The latter might include free health services unrelated to the research, medical insurance, educational materials, or other benefits. Franklin Miller and Howard Brody explain: [W]hen physicians of integrity practice medicine, physicians and patients interests converge. This unfairly targets subjects of lower socioeconomic groups and places more of the risk burden of medical research on these groups. Undue Inducement as Coercive Offers. Offers of payment made to research participants6 have been described as one of the more contentious ethical problems facing institutional review boards (IRBs).7 The U.S. federal regulations and the leading international codes of research ethics require that consent to participation in research be obtained in a manner that minimizes the possibility of coercion and undue influence (a term used interchangeably with undue inducement). Joffe Steven, Cook E Francis, Cleary Paul D, Clark Jeffrey W, Weeks Jane C. Quality of Informed Consent in Cancer Clinical Trials: A Cross-Sectional Survey. Yet, even some who accept a role for offers of payment continue to emphasize the importance of preserving altruistic motivation. Jehovahs Witnesses, Why Dont Jehovahs Witnesses Accept Blood Transfusions?, Largent Emily A, Lynch Holly Fernandez. In addition, participants must be appropriately compensated for the time spent and other inconveniences resulting from study participation although explicitly not for risk that participants agree to undertake and payment amounts should be calculated using the minimum hourly wage in the trial location. Third, the policies generally allowed advertisements to indicate that payment would be offered, as long as undue emphasis was not placed on the offer of payment.253 A typical policy stated, [A]dvertisements may state that Human Subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.254 None of the polices we reviewed expressly forbade inclusion of payment nor did they require that offers of payment be explicitly mentioned in the advertising materials. We argue for adoption of our preferred definitions, ideally by regulatory authorities, and against the conventional conservatism toward payment of research participants. Employing that level of specificity will limit the extent to which individuals talk past each other and allow the conversation to be focused on the ethical concern at hand. 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. Private accommodation. Protection of Human Subjects. As Part II established, regulations and guidelines regarding offers of payment to research participants generally establish as the default that such offers are to be subjected to scrutiny because they may be unduly influential, coercive, or both, and so might undermine the validity of research participants informed consent. Additionally, although we do not think offers of payment are a panacea for recruitment problems, greater incentives may have the dual benefit of improving enrollment and drawing a more diverse pool of research participants. Ending Concerns About Undue Inducement. In short, the answer is not much. Compensating Research Participants: A Survey 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. Moreover, as clinical research progresses through the different phases, there will be a substantial accretion of data; therefore, uncertainty should dissipate over time. Public trust is essential to secure funding and institutional support for research and to recruit human subjects.174 Therefore, the argument goes, research exceptionalism is justified if it promotes and preserves the public trust. Resolving this question about which status quo baseline is the proper one to focus on under the rights-violating view can be the source of reasonable debate. Ethics of Paying Payment of participants in research: information for researchers, Offers of payment, even extremely high ones, should not generally be cause for ethical concern. First, we briefly describe the U.S. federal regulations and relevant guidance documents governing human subjects research from both the Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). While there is no physical force or external psychological pressure, there is considerable internal attraction because of the quantity or type of the incentive. This is consistent with the findings presented in. 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. Beecher Henry K. Ethics and Clinical Research. Research exceptionalism is the view that biomedical research is meaningfully different from other contexts in which individuals assume risk. Grady Christine. In other instances, they expressed concern about something that is not a legitimate ethical concern at all, but called it by an ethically charged name. Holly Fernandez Lynch, Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School. Glynn Simone A, Williams Alan E, Nass Catherine C, Bethel James, Kessler Debra, Scott Edward P, Fridey Joy, Kleinman Steven H, Schreiber George B. Attitudes Toward Blood Donation Incentives in the United States: Implications for Donor Recruitment. 1, Grady 2005; Ripley EB. Moreover, offers of payment span the spectrum of studies from those that pose minimal risk to participants to those that are far riskier and more burdensome. Borzekowski Dina LG, Rickert Vaughn I, Ipp Lisa, Fortenberry J Dennis. Thus, investigators were more likely to get it right in our view. Most commentators, however, have focused on the conditions under which offers of payment can be ethical, suggesting that research participation does not have to be exclusively or even primarily altruistically motivated. Pearson Steven D, Miller Franklin G, Emanuel Ezekiel J. Medicares Requirement for Research Participation as a Condition of Coverage: Is it Ethical? If you are a current caffeine and alcohol drinker 21-35 years of age, you may be eligible to participate in a research study examining the effects of music and memory on Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 76 Fed. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health. 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. The pervasive nature of risk is acknowledged in the Common Rule, which defines minimal risk research in terms of risks ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.139 Even granting that some research studies are riskier than the risks we ordinarily assume in daily life, [i]t is not clear that research per se is specifically risky.140 Therefore, the risk of harm does not itself justify research exceptionalism. Researchers will need to consider additional ethics concerns or issues arising from working with potentially vulnerable people. 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. The first article notes concerns Cambridge University Press & Assessment 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 practice of offering payment to individuals in exchange for their participation in clinical research is widespread and longstanding. In addition to a review of institutional policies, we conducted pilot surveys of individuals at Harvard Catalyst-affiliated research institutions in order to develop preliminary data about attitudes of both IRB members and investigators regarding payment generally, and about their beliefs regarding coercion and undue inducement in particular. With respect to the first option, although some ethicists defend the no-reasonable-alternative view of coercion, we indicated above why this approach is inconsistent with understandings of what counts as coercive outside of the research context, and why it must be rejected as an instance of inappropriate research exceptionalism. In general, the [IRB] does not allow dollar values to be specified., All advertisements should be tastefully composed and not inappropriately emphasize monetary remuneration., Advertisements may state that Human Subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type., It is sometimes desirable to provide payments to subjects and their families for their participation in research projects., It is not necessary, required, or desirable that all subjects involved in clinical research receive monetary compensation for their participation., The IRB must determine that the following requirements are satisfied before it approves research: There are appropriate additional safeguards included in the study to protect the rights and welfare of participants who are likely to be vulnerable to coercion or undue influence., The IRB shall review both the amount of payment and the proposed method and timing of disbursement to determine that neither are coercive nor present undue influence., The IRB reviews remuneration plans to assess whether the amount, schedule and type of any proposed compensation is fair for the participant, and to assess whether the payments could be considered coercive (i.e., by unduly inducing individuals to participate because compensation would difficult to refuse., Payment to research subjects for participation in studies is considered compensation for time and inconvenience rather than a benefit to subjects., In general, remuneration should be comparable to other projects involving similar time, effort, and inconvenience., Payment(s) shall be made to the subject as the study progresses and, In general, remuneration [s]hould be pro-rated based on the number of procedures and study visits and should not be conditioned on completing the entire study, although a bonus for completing the study may be acceptable., Any amount paid as a bonus for completion must be reasonable and not so large as to unduly induce participants to stay in the study who otherwise would have withdrawn., [A] timetable for the payments themselves must be presented to every subject as part of the Informed Consent process., In general, remuneration [s]pecifics (including the amount per visit and payment schedule) should be documented in the consent form under the Compensation sectionbut not under the Benefits section., Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount of be paid, by such means as larger or bold type and compensation information should be added towards the bottom of the advertisement., Recruitment materials should not emphasize remuneration for participation (e.g., larger or bold type)., Remuneration ordinarily offered as a form of appreciation for the individuals time and effort in the research project, The [IRB] is required to review payments to subjects to determine that: The amount of payment and the proposed method and timing of disbursement is neither coercive or presents undue influence., Under Federal regulations, the [IRB] must review and approve methods used to recruit subjects to ensure that the methods are not coercive., PIs are responsible to: Ensure the informed consent process is free from coercion or undue influence., The [IRB] is required to review payments to subjects to determine that: Credit for payment accrued as the study progresses is not contingent upon the subject completing the entire study., Indicate how much subjects will receive for each portion of the study completed and the payment form (e.g., cash, check, gift card). Reform of Clinical Research Regulations, Finally. In research, unlike in other activities, the argument goes, there is tension between the individual good and the public good because risk is assumed for the benefit of others, and so additional scrutiny is needed. Neither term is defined. Second, turning to an instance in which payment changes hands, it is unlikely anyone would say an individual had been coerced to take an unpleasant, risky (but perfectly legal) job if that was his best or even only option to earn sufficient funds to cover his bills. Office of Human Research Protections, U.S. Dept of Health & Human Servs., About OHRP. It is worth noting that the authors resisted drawing a bright line between that which is a mere inducement (i.e., ethically acceptable) and that which is undue (i.e., ethically unacceptable), instead emphasizing the contextual nature of undue inducements. In 1900, renowned American military surgeon Walter Reed paid study participants $100 in US gold to allow themselves to be bitten by infected mosquitoes in The draft surveys were pretested with IRB members, administrators, and investigators who were asked to comment on the content and design of the survey. 2010; Ryska 2015). At a minimum, this guidance should clarifyby stating explicitly rather than leaving it for the reader to inferthat genuine offers of payment are never coercive and reflect the empirical evidence suggesting that undue inducement is rare. The CUHS asked us to change how we asked questions about age between the two studies, which is why the results are reported differently. Elsewhere within the FAQs, overt coercion is defined as e.g., threatening loss of services or access to programs to which the potential subjects are otherwise entitled. Office of Human Research Protections, U.S. Dept of Health & Human Servs.. Payment to Research SubjectsInformation Sheet. Existing frameworks for evaluating the ethics of paying research participants offer a strong foundation for assessing the acceptability of payment in COVID-19 trials. 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. This may be a threshold concern as to whether payment can be offered at alland not just the amount of payment. For the reasons outlined above, we maintain that each of these arguments fails. Track Payment Incentives to Participate in Research Participants That is what we turn to next. Both conditions are necessary.184. Your scale is precise because it said that the box weighed 7.5 pounds each time, but your scale is not accurate because 7.5 pounds is not close to the known value of 10 pounds. There is, as we have shown, an unfortunate divergence between the ideal and reality. 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. Coerced Participation in Clinical Trials: Conscripting Human Research Subjects. Undue Inducements and Reasonable Risks: Will the Dismal Science Lead to Dismal Research Ethics. Paying research participants: the outsized influence of undue influence. With respect to undue inducement, the FAQ observes that it is often difficult for IRBs to draw a bright line delimiting undue influence because it is highly contextual.93. sharing sensitive information, make sure youre on a federal No clear consensus has materialized regarding what these concepts mean, but we review the dominant themes and arguments that have emerged. In November 2009, representatives from HHS and other departments convened to draft the first substantive reforms to the Common Rule since it was published in 1991; these representatives had the dual aims of enhancing research participant protections and increasing the efficiency of the research oversight process.282 Their meetings led to the release of an Advanced Notice of Proposed Rulemaking (ANPRM) entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators in July 2011.283 The ANPRM did not substantively address payment, coercion, or undue inducement. NEJM From McGregors perspective, the prohibition against undue inducements is intended to guard against taking advantage of vulnerable populations, including impoverished persons with few, if any, alternatives.221 Note the similarity of this position to the view of coercion as simply having no reasonable alternative. While these are preliminary findings, and we call for more research, our data contribute to the growing empirical literature showing that confusion exists among IRB members regarding how to define the terms coercion and undue inducement.12 Our pilot survey is the first to examine how investigators define those terms; it is unsurprising but valuable to see that investigators are confused in much the same way that IRB members are. Statistical significance by chi-square test was defined as p < 0.05. The authors argue that payment of research participants is ethically unacceptable. WebPaying Research Participants. Because the FAQs provide guidance that represents OHRPs current thinking on these topics,84 they offer helpful insight, though they should [merely] be viewed as recommendations, unless specific regulatory requirements are cited.85. Additionally, consider the job of commercial fishing a risky occupation that exists to satisfy consumer demand for fish; the social benefit is mere satisfaction of consumers taste for fish. Halpern Scott D, Ubel Peter A, Berlin Jesse A, Asch David A. Randomized Trial of $5 Versus $10 Monetary Incentives, Envelope Size, and Candy to Increase Physician Response Rates to Mailed Questionnaires. Treatment of payment within these regulations and guidelines is highly uneven: some fail altogether to address offers of payment, while others address the purpose, amount, mechanism, and timing of offers of payment, albeit in a fairly high-level way. The ethical anatomy of payment for research participants OHRPs website addresses a number of Frequently Asked Questions (FAQs) about human subjects research, including questions regarding offers of payment. A paid advertisement relating to psychologists' activities must be identified or clearly recognizable as such. pay WebPaying Clinical Research Participants: One Institutions Research Ethics Committees Perspective. Noah Lars. Wertheimer Alan, Miller Franklin G. Payment for Research Participation: a Coercive Offer? Additionally, we encourage efforts to reform international research guidelines pertaining to payment. Whats the Price of a Research Subject? It is perhaps most worrisome that more than half of the respondents (58.9%) agreed that research participants are unduly influenced if the offer of payment makes them participate in research they would not otherwise participate in. WebResearch Participants. The New England Journal of Medicine 378/8 (2018). The other conditions are too vague to be useful or are clearly not necessary conditions.219. Again, consider police officers. Dunn Laura B, Gordon Nora E. Improving Informed Consent and Enhancing Recruitment for Research by Understanding Economic Behavior. Klitzman Robert. Office of Human Research Protections, U.S. Dept of Health & Human Servs.. The authors break down the process of researching with children and young people into ten stages, each with its own set of Paying Participants The appropriateness of compensation is likely better judged by local research ethics committees than by international ones. 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. 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. The themes arising from their comments are similar to those that have been raised by ethicists and suggest that recognising the time and effort of participants should receive greater emphasis than presently occurs. Given that the harms from overpayment are generally overstated, and the harms from underpayment are understated or even ignored, we advocate changing the default rules so that offers of payment will be deemed acceptable unless someone can articulate a clear (i.e., precise) and persuasiveas opposed to speculativereason why it is not. Of the 694 emailed invitations to participate in the IRB survey, 116 surveys were completed, for a response rate of 16.7%.258 Of the 1,596 emailed invitations to participate in the investigator survey, 115 surveys were completed, for a response rate of 7.2%.259. In this section, we present preliminary research that illustrates precisely such confusion and an emphasis on protecting subjects from payments that are deemed to be too high. The purpose of this case study is to show that the challenges identified herein are not just theoretical, but can have concrete effects in practice. Advertising: Disclosure of Participant Payment Part II surveys regulations and guidelines on the ethics of biomedical research at two levels: national and international. Some countries have adopted these as regulatory requirements, while in other places, they are merely advisory. Human Research Thacker determined that higher levels of payment increase willingness to participate, but, perhaps counterintuitively, there was no association between monetary payment and perceived risk.226 Finally, Eleanor Singer and Mick Couper conducted an online vignette-based survey and concluded that while larger incentives induced greater overall participation, respondents do not appear to exchange higher incentives for greater risks.227 Although more data are needed, these studies do not indicate that higher payment necessarily or even frequently leads to cognitive distortion regarding the risks of research participation. The ethics of payments to research participants | 3ie More Details Emerge on Fateful French Drug Trial. WebThe concept of redress evolved into a system in which subjects were offered money as an inducement to participate in research, sometimes merely to offset the monetary costs of participation, but sometimes even to mitigate the risks of the study.
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