pros and cons of paying research participants

As a result, IRB members and investigators bear significant responsibility both for determining what the terms coercion and undue influence mean, how (if at all) they apply to offers of payment, and for correctly identifying and addressing those ethical concerns when they arise. Clinical Research: Benefits, Risks, and Safety | National Institute on 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. Resnik David B. Therefore, leveling the charge that an offer of payment is coercive or unduly influential should be the beginning, rather than the end, of the conversation. As part of this project, we reviewed payment-related policies for all of the IRBs affiliated with Harvard Catalyst. The conceptual definitions are highly variable, and as a result, different individuals reviewing an offer of payment may reach different conclusions in practice about whether that offer is coercive or unduly influential, and in turn, whether it is ethically permissible or impermissible. Justice for the Professional Guinea Pig. Paying Hypertension Research Subjects: Fair Compensation or Undue Inducement? Sponsors, researchers and Institutional Review Boards (IRBs) are . Such questions would, for example, have been useful to assess prospectively the offer of payment made to research participants in France. Transparency of Participant Incentives in HIV Research. From our perspective, that a majority of respondents would endorse these definitions demonstrates a widespread and fundamental misunderstanding of what coercion is. To the contrary, some studies indicate that offers of payment draw prospective research participants attention to risks (rather than causing risks to be ignored), while other studies have found no association between offers of payment and perceived research risk. Slomka Jacquelyn, McCurdy Sheryl, Ratliff Eric A, Timpson Sandra, Williams Mark L. Perceptions of Financial Payment for Research Participation among African-American Drug Users in HIV Studies. Online panels offer several advantages to market research buyers and suppliers including: 1. DOI: 10.1177/1747016115626756 participants be ultimately self-defeating? government site. Specify the payment schedule, including a prorated plan should a subject withdraw or be withdrawn from a study prior to his/her completion., The [IRB] is required to review payments to subjects to determine that: Any amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn., The IRB, when appropriate, will consider whether the following additional elements of informed consent are required and whether they are adequately included in the [informed consent document]: An explanation of the payment plan or a statement that subjects will not be paid for participation., Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type., In the consent process section, Describe any steps that will be taken to minimize the possibility of coercion or undue influence. 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. 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. Within many research institutions there is . Ezekiel Emanuel offers a four-part definition of undue inducements, of which a rewards excessiveness is only one feature: First, they entail an offer of a welcomed good, a positive incentive. While the Common Rule and its FDA equivalent cover most clinical research conducted in the United States,106 investigators and IRBs deliberations regarding what constitutes an acceptable offer of payment may also be influenced by a number of prominent ethical guidelines relating to the conduct of biomedical research. The induced person is getting something he or she deems desirable. For this reason, we compensate as little as possible, to decrease the number of these subjects that we enroll.. Revisiting Bias in Qualitative Research: Reflections on Its The majority agreed that research participants are unduly influenced if they participate as the result of intimidation, or some other form of pressure or force (60.6%)263 or if they are threatened with harm or loss of benefits to which they are otherwise entitled if they do not participate in research (55.8%),264 both of which are definitions applicable instead to coercion. In medicine, a false positive is an error where a result is improperly reported as positive when it actually is not. It is also evident as proven by other studies, that sending reminders to participants as well as using multiple. Research is, after all, intended to answer open questions regarding interventions about which knowledge is limited; therefore, [u]ncertainty is a fundamental characteristic of research.144 At the outset, it may be impossible to know with certainty the scope of potential or likely harmsas well as the potential benefitsfaced by research participants.145. 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. Yale J Health Policy Law Ethics. If society is willing to pay people to engage in risky but socially beneficial activities even when the benefits are arguably frivolous, as in the fishing example then consistency seems to require that they also be allowed to receive payments for participating in socially beneficial research involving serious risk.149 Thus, the argument that risk is assumed for the benefit of others in clinical research also fails to support the exceptional scrutiny given to research payments. As the preceding sections have highlighted, it is reasonable to expect that the lack of substantive guidance regarding offers of payment from key regulatory agencies and other influential bodies in research ethics, the misguided tendency toward research exceptionalism, and the want of clarity about how to define coercion and undue influence will result in conceptual confusion among IRBs and investigators, as well as a general trend toward conservative approaches to payment. The site is secure. Potential participants received an email embedded with an HTML link to the confidential, self-administered survey instrument, which was administered in Qualtrics, a web-based survey tool. We think it is fundamentally wrong to argue, as some have, that the need for large incentives can be a rough indicator that there may be an ethical concern that requires attention.273 People may simply wish to avoid the discomforts or burdens of research participation, and just as incentives are acceptable in other areas of life to override such reluctance, they are acceptable in the context of human subjects researchparticularly if one accepts, as we do, the role of a well-functioning IRB in determining that the risks of a study are reasonable in relation to the benefits, either to the individual or to society. Beyond these considerations, we believe it would be a mistake to accommodate erroneous beliefs that research is dramatically different from other potentially risky/uncertain endeavors, and instead favor attempts at education that build the right kinds of trust. Rather, a more tailored approach is appropriate, focused on those situations in which payment might have damaging instrumental effects, and also considering whether those effects might be avoided through mechanisms other than limiting payment. Part II surveys regulations and guidelines on the ethics of biomedical research at two levels: national and international. First, if an inducement is undue, it could prompt subjects to lie, deceive, or conceal information that, if known, would disqualify them as participants in a research project.200 This not only threatens to harm research participantsfor example, by exposing them to risks that the exclusion criteria were designed to shield them frombut also jeopardizes the scientific integrity of the research. Researchers Question Design of Fatal French Clinical Trial. 59 Citations 7 Altmetric Metrics Abstract Background There is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. Again, this seems more accurately to describe a mere inducement (i.e., something that one would not otherwise have done), not one that is undue per se, and is an expansive view potentially at odds with the pervasive use of offers of payment as an incentive for participation in research. Faculty, Center for Bioethics, Harvard Medical School. We grant that these concerns may be valid in some research contexts; however, they cannot justify restrictive approaches to payment in all instances. The advantages of this model could include minimization of the issue of undue inducement, reduced inter-study competition as seen in the market model that would also encourage investigators to minimize the risks involved, decreased financial sacrifice by the subjects and prevention of discrimination between high-income and low-income groups (lik. 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. Moreover, it should allow IRBs and investigatorstwo groups that have traditionally focused on whether offers of payment are too highto focus on the more ethically salient question: are research participants being paid enough? 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. Sixty medical research institutions are members of the CTSA Consortium, which is funded by the National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health (NIH). While we have argued above for the definitions that we think are best, we also recognize that reasonable disagreement is possible. 34 Sites for Paid Research Studies + Focus Groups - eBiz Facts If past experience is any guide, the research community will be working with the rule finalized in 2017 for some time (assuming it survives the political process and change in administrations), meaning that additional formal rulemaking specifically regarding payment is unlikely in the foreseeable future. paying research participants;conditions under which payment of research subjects would be acceptable,and the nature of acceptable recognition.Acceptable conditions were to improve problematic recruitment, to reimburse costs,and to recognise participants, particularly for their time investment.Both non-monetary and monetary recognition of Absent potentially serious adverse consequences of the bad judgment there is no undue inducement.206. Wadman Meredith. 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. Jehovahs Witnesses, Why Dont Jehovahs Witnesses Accept Blood Transfusions?, Largent Emily A, Lynch Holly Fernandez. Of course, there may be exceptions, such as in emergency research. Halpern Scott D, Karlawish Jason HT, Berlin Jesse A. 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. More Details Emerge on Fateful French Drug Trial. The commentary goes on to clarify that the obligation to reasonably reimburse and compensate participants arises even when participants otherwise stand to benefit from their participation.120, Recognizing the relevance of a studys risk level, the commentary notes that [e]specially when the research poses low risks, providing compensation should not raise concerns about undue inducement. This is notable among all the guidance discussed so far, as it is the only statement of a reason not to worry about payment in some contexts. Hall Ali. 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. For example, Emanuel, Wendler, and Grady state, [L]ocal traditions and economic conditions will influence when financial payments may constitute undue inducements.201 Wertheimer and Miller suggest that an individuals situation determines whether there is undue inducement; they emphasize that the distinction between an unproblematic inducement and an undue inducement is not a feature of the inducement itself. Inclusion in an NLM database does not imply endorsement of, or agreement with, Ending Concerns About Undue Inducement. Online Market Research Panels: What Are The Pros and Cons? While the respondents are professionally diverse and have considerable experience in human subjects research, they may have views that differ from others involved in the research enterprise, especially given that our results were generated exclusively from Harvard Catalyst-affiliated research institutions. Could providing financial incentives to research participants be Variation, then, may be the result, among other factors, of vague guidance regarding the appropriateness of payment or different understandings of how to value research participation or of the functions that payment serves. Cons: Costs, but most B2B recruiting will be at least somewhat costly. It is a function of the relation between the inducement and the subjects response to it.202 Ruth Grant and Jeremy Sugarman have written that [u]nder certain conditions, incentives are implicated in problems of manipulation in the form of undue influence.203 Finally, Ruth Macklin explored the question of how large a payment constitutes undue inducement and found it impossible to arrive at a single, objective criterion serving to mark off due from undue monetary inducements to participate in research.204. The Pros and Cons of Online Survey Research - Provoke Insights Download figure Open in new tab Download powerpoint Imagine you have a box that you know weighs exactly 10 pounds. Williams Rebecca J, Tse Tony, DiPiazza Katelyn, Zarin Deborah A. From our perspective, the larger concern is that subjects may be inadequately compensated for their contribution to socially beneficial research, which may slow recruitment, hinder retention, or exploit research participants who are not paid enough. 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. Another limitation to this exploratory data is that we asked about concepts only in the abstract, rather than including case studies. Research exceptionalism is the view that biomedical research is meaningfully different from other contexts in which individuals assume risk. It argues that many concerns about offers of payment to research participants can be attributed to the misguided view that such offers ought to be treated differently than offers of payment in other contexts, a form of "research exceptionalism." Working life often involves inducements and in particular sometimes involves inducements for engaging in risky working behavior (so-called danger money) . Grady Christine, Dickert Neal, Jawetz Tom, Gensler Gary, Emanuel Ezekiel. Yet, there is less uncertainty about research risks than it may appear, particularly as investigational products proceed through their development. Best International Sites Best Sites for the USA 30+ More Legit Sites Are paid research studies legit? Dunn Laura B, Gordon Nora E. Improving Informed Consent and Enhancing Recruitment for Research by Understanding Economic Behavior. 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. 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. Nevertheless, offers of payment to research participants remain the source of substantial debate. 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. Some commentators use this fact to argue that we should not allow people to make significant life choices without fully understanding the potential consequences for their lives.155. Nonetheless, it still leaves a considerable amount of discretion to the IRB to determine what constitutes an acceptable offer of payment. Unger Joseph M, Gralow Julie R, Albain Kathy S, Ramsey Scott D, Hershman Dawn L. Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study. Paying research participants: a study of current practices in Australia Paying research participants | The BMJ We emphasize that in the example for (2), Wertheimer and Miller say A does not propose to make B worse off than B is at present. In one FAQ, the following question is posed: What does it mean to minimize the possibility of coercion or undue influence?90 In response, OHRP provides definitions of coercion and undue inducement that largelythough incompletelyalign with those found in the Belmont Report, as well as examples. To fully appreciate the controversy engendered by offers of payment, it is necessary to consider them at a more granular level. The Investigator Survey was finalized after we had the results from the IRB Survey, and several additional changes were made to further enhance clarity.257. Emily A Largent, Research Associate, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School. However, the specifics of each protocol will influence how those determinations are made. Here, we will identify nine arguments made in favor of research exceptionalism, some with more force and frequency than others, and show that they all ultimately fail to justify the more stringent regulation of offers of payment made to research participants. The argument from uncertainty of risks does not necessarily or even obviously lead to the conclusion that offers of payment to research participants should be constrained, and so further justificatory work is needed to defend research exceptionalism with respect to payment. Additionally, we encourage efforts to reform international research guidelines pertaining to payment. Human subjects research is research in which human beings (as opposed to animals, atoms, or asteroids13) are the subjects of study. Additionally, the 2013 revision of Declaration states that [t]he protocol should include information regarding incentives for subjects and be submitted for consideration and approval to an IRB.112 The Declaration does not define coercion or undue inducement, nor does it raise these concerns in relation to offers of payment.113, The International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines are an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.114 They provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.115. Wertheimer and Miller state that the main point is that As proposal is coercive only if As declared unilateral plan[that is,] what A proposes to do if B does not do Xwould violate Bs rights.185 A classic example would be when a mugger pulls a knife on someone and says: Your money or your life. The mugger is threatening to kill his victim, which would violate the victims right not to be wantonly harmed by others, if the victim does not acquiesce to surrender his property. Therefore, public trustwhile doubtlessly important to the research enterpriseis not an acceptable argument for research exceptionalism, particularly with regard to payment. Paying participants can make them feel valued and appreciated for their time and effort. The ethics and implications of paying participants in qualitative research The Information Sheet acknowledges that [i]t is not uncommon for subjects to be paid for their participation in research, especially in the early phases of investigational drug, biologic or device development.100. First, and most notably, the vast majority of policies do not include definitions of either coercion or undue inducement, despite (or perhaps because of) the fact that these terms are not clearly defined in the U.S. federal regulations, nor are there broadly accepted definitions in the research ethics literature.
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