problems with paying research participants

Largent Emily A, Grady Christine, Miller Franklin G, Wertheimer Allan. 2009; Rhodes 2010; London et al. It's not often I'm drawn to comment on a BMJ article, but the BMJ piece titled "Misrepresentation, coercion and undue influence: the dangers of paying research participants" (BMJ 2023;380:p686 . There was constant discussion about what level of compensation we could approve before it became coercive, says Devlin, former research program manager at Temple University. The worry is that if people can make more money in research than they can make in other activities, then money may be an undue inducement, Fernandez Lynch says. (Journal of Medical Ethics2000;26:126-130) The principle of justice provides a strong ethical reason for not offering recompenses for lost wages (or loss of other reasonably expected profits). After all, even small payment is better than no payment at all, although it constitutes a (mutually beneficial and consensual) exploitation. 2018). Before The principle of individual beneficence is rarely invoked in the discussion on ethical payment practices. The term recompense stands for any payment that entails no net benefit to recipients. Gul Raisa B, Ali Parveen A. Guinea pigs on the payroll: The ethics of paying research subjects. Keep in mind that we are all reasonably influenced by money every day, Fernandez Lynch says. Why shouldnt they be paid for that? Fernandez Lynch asks. Half of the members of the experimental groups were told that receiving an influenza vaccine within the last six months was required for eligibility, and half were told that not receiving the vaccination was required. Elliott Carl, Abadie Roberto. by Douglas MacKay 7 min read on paying money to research subjects. Thus, researchers must neither exploit the vulnerable, in particular economically disadvantaged, nor exclude without good reason those who stand to benefit from study participation. Study sponsors, investigators and institutions have financial or professional interests that often run contrary to the interests of subjects. Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information. Paid to endure: Paid research participation, passivity, and the goods of work. Therefore, there are no ethical grounds (either paternalistic or non-paternalistic) for depriving competent individuals an opportunity to serve as research subjects in exchange for money, provided that their decision to participate in a given study is autonomous (i.e., based on comprehensive and adequately understood information, and free from unduly controlling influences). Even if we assume that an IRB has carefully reviewed the study and determined that the risks are reasonable in relation to the benefits, we could still say that this monetary offer could constitute undue influence if it causes subjects to naturally consider money to be a benefit and therefore take risks that they would otherwise not consider to be reasonable. Without full understanding of the ethical anatomy of payment, it is impossible to determine what we owe, if anything, to research subjectswhat for, and how much research participants should be paid. Indeed, since most people regard money as beneficial, proposing to pay someone to do something constitutes an offer to benefit that person, not to harm them (Wertheimer and Miller 2008; Resnik 2015a). Should healthy volunteers in clinical trials be paid according to risk? trials, alternative billing arrangements or group and site discounts please call Australian guidelines on Payment of participation in research: information for researchers, HRECs and other ethics review bodies issued by the National Health and Medical Research Council (2019) divide payment for participants in four analytical categories: reimbursement for any research-related expenses; compensation for any documented financial losses resulting from participation in research, including loss of wages, or from an injury suffered as a direct consequence of participation; remuneration paid to participants in recognition of their service for the time spent and other inconveniences resulting from participation; and incentive or inducement provided to individuals simply to encourage their enrolment or continuation in research. A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. 2018; cf. Federal government websites often end in .gov or .mil. Before It does not represent the views of the NIEHS, NIH, or US government. The most plausible justification for this viewpoint is that human subjects need these special protections to overcome the legacy of past abuses and promote the publics trust in the research enterprise. 22) for offering payment to research participants is to boost recruitment and retention rates. Largent, Emanuel and Lynch claim that when goods and services are not indented as gifts, failure to pay for them is a problem: we call it theft (2019, p. 1), thus suggesting that this is exactly what happens when participants are not fairly paid for their contribution to the common good. While the evidence concerning deception by research subjects is cause for concern, only one study has examined the relationship between deception and financial compensation for study participation. For example, the CIOMS Guidelines expressis verbis state that the level of compensation should not be related to the level of risk that participants agree to undertake (2016, Commentary on Guideline 13). U.S. Code of Federal Regulations, Title 45: Public Welfare, Part 46: Protection of human subjects. Moreover, as studies already referred to suggest (Unger et al. Paying Research Participants: The Outsized Influence of "Undue Bioethicists and institutional review boards often worry that paying human subjects too much money for research participation might compromise informed consent by coercing or unduly influencing individuals to enroll in studies against their better judgment. This efficiency-driven (Phillips 2011a) rationale is widely acknowledged. 2017. Remuneration is equitable when it does not violate the norm equal pay for equal work (Dickert and Grady 1999; Resnik 2015; Gelinas et al. Only a few, however, mention the level of research risks among factors which should be taken into consideration when determining an adequate amount of payment. Ethical rationale for paying research participants. Payment for participation in research: a pursuit for the poor? 2019). Finally, what is rarely observed, the principle of respect for autonomy provides a general support for public policies which allow remuneration of research subjects for their contributionsboth in the form of reward and priceas it calls for respecting peoples right to decide freely in what practices and activates they what to engage in for the sake of earning their living. Surprisingly, these questions have been rarely the subject of in-depth discussions in the literature. What other ethical principles and values shape the payment practice, and how? J Law Med Ethics. Many scholars worry that payment may be more attractive to individuals of lower SES, and thus offering payment for participation may result in unfair distribution of research benefits and burdens across the general population (e.g., Maclin 1981, 1989; Faden and Beauchamp 1986; Ackerman 1989; McNeill 1997; Grady 2005; Dickert and Grady 2008; Gelinas et al. A response to Wilkinson and Moore, Does incentivising pill-taking crowd out risk-information processing? The ambiguity undermines the conceptual and normative value of highly popular payment scheme advocated by Gelinas, Largent, Lynch, and collaborators (Gelinas et al. Participants 21 315 participants . The site is secure. government site. Bioethicists and institutional review boards (IRBs) often worry that paying human subjects too much money for research participation might compromise informed consent by coercing or unduly influencing individuals to enroll in studies against their better judgment (Grady 2001, 2005; Klitzman 2013, 2015; Largent et al. 2004; Resnik 2018). None of the foregoing discussion suggests that bioethicists and IRB members should not be concerned about the potential for effects of financial compensation on research subjects decision-making and behavior. I have no conflict of interests or competing interests to disclose. Most of the criticism of the trial has focused on the unsafe dosing procedures, not on the payments to the participants (Resnik 2018). The latter value necessary depends on various factors, including (i) time allotted to research; (ii) efforts or types of services rendered (e.g., performing psychological or physical tests, taking drugs or using device as instructed, conducting self-monitoring or gathering other research-relevant information); (iii) discomfort, burdens or inconveniences associated with participation (e.g., stress, pain, suffering, but also burdens related to sticking to a dietary regime or inconveniences caused by the expected lifestyle changes); (iv) the level of risk involved in research, and (v) special/unique value of the input of the specific subject (e.g. There are also problems with this justification. 64). 1.1). J Clin Res Best Pract. Equally, there is no common view on what constitutes an ethical source of this purported obligation or acceptability of payment (as such or of a certain kind), and which ethical reasons lie behind different payment categories and schemes. Either scenario could invalidate the study results. It is commonly accepted that the principle of justice requires distributing burdens and benefits of study participation in such a way that no segment of the population is unduly burdened by research or denied its potential or actual benefits. For example, in the movie Indecent Proposal, a financially struggling married couple encounter a billionaire at a casino in Las Vegas, Nevada, who offers them one million dollars if the woman will spend a night with him and have sex. National Library of Medicine When this happens, study participants might be exposed to unreasonable risks. Interested in Group Sales? As a library, NLM provides access to scientific literature. Macklin Ruth. The lure of money might cause some people, especially those who are socioeconomically disadvantaged, to take unreasonable risks for financial gain (Macklin 1981; McNeill 1997) or to lie to investigators about important health information to qualify for enrollment (Dresser 2013). Bethesda, MD 20894, Web Policies See this image and copyright information in PMC. IRB oversight of research is paternalistic in that it protects people from taking risks deemed by the IRB to be unreasonable. Bentley John P, Thacker Paul G. The influence of risk and monetary payment on the research participation decision making process. It argues that researchers have a prima facie moral obligation to offer payment to research subjects, which stems from the principle of social beneficence. the contents by NLM or the National Institutes of Health. Numerous authors and guidelines suggest that the amount should be based on the minimum hourly wage in the region or country as a point of reference (Council for International Organizations of Medical Sciences 2016, Commentary to Guideline 15, 53; National Health and Medical Research Council 2019, Appendix 1, 7) with augmentations for particularly burdensome procedures (Ackerman 1989; Dickert and Grady 1999; Grady 2005; Gelinas et al. Likewise, one might view policies that give IRBs authority over payments to research subjects as paternalistic insofar as they limit the economic freedom of the subjects to obtain higher amounts. The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentives. The remaining ethical principles constitute a skeleton of morally sound payment practices by providing additional moral reasons for offering or not offering certain types of payments to research participants. Research enterprise should not entrench or exacerbate these background social injustices. That can perhaps be improved by offering even more payment so that participation becomes more attractive to a wider variety of people, Fernandez Lynch suggests. A history and theory of informed consent. Miller Franklin G, Brody Howard. Recruitment and retention of participants are both critical for the success of trials, yet both remain significant problems. This site needs JavaScript to work properly. Page, Emily Haozous, Angelica Solares, Carla N. Cordova, and Richard S. Larson. Following Christine Gradys terminology (2005), the authors separate reimbursement, compensation, and incentive. 22). Phillips, Trisha. HHS Vulnerability Disclosure, Help History provides ample evidence of the potential for exploitation in research with human subjects. Finally, the advocated typology allows for separating payments form small gifts given at the conclusion of a study (such as chocolates, T-shirts, cups, pens, cinema-tickets) that have minimal market value, serve only as token of appreciation, and have likely zero impact on recruitment (Grady 2005).
Scout Inspirational Quotes, Dr Vincent Leone Southington, Articles P