pros and cons of paying research participants
Paying research participants | The BMJ In the face of disagreement among ethicists about what each of these concepts mean, it seems unrealisticat least in the absence of a definitive statement from OHRP or FDA, which we discuss belowto ask that IRB members and investigators universally accept one meaning as factually correct. As a result, IRBs and investigators bear significant responsibility both for determining what the terms coercion and undue influence mean in the context of offers of payment and for correctly identifying and addressing those ethical concerns when they see them. Yet, we agree with James Wilson and David Hunter that, [t]hese cases do provide prima facie evidence that unregulated research can be abused. Such payments may not be given for assuming increased risk., Both the informed consent discussion and the written informed consent form and any other written information to be provided to participants should include explanations of the following The anticipated prorated payment, if any, to the participant for participating in the trial., The consent form must describe the terms of payment and the conditions under which subjects would receive partial payment or no payment (e.g., if they withdraw from the study before their participation is completed)., The informed consent document should mention the possibility of tax withholding, when appropriate., The [IRB] will review advertisements to ensure that they do not unduly emphasize the amount subjects receive in compensation., Payment to research subjects may be an incentive for participation or a way to reimburse a subject for travel and other expenses incurred due to participation. Many understand both coercion and undue inducement to compromise voluntariness,28 whereas others argue that coercion compromises voluntariness while undue inducement chiefly compromises comprehension.29, The potential effect of offers of payment on research participants has been described as either coercive, unduly influential, or both, and therefore potentially problematic in terms of satisfying the ethical (and legal) requirement for valid informed consent. Commonly Performed Procedures in Clinical Research: A Benchmark for Payment. While there is no physical force or external psychological pressure, there is considerable internal attraction because of the quantity or type of the incentive. One might respond that a fire fighter who rushes into a burning building to save someone offers an immediate benefit, whereas participation in research saves lives over a much longer time-scale. Emanuel writes that [i]nducements prompt ethical concern when they distort peoples judgment, encouraging them to engage in activities that contravene their interests because they are harmful.209 Thus, his account is superior to the excessive-reward view because it clearly articulates the widely held concern that an undue inducement creates a cognitive distortion that impacts the validity of consent to enroll.210 It also provides additional criteria that more comprehensively articulate what is wrong about undue inducement. In reviewing these policies, we observed several trends relevant to our present discussion. Therefore, we propose that OHRP update its FAQs and that the FDA update its Information Sheet on payment to research participants, at least as a first step. One consequence of changing the default to generally accept offers of payment is that some offers of payment that are ethically concerning might get throughyet, we expect that this is only a slight possibility. Significantly, we do not claim that these arguments have failed to identify characteristics of research that might merit regulatory attention; indeed, we favor robust regulatory protections for human subjects research, including IRB review. This was an exploratory study without a nationally representative sample and with a low response rate, which imposes limits on the conclusions we can draw. Of course, there may be exceptions, such as in emergency research. There are thirty-one participating institutions. We argue for our preferred definitions of coercion and undue inducement and show that some definitions necessarily fail with the rejection of research exceptionalism. , If a subject withdraws before the conclusion of the experiment, payment must be pro-rated., Incentive or bonus payments may be appropriate under certain circumstances to encourage completion of experiments. Obvious exceptions would be surrogacy and sex work. Bennette Caroline S, Ramset Scott D, McDermott Cara L, Carlson Josh J, Basu Anirban, Veenstra David L. Predicting Low Accrual in the National Cancer Institutes Cooperative Group Clinical Trials. HHS Vulnerability Disclosure, Help The first principle is: The voluntary consent of the human subject is absolutely essential. The Code goes on to specify that [t]his means that the person involved should be able to exercise free power of choice, without the intervention of any element of coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.110 Coercion is not defined, however. To the extent that IRBs and investigators are identifying legitimate ethical concerns about payment, such conservatism is appropriately protective of research participants. Undue inducement and coercion are often said to be conflated,264 a claim consistent with our findings. The want of meaningful guidance at both the U.S. and international levels may help to explain the heterogeneity of offers of payment described in the preceding section, as well as the conservative approaches to payment we see both anecdotally69 and in many institutional policies, as described in Part V. In what follows, we outline the various definitions of coercion and undue inducement offered in these regulations and guidelines, but we refrain from normative evaluation until Part IV because the shortcomings of these definitions are most evident when facilitated by the discussion of research exceptionalism provided in Part III. You may feel like you're playing a more active role in your health. Largent Emily A. Whats Trust Got to Do with It? The FDA has not adopted the Common Rule, but applies essentially the same standards to all clinical investigations of products regulated by FDA involving human subjects, regardless of funding source.78. Yale J Health Policy Law Ethics. This is consistent with the findings presented in. There is, however, general consensus that coercion and undue inducement render consent invalid, though the mechanism by which they do so remains open to debate. In other words, simply asking if the threat would cause harm inappropriately identifies coercion in scenarios in which harm is justifiable (e.g., when an investigator threatens to remove a subject from a potentially beneficial clinical trial for failure to comply with the study procedures), and might fail to identify coercion when harm is arguably not present, but there is an obligation to make one better off. As explained in detail in our other scholarship, we think that participation in research is most appropriately analogized to labor; relevant comparators include police work and military service, jobs that are important to the community but also offer personal benefit.141 There is little normative debate about whether it is acceptable to offer payment, or higher payment, to people who accept risky jobs. Presidential Commission for the Study of Bioethical Issues (PCSBI). Although data are limited, payment is offered to participants in many research studies with amounts ranging from a few dollars to several thousands of dollars. Research Participant Incentives: The Pros and Cons of Gift Cards On the one hand, OHRP acknowledges that [p]aying research subjects in exchange for their participation is a common and, in general, acceptable practice.86 On the other, it cautions that despite, or perhaps because of, the lack of clear-cut standards on the boundaries of inappropriate and appropriate forms of influence, investigators and IRBs must be vigilant about minimizing the possibility of coercion and undue influence.87 Although more research is needed, one might infer that a call to be vigilant from an important oversight bodyone with a variety of enforcement mechanisms available to it, including institution-wide suspension of researchcoupled with limited substantive guidance on how best to offer payment to research participants could lead to extreme caution and support expansive understandings of coercion and undue inducement. In all, six institutions had no policy governing offers of payment to research participants, whereas 13 IRBs (covering the remainder of the participating institutions) did have a payment-specific policy or policies.245 Of those with policies, there is a great deal of heterogeneity: whereas some largely parrot the regulations, others go into much more extensive detail. However, A has an obligation to help B achieve something superior to the status quo at present, which is why we find coercion under the rights-violating view when we may not under the worse-off view. It is, therefore, unsurprising that investigators and Institutional Review Boards (IRBs) experience confusion about how to evaluate offers of payment, and lean toward conservative approaches. Two possible practical implications of crowding out altruistic motivations among research participants in favor of financial motivations are more troubling, and could potentially justify greater scrutiny of offers of payment in the research context than elsewhere. Nonetheless, because an IRB is approving a protocol for a general population, and not evaluating the circumstances of individual participants, we suggest that it remains possible that in some cases, an individuals particular circumstances might make his or her participation in an approved study unreasonable, i.e., the result of bad judgment. We would strongly advocate for our preferred definitions. What Makes Clinical Research Ethical? Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.116 Additionally, the IRB should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. Emanuel Ezekiel J, Wendler David, Grady Christine. Faculty, Center for Bioethics, Harvard Medical School. If individuals nonetheless choose to participate, restricting payment could also cause research participants to feel they have been treated unfairly as a result of inadequate compensation. Obviously, a threat may be veiled such that it appears to be an offer (e.g., I will refrain from shooting you if you give me your money.). More concretely, variation can be explained by the constraints established by study budgets and desires to avoid certain paperwork, tax reporting, or other requirements that are triggered when payments exceed a certain threshold.67, Considered together, these figures suggest that the offer of payment made to participants in the French experiment discussed at the beginning of this paper is on the higher end of the spectrum, but certainly not off the charts.68. The paper deals with the widespread practice of paying research participants in exchange for their valuable service without determining whether the service should be treated as an unskilled labor, "regular" work, body renting, or a unique sui generis endeavor (cf. It is, therefore, unsurprising that the space inhabited by IRB members and investigators is characterized by confusion and conservatism. Pearson Steven D, Miller Franklin G, Emanuel Ezekiel J. Medicares Requirement for Research Participation as a Condition of Coverage: Is it Ethical? As we have discussed in the preceding sections, despite a general consensus that coercion and undue inducement are to be avoided, there is a lack of clear regulatory guidance about what constitutes an acceptable offer of payment and disagreement about when offers of payment to research participants violate ethical norms. This is an empirical claim that deserves further examination. Whats in a name? Importantly, neither the worse-off view nor the rights-violating view of coercion falls prey to research exceptionalism, since they both reflect common views of coercion applied outside of the context of research as well. Paying People to Participate in Research: Why Not? The Current State of Subject Payment in Adolescent Research. In the field of science, accuracy tells us how close a measurement is to the true value. It is an unfortunate consequence of research exceptionalism to frame these offers as undue inducements, and it would be unacceptably paternalistic to protect competent research participants from their fully voluntary and rational undertakings. Do All Material Incentives for Pro-Social Activities Backfire? This means you can get a larger sample size for your study. Stone Judy. Because there is general agreement that coercion and undue inducement are wrong in human subjects research, such a charge can shut down conversation among IRB members and investigators, and result in rejection of an offer of payment, or failure to make an offer in the first place. If we do not think that morally problematic coercion occurs in these circumstances, it would be unjustifiable research exceptionalism to argue that it occurs when research participants believein the absence of any threatthat they have no reasonable alternative but to participate in research due to an offer of payment. Reg. Transparency of Participant Incentives in HIV Research. This unfairly targets subjects of lower socioeconomic groups and places more of the risk burden of medical research on these groups. Beyond these demographics, however, we will generally present the results for investigators and IRB members together because there were few instances in which the differences in their answers reached statistical significance; where the difference was statistically significant, we have included a footnote indicating that to be the case. Indeed, Jerry Menikoff, Director of OHRP, suggested at a recent public meeting that OHRP is not particularly worried about payment resulting in undue inducement, which he believesas we doto be rare.288 This perspective indicates that clarifying OHRP guidance on this topic would potentially be feasible, with the salutary effect of rendering IRBs less worried about enforcement actions should they approve higher payments. PAUL McNEILL. The former sets a default that is much more favorable to offers of payment than the latter, and also seems to be more in line with approaches to payment that might be expected outside of the research context, whereas the latter appears to be influenced by research exceptionalism. Third, the incentive does not just make the person do something they are not otherwise induced to do. McGregor Joan L. Free Markets, Bargaining Power, and the Rules of Exchange. This is the first survey to assess how investigators, as opposed to IRB members alone, define these terms. Investigators reported submitting an average of 14 (20) protocols to their current IRB. The [IRB] recognizes that varying amounts and methods of remuneration may be appropriate depending on the particular circumstances of a protocol., There are no established policies as to the amount of payments that may be offered., [A] list of approximate monetary compensations for a variety of frequently performed clinical activities is listed below. Research participant versus research subject. Research incentives help: Attract high-quality, committed participants Capture harder-to-reach or more mobile populations Philosophical Reflections on Experimenting with Human Subjects. Biascommonly understood to be any influence that provides a distortion in the results of a study ( Polit & Beck, 2014 )is a term drawn from the quantitative research paradigm. One policy states, for instance: Payment should not be coercive.250 Another explains, When subjects are being paid, the [IRB] will review both the amount of payment and the proposed method and timing of disbursement to assure that neither is coercive.251 A third states, The IRB reviews remuneration plans to assess whether the amount, schedule and type of any proposed compensation could be considered coercive.252 As we have stressed above, genuine offers of payment are never coercive because they do not threaten to violate an individuals rights but instead expand an individuals options. Each time, the scale says that the box weighs 7.5 pounds. Oftentimes, market research seeks feedback from specific types of people. Undue inducement requires the action entail a substantial risk of serious harm That is, there must be a risk of a serious adverse effect for the person. Bials Clinical Trial in France Ends in Disaster. Payable to family in the event of death. Gordon Bruce G, Brown Joseph, Kratochvil Christopher, Prentice Ernest D. In: Probstfield Jeffrey L, Frye Robert L. Strategies for Recruitment and Retention of Participants in Clinical Trials. In short, the answer is not much. For example, one respondent explained: Recruiting through Craigslist or other online methods seems to draw a lot of people who are unduly influenced by the compensation, to the point that they will lie about their medical history. Another stated, Professional subjects are very problematic for us.
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pros and cons of paying research participants
