pros and cons of paying research participants{ keyword }

A notable fissure in the literature relates to whether genuine offers, rather than threats, can ever be coercive.192 One of the most visible advocates of the view that offers can be coercive is Ruth Macklin.193 In a 1989 article, she noted that the reason for holding that it is ethically inappropriate to pay patients to be research subjects is that [offers of payment are] likely to be coercive.194 Joan McGregor more explicitly links the concept of coercive offers to the no-reasonable-alternative view just discussed. Precision, by contrast, refers to the closeness of two or more measurements to each other.270 Unfortunately, our data suggests that currently when IRB members and investigators define and use the terms coercion and undue inducement, they are often neither accurate nor precise. For instance, a handful (5%) of respondents to the IRB survey explicitly stated that they were not certain how to define undue influence in answer to a free response question. The authors of the Belmont Report clearly understood coercion and undue inducement as distinct concepts, but it is implied that both affect the voluntariness of consent. Yet, even some who accept a role for offers of payment continue to emphasize the importance of preserving altruistic motivation. This list is meant to guide investigators, and is based upon active protocols currently approved by the [IRB]. As a result, we fear that IRBs sometimes incorrectly reject offers of payment that really ought to be ethically acceptable, thereby eliminating a potentially important tool in clinical trial recruitment. A direct benefit to research participants is a benefit that arises from receiving the intervention being studied, as opposed to other types of so-called collateral benefits that may be associated with trial participation, such as access to specialists and more attentive care.36, There is a common perception that money is offered only to healthy subjects in research, and rarely to patient-subjects with the disease or condition under study.37 Relatedly, commentators sometimes assume (or argue) that while it is legitimate to offer payment to healthy volunteers for their participation in research, one should not offer to pay patient volunteers, at least when they stand to accrue other benefits from research participation.38 Others, however, have persuasively argued that there is no inherent reason to treat healthy volunteers and patient volunteers differently with respect to payment.39 Data suggest that, in practice, researchers do in fact nearly always offer payment to healthy research participants, and also increasingly offer payment to patients who participate in clinical research, even when the study holds the prospect of direct medical benefit.40, Investigators may be motivated to offer payment to research participants for a number of reasons, and the perceived ethical acceptability of these reasons varies greatly.41 Given the lack of clear regulatory guidance, one would fully expect the space inhabited by IRBs and investigators to be characterized by confusion and a general trend toward conservative approaches to offers of paymentbetter to be safe than sorry in the midst of uncertainty. Yet, even if one continues to defend research exceptionalism with regard to payment, it is possible to endorse our preferred definitions on the grounds of their superior explanatory power and consistency with the canon of non-surplusage. We argue for adoption of our preferred definitions, ideally by regulatory authorities, and against the conventional conservatism toward payment of research participants. 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. Alan Wertheimer, Exploitation 2223 (1996). The Pros and Cons of Online Survey Research - Provoke Insights Another argument for research exceptionalism stems from the now substantial evidence that many who participate in research suffer from the therapeutic misconceptionthat is, they confuse the goals of clinical research (social benefit) with the goals of clinical care (individual benefit)and, at least some individuals may be unaware that they are participating in research at all.154 More generally, some people may assume the risks of research participation despite a failure to fully comprehend them. In contrast, those in favour of paying research participants argue that payment rightly recognizes the contribution individuals make to research outcomes and that without such financial recognition the number of participants opting to be involved in research would be insufficient to achieve statistically robust results; payment is viewed as a . If we allow payment for those jobsand we dothen the optional nature of social benefit, if true, could not justify research exceptionalism with respect to payment. 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. Moral Science: Protecting Participants in Human Subjects Research. Therefore, public trustwhile doubtlessly important to the research enterpriseis not an acceptable argument for research exceptionalism, particularly with regard to payment. For the reasons outlined above, we maintain that each of these arguments fails. Alan Wertheimer182 and Franklin Miller offer a view of coercion that is similarbut not identicalto that of the Belmont Report.183 On their rights-violating view of coercion, A coerces B to do X in a way that invalidates Bs consent only if (1) A proposes or threatens to violate Bs rights or not fulfill an obligation to B if B chooses not do X and (2) B has no reasonable alternative but to accept As proposal. These results are encouraging in the sense that they indicate that most respondents include the correct (by our analysis) definitions of coercion in their understanding of the term. 46.102(f) (2015). Although many individuals implicitly endorse the idea that research is different, we suggest that nine common justifications for research exceptionalism ultimately fail, at least when it comes to offers of payment. Paying research participants: a study of current practices in Australia Misconceptions About Coercion and Undue Influence: Reflections on the Views of IRB Members. Gelinas et al. DOI: 10.1177/1747016115626756 participants be ultimately self-defeating? Hall Ali. 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. Additionally, there is a lack of agreement regarding what exactly the terms coercion and undue inducement mean in the human subjects research context. If offering payment dilutes altruistic motivation, this might (1) reduce the overall pool of prospective research participants, i.e., some altruists may not participate at all if payment is offered because they find the offer repugnant, and/or (2) selectively appeal to individuals who are somehow less desirable as research participants due to their motivation by payment.172 While a number of experimental studies have examined the effects of financial incentives on altruistic motivations in other contexts, particularly blood donation, and generally found results consistent with the crowing out hypothesis,173 data is needed about research participation in particular. Research Associate, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School; Regulatory Foundations, Ethics, and Law Program, Harvard Catalyst | The Harvard Clinical and Translational Science Center; Research Associate, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School. Participation as Commodity, Participation as Gift. The current research literature on the practice of paying participants and the impact of payment on participants and study integrity are reviewed. Online Market Research Panels: What Are The Pros and Cons? See Table 2. Some individuals chose the same definitions for both coercion and undue inducement. In other words, B is presently untreated and would continue to be untreated if B refuses to capitulate to As demand, so Bs status quo is unchanged and B is, at least in a sense, not made any worse off. The way payment will be prorated should be specified.117 Unlike the OHRP FAQs but like the FDA information sheet on payment, the GCP guidelines suggest that payments can be both coercive and unduly influential. Of course, what constitutes a disproportionate offer may be subjective. Jennings Claudine G, MacDonald Thomas M, Wei Li, Brown Morris J, McConnachie Lewis, Mackenzie Isla S. Does Offering an Incentive Payment Improve Recruitment to Clinical Trials and Increase the Proportion of Socially Deprived Elderly Participants? The Pros and Cons of Taking Paid Surveys Paying Research Participants: The Outsized Influence of Undue Influence. While this divergence is neither unexpected nor blameworthy, the lack of clear institutional guidance, layered upon a lack of clear regulatory guidance, likely reinforces a tendency toward conservative approaches to payment among IRB members and investigators. Cons: 1. At What Price? Offers of payment made to research participants have been linked to both concepts, and yet the various laws, regulations, and ethical guidelines that govern the conduct of human subjects research offer relatively little in the way of specific guidance about what factors or features render offers of payment ethically acceptable, or notor even how to define coercion and undue inducement. For both terms, we will highlight areas of consensus, briefly review the range of definitions offered within the literature, and offer our preferred definitions. This is consistent with the findings presented in. Further, even when risky jobs are held by those with few other options for less risky work that is comparably compensated, the law does not require that their payment be restricted on that basis.143. This work was conducted with support from Harvard Catalyst | The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award UL1 TR001102) and financial contributions from Harvard University and its affiliated academic healthcare centers. Therefore, we will not define the terms here, instead reserving that discussion for later. 6. Remuneration for participation in research should be just and fair. Appelbaum Paul S, Lidz Charles W, Grisso Thomas. Are $350+ focus groups real? Emanuel Ezekiel J, Wendler David, Grady Christine. reimbursement for parking and/or your time will be provided). Yet, as Wilson and Hunter astutely point out, [W]hile research protocols may be difficult to understand, they are no more difficult and often considerably less difficult to understand than many official documents such as the fine print on mortgage documentation.156 Of course, the risks are not clearly analogous (e.g., physical v. financial), but as the housing crisis made clear, signing a mortgage without full comprehension can have devastating repercussions. Respondents Current Roles Related to Human Subjects Research. Next, we examine international guidelines, which are highly influential and may be formally (or even legally) applicable, depending on where research is conducted. This paper argues against paying people to participate in research. Shuster Evelyne. PAUL McNEILL. Bargaining Advantages and Coercion in the Market. Both types of participants may feel that they have no reasonable alternative, even though individuals always have the option not to participate in research as a regulatory matter. In total, CIOMS offers the most explicit guidance regarding offers of payment to research participants providing additional guidance regarding persons who are incapable of giving informed consent themselves, the timing of payment in relationship to early withdrawal, and the need for empirical study of financial incentives themselves. Wright Megan S, Robertson Christopher T. Heterogeneity in IRB Policies with Regard to Disclosures About Payment for Participation in Recruitment Materials. Do All Material Incentives for Pro-Social Activities Backfire? In these numbers, we again see evidence that IRB members and investigators often conflate undue influence and coercion. The Consent Substitute Model. 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. While it is beyond the scope of the present article to defend this proposition, we are of the opinion that it should generally be permissible to sell the bodily services of surrogacy and sex. This apparent distinction also proves illusory, however. Yet, as mentioned above, Harvard Catalyst encompasses institutions ranging from academic medical centers to community hospitals to schools of medicine and public health. It may be that people in these jobs deserve higher payments for a variety of reasonssuch as shift-work and specialized training or skillbut risk is among them. In contrast to the two prior definitions, this definition does not require a threat at all.

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