prefer to be paid more money rather than less, whether in a clinical trial or in any other context. This fact alone placed the burden of proof on the Opposition to show that paying more would be a harm to participants, because otherwise we must default to paying people more whenever we can. This burden is on the Opposition because the Opposition’s view is such an unusual way of thinking about compensation, which is not prevalent in any other part of the economy or society — no one would argue that paying construction workers less is better for them, for example, even though the work can be outright dangerous.
If the Opposition were to concede that the participants themselves are not harmed by higher payment per se, they must show why the harm that is underpayment is justified by other ethical benefits.
The Opposition held that even if individuals can be made better off by payments resulting from a certain transaction, that does not mean that the transaction itself was just or should have been offered. Thus, whether or not participants who do participate are better off is not relevant to whether or not the transaction is ethical or just.
The Government argued that this was non-responsive, as other parts of the debate dealt with the question of ethics. In effect, the Opposition had conceded that the Government was the only side in the debate whose position actively bettered outcomes for research participants by enabling higher payment.
Economic and racial justice
Racial and economic justice demand that we pay higher compensation than in the status quo, where compensation is limited not always by budgets but by paternalism and fear of undue influence. This is because those who are affected by such “ethical” wage suppression are disproportionately people of color, and in particular, disproportionately Black. In the Government’s view, it is deeply concerning that the harm of decreased compensation is mostly shouldered by historically marginalized groups as they undertake an activity that benefits all of society, but from which they do not directly benefit.
The Opposition’s response somewhat misinterpreted the argument. The Opposition characterized the Government as arguing that by raising compensation, intensive/burdensome research could diversify participant populations and avoid having to rely disproportionately on low-income participants or historically marginalized racial groups. (Note: Similar points are made in, e.g., Fernandez Lynch 2014, p. 160; and Anomaly & Savulescu 2019, p. 796 — limiting compensation, the argument goes, means participation in research is only feasible for those with lower opportunity costs and fewer economic alternatives.) The Opposition’s response to this argument was that there is no guarantee raising payments would solve for the worryingly disproportionate recruitment of marginalized groups in high-risk, high-burden research because there are other factors involved in well, such as work schedules.
The Government pointed out at the end of the debate that the Opposition had misunderstood the original argument and in doing so, moreover, the Opposition had admitted that the status quo involves a deeply concerning over-reliance on people of color and low-income people. The Government thus said that a vote for the Opposition meant a vote for the continued, artificial suppression of wages for vulnerable groups.
1Day Sooner’s view
Data on healthy participants as a group are not collected systematically, but research suggests that among participants in phase I healthy volunteer drug trials, Black and Hispanic men are indeed significantly overrepresented (see Fisher & Kalbaugh 2011, Fisher 2020, and Kalbaugh, Kalbaugh, McManus & Fisher 2021).
This represents a problem of distributive justice: it is unfair that the burden of participation in early phase medical research, which forms a core basis of medical advancement that benefits all of humanity, falls primarily on the shoulders of historically marginalized groups, who do not benefit from the medical advances. (And while participants in early-phase clinical research are not intended to be representative of the general population, there is a chance that inadequate diversity may raise scientific concerns as well.)
1Day Sooner believes that the de facto suppression of payment in the name of avoiding undue inducement is thus suspect from the outset because it is not only done on what we believe to be logically and empirically unsound bases, but also because it in practice has a disproportionate impact on historically marginalized racial groups, whom are left worse off than they otherwise would be.
Harm to research and medicine
The system of artificial, ethics-based limits on compensation likely delays recruitment in studies because it narrows the population for whom participation is economically viable. On the whole, this results in slower development of life-saving drugs and vaccines, which is immensely costly in terms of human life.
The Opposition criticized this argument as a utilitarian, “Silicon Valley” approach that prioritizes speed over ethics and quality, which is antithetical to the necessarily deliberate and cautious nature of medical research. The Opposition further noted that this sort of mindset is self-defeating, as marginal gains in speed realized by adopting this attitude can be completely wiped out when serious adverse events, like deaths, occur in clinical trials. Finally, insofar as the Opposition’s argument about deception was true (see below), gains in speed could be offset by decreases in quality of scientific research.
In its closing argument, the Government argued that the Opposition had failed to make any substantive argument against utilitarianism itself; calling an argument “utilitarian” did not constitute a rebuttal. Further, the Government maintained that at no point did it advocate for reduction in quality or other clinical trial regulations that would trigger the supposed negative outcomes outlined by the Opposition; rather, these outcomes were merely asserted as inevitable without explanation of connection to compensation. The Government elsewhere in the debate contested the deception argument, as noted later.
Arguments against High Compensation (Opposition)
Someone is unduly induced to participate in a study when they are offered excessively high payments that cause them to act against their better judgment and expose themselves to risks they otherwise would not consent to. All else being equal, higher payments make it harder to rationally assess the long-term impacts and risks of participation in medical research, which undermines the capacity for participants to truly provide informed consent. Thus, high payments are ethically fraught, and can be outright unethical, so there must be a norm against offering payments that are out of line with what is commonly offered elsewhere.
The Government argued that the alleged problem of undue inducement is so highly variable and amorphous that it is a useless frame of analysis. $10,000 is a lot to one person — and perhaps “unduly inducive” — but not to another person who makes far more money. This is also true of $1,000, or even $100. Thus, limiting payments don’t actually protect anyone except those who are already comparatively well off. At any point where you start paying people, the Government argued, you run the risk of causing undue inducement for at least some people who are very poor.
The Government then argued that the concept of undue inducement runs counter to how social and economic relations are structured in every other area of life. To adopt the Opposition’s view would be to say that things like hazard pay are unethical — that when people in certain jobs must do more risky things, they cannot be rewarded for it.
The Government also noted that there is little empirical basis for belief in the problem of undue inducement. In fact, the problem of risk assumptions may be exacerbated by artificially capping compensation — because society at large believes we ought to pay people more for riskier endeavors, people naturally interpret payments as a proxy signal for risk. By lowballing participants, you may be signaling to them the risk is lower than it actually is. (Note: There is some evidence to suggest that prospective participants pay closer attention to information offered about medical studies when the amount of payment offered is higher. See Cryder, London, Volpp & Loewenstein 2010.)
1Day Sooner’s View
The idea of undue inducement suppresses compensation from levels needed to ensure smooth and rapid recruitment by creating a culture of skepticism towards pay increases. We are aware of multiple accomplished research institutions conducting cutting-edge, potentially life-saving work that have failed to update payment schemes to inflation, which likely contributes to unnecessary delays in recruitment. The pervasive fear of undue inducement — which is so pervasive it bewilders even some regulators — also discourages investigators from even bothering to ask for increased compensation even when they believe it is ethically preferable.
Because undue influence is so nebulous, it also provides cover for organizations and researchers to underpay participants while framing it as “ethical”. There also seem to be significant cultural factors at play, as some research institutions appear wary to raise payment without signs from other institutions that they are doing the same, again out of a fear of undue inducement. Yet in developing nations, payments can be a sizable portion of the median GDP per capita without causing significant negative impacts on the individuals (see Njue et al. 2018, about a malaria challenge study in Kenya).
Risk of deception
Higher compensation would increase the motivation for some participants to be deceptive, which would undermine the integrity of the studies they enrolled in and potentially endanger the participants themselves. Deception could entail misrepresentation of one’s medical history or false statements about compliance with study protocols. The Opposition cited Fernandez Lynch et al. 2019, which showed an association between payment and willingness to lie in survey responses. (Note: the study showed that while offering payment correlated with greater rates of deception compared to offering no payment, offering greater amounts of money did not correspond to greater rates of deception, but this was not brought up by the Government.) Thus, even if there are benefits from faster recruitment as a result of higher compensation, the drawbacks to the integrity of data generated by research studies would be substantial, and likely render the Government’s proposal self-defeating.
The Government made two responses. The first admonished the Opposition for assuming the worst in participants and assuming that people are not able to rationally assess risk just because they are offered money. Second, the Government noted that even if deception is a possibility, studies rarely simply rely on the word of participants, and often take place in tightly choreographed and controlled settings with numerous objective tests to determine eligibility and risk profiles; many of these tests are functionally impossible to falsify. On the whole, then, the risk of deception is still low.
The Opposition countered by arguing that it is precisely because they assume participants are rational actors that deception may increase in response to higher payments, and that deception is a well-documented problem. The Opposition also noted there are only so many ways that
In its final speech the Government noted that the Opposition had failed to show how the deception problem was unique — other realms of economic activity involve deception, but the notion of payment limits to combat it is highly unusual.
1Day Sooner’s view
Like many judges, we believe this is one of the stronger arguments put forth by the Opposition and against high payment for research participation in general. Ultimately, however, we do not believe it is sufficient to warrant compensation ceilings across the board.
Deception among healthy participants is a longstanding issue that has been well documented in academic literature (Lee, Holmes, Neri & Kushida 2018; Devien et al. 2013). The problem arises whenever there is a significant motive to participate — including in trials involving non-healthy volunteers (i.e., something with the disease or condition being studied). Cancer patients, for example, may have a literal life-or-death stake in the outcome of their enrollment in a clinical trial, and so it is not surprising that there are attempts to game the system in such cases (McNair 2021). Nonetheless, oncology trials continue productively, suggesting the possibility of extreme inducements hardly renders research impossible.
More research is needed into the effects of compensation on proclivity for deception among participants. It may be that higher compensation necessitates more stringent screening measures in a protocol, for example, and in cases where deception would be exceptionally difficult to detect, lower payment may be warranted. Still, we run into the same problem as discussed above in the section on undue inducement: whatever acceptable low amount of money is offered will almost always represent a substantial sum to at least some people, so lowering payment does not make the problem does not go away, and lower payments may not substantially affect rates of deception, as the Fernandez Lynch et al. 2019 study suggests.
Negative impact on public trust
Public trust in research and medical institutions tanked in the aftermath of COVID. Excessively higher compensation for medical studies could engender a popular conception of people being lured into dangerous experiments for money, damaging public trust in medical and scientific research.
The Government argued that the Opposition’s conjecture about public trust could easily apply in reverse, that is, the public’s perception of medical research could be negatively affected by a perception of systematic underpayment in the status quo.
The Opposition did not return to this argument for the remainder of the debate.
By eliminating the norm against high payments, the Government’s advocacy will lead to crowding out of important studies conducted at less wealthy institutions, such as university research centers. The result will be that Big Pharma will throttle recruitment at non-Pharma sites. This is particularly concerning because pharmaceutical companies often focus on the most lucrative products, but these are often not the products that could prevent the most harm, whereas universities are more likely to pursue research in neglected diseases and those affecting less well-off people.
The Government replied that this argument runs counter to a basic understanding of economics. There is not a small, finite reserve of healthy participants — as the average payment to volunteers increases, it will attract more people from other sectors of the economy. The “pie” of participants would grow as it generally does for other economic sectors when aggregate wages increase.
1Day Sooner’s view
This argument from the Opposition is weak. As the Government correctly noted, recruitment is not a zero-sum game. Moreover, we believe that it is likely that this situation is already occurring; that is, pharmaceutical companies and contract research organizations appear to be offering higher payment than nearby academic institutions, even if trials at the latter are more demanding. This might be because the institutional review boards at academic institutions are much more likely to be concerned by undue influence and less worried about delays in recruitment timelines.
1Day Sooner was founded as a grassroots movement of people willing to join human challenge studies for COVID-19 to aid in the fight against the pandemic. Our advocacy work has expanded greatly since then, but we still consider our research participant-oriented work to be a core mission. Our view of compensation is informed by this concern for participants and conversations with them (including staff members who have participated in human challenge studies) as well as reviews of academic literature. The following is a small selection of the resources we found most informative in formulating our view thus far:
- Devlin 2020, Compensation in Medical Research
- Fernandez Lynch 2014, Human Research Subjects as Human Research Workers
- Fisher, McManus, Kalbaugh & Walker 2021, Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?
- Halpern et al. 2004, Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials
- Lamkin & Elliott 2018, Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation
- Largent & Fernandez Lynch 2017, Paying Research Participants: The Outsized Influence of “Undue Influence”
- Lee 2018, Our flawed approach to undue inducement in medical research
- Njue et al. 2018, Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya
- OHRP Exploratory Workshop 2022: Beyond altruism – Exploring payment for research participation