Carlisle Benjamin, Kimmelman Jonathan, Ramsay Tim, MacKinnon Nathalie. The best way to promote the rights and welfare of adult human research subjects is to treat them as autonomous agents who have the capacity to make wise choices involving money, and not like children or mentally disabled individuals who need to be protected from its influence. We look first at the ethics of paying research participants. 2018). Paying research subjects: participants' perspectives | Journal of Nipp Ryan D, Hong Kessely, Paskett Electra D. Overcoming barriers to clinical trial enrollment. Thats crazy: Community perspectives of financial compensation in clinical research. Second, even if bioethical qualms about the influence of money pertain only to high-risk research, these qualms would not be good reasons for applying special financial protections to human subjects, since there are many other high-risk occupations that people perform for money, such as firefighting, policing, coal mining, logging, roofing, steel working, race car driving, and boxing, which set no upper limits on payment (Resnik 2018). Roche Eric, King Romain, Mohan Helen M, Gavin Blanaid, McNicholas Fiona. Bierer Barbara E, White Sarah A, Gelinas Luke, Strauss David H. Fair payment and just benefits to enhance diversity in clinical research. Thus, societies have a prima facie moral obligation to promote the conduct of biomedical research, including research involving human subjects. Learn more, Reduce Risk of Long COVID Nightmare: Get Vaccinated, The Face of the ED Boarding Crisis Is a Childs. 2017, https://www.fda.gov/RegulatoryInformation/Guidances/ucm126429.htm?utm_campaign=FDA%20clarifies%20information%20about%20payment%20and%20reimbursement%20to%20research%20subject&utm_medium=email&utm_source=Eloqua. Disclaimer. 2019). 2023 Mar 27;13(1):21582440231160698. doi: 10.1177/21582440231160698. Should healthy volunteers in clinical trials be paid according to risk? Emanuel Ezekiel J. 2019; Lynch et al. Yet community members expressed the opposite view, according to the results of a recent study. However, the ethical concerns expressed by commentators and IRB members about the influence of money on research participation seem to apply to both high-risk and low-risk research alike. All guidelines and regulatory documents referred to above follow this normative logic by recommending or permitting paying research participants an appropriate or proportionate or just and fair remuneration for the time spent and other inconveniences resulting from the study participation (Council of Europe 2005b, sec. Second, even if bioethical qualms about the influence of money pertain only to research with a high potential for exploitation, these qualms would not be good reasons for applying special financial protections to research subjects, since there are many other occupations with a high potential of exploitation, such as agricultural work and factory work, which set no upper limits on payment (Resnik 2018). The reason being the fact that the consequentialistic principle of social beneficence does not exhaust the reining normative framework for human biomedical research. 1981;3(5):1-6. Many commentators argue that IRBs should carefully review payments to avoid the potential for coercion or undue influence (Dickert and Grady 2005, Grady 2005, Gelinas et al. Our All Access Subscription provides unlimited access to our entire publication Tishler Carl L, Bartholomae Suzanne. The ethics of biomedical research is built upon a matrix of principles and values which strives to find an adequate balance between the imperative to advance interests of science and society (research imperative) and obligations of all societies to protect other important interests of their members, especially interests of research participants and/or involved communities. [Google Scholar] 16. Payment is a recruitment incentive justified and prima facie required by social beneficence, not by justice or fairness. Research Participation as Work: Comparing the Perspectives of Respondents strongly believed study participants should be compensated because they take risks and give time. . 2012), but this way of thinking about the issue rests on a conceptual mistake. To restore and safeguard the publics trust, researchers should follow rules and norms for protecting the rights and welfare of human subjects that provide more protection than people ordinarily have outside the research context (Miller and Wertheimer 2007; Resnik 2015b, 2018). Why does paying people money for research participation seem ethically suspect to so many commentators and IRB members? 2021, p. 16). Kwiatkowski Kat, Coe Kathlyn, Bailar John C, Swanson Marie G. Inclusion of minorities and women in cancer clinical trials, a decade later: Have we improved? This is expressive verbis acknowledged by the U.S. Food and Drug Administration (2018) guidance which argues that payment to research subjects is a recruitment incentive and by the European Unions Clinical Trial Regulation (2014) which refers to any payment offered to trial participants as incentives or financial inducements (art. Insofar as these factual assumptions about inducing potential of money are trueand we concede them for the sake of the argumentthe principle of social beneficence provides fundamental ethical rationale for paying research subjects. King Reame Nancy Treating research subjects as unskilled wage earners: A risky business. Money might send a message to participants that they take risks and burdens for the sake of the benefit of science and society and should be compensated for it, which would not occur if they were expected to benefit from it. (Glannon 2006, p. 252; also Dickert and Grady 1999; Grady 2001, 2005; Menikoff 2001; Largent and Lynch 2017a). 2011. Second, the studies did not test for the effect of socioeconomic status (SES) on decision-making, although they did include participants from diverse educational and income levels. Andsince it sets the reference value of an non-exploitive remuneration relatively lowmore researchers could afford to pay a fair wage and fewer would be inconvenienced by a prohibition on unfairly low wages (Phillips 2011a, p. 219). Menikoff Jerry. 2017. Members of the public might be more concerned about the potential for exploitation arising from underpayment of human subjects rather the possibility of undue influence associated with overpayment. A framework for ethical payment to research participants. Accessibility THE ETHICS OF PAYING RESEARCH PARTICIPANTS. The usual justification offered for paying research subjects is that payment facilitates the timely recruitment of an adequate number and type of subject ().Payment may be important to research to the extent that it encourages participation. 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." Some forms of exploitation, such as slavery, involve all three elements, but exploitation can occur even when no harm occurs and the parties consent, when the distribution of benefits is unfair. We look first at the ethics of paying research participants. Increasing value and reducing waste in biomedical research regulation and management. National Library of Medicine One of the core values behind the imperative of non-exploitation in research is the value of human autonomy. Since individuals still play a key role in safeguarding their own welfare, it is important to ensure that their decision-making regarding research participation is not unduly influenced by money. 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. Bove R, Poole S, Cuneo R, Gupta S, Sabatino J Jr, Harms M, Cooper T, Rowles W, Miller N, Gomez R, Lincoln R, McPolin K, Powers K, Santaniello A, Renschen A, Bevan CJ, Gelfand JM, Goodin DS, Guo CY, Romeo AR, Hauser SL, Campbell Cree BA; UCSF MS-EPIC Team. 2020), risks involved (Menikoff 2001), and even other additional benefits (cf. 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. Vitamin D supplementation and major cardiovascular events: D-Health and transmitted securely. 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). Jones Eleri, Liddell Kathleen. 2019). 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." with no further explanation. 2012. Unauthorized use of these marks is strictly prohibited. The practice of offering payment to individuals in exchange for their participation in clinical research is widespread and longstanding. Paying Research Participants: Regulatory Uncertainty, Conceptual 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. Other ethical principles of research ethics (respect for autonomy, individual beneficence, and justice/fairness) make up an ethical skeleton of morally sound payment schemes by providing additional moral reasons for offering participants (1) recompense for reasonable expenses; and (2a) remuneration conceptualized as a reward for their valuable contribution, provided (i) it meets standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive (i.e., it does not constitute undue inducement for participation or retention, and does not encourage deceptive behaviors); or (2b) remuneration conceptualized as a market-driven price, provided (i) it is necessary and designed to help the study achieve its social and scientific goals, (ii) it does not reinforce wider social injustices and inequalities; (iii) it meets the requirement of non-exploitation; and (iv) it is not overly attractive. (PDF) Paying research subjects: participants' perspectives Nevertheless, it should not restrict peoples choices without a good reason. Infamous abuses of human research subjects, such as the Nazi experiments on concentration camp prisoners, the Tuskegee syphilis study, and the US governments secret radiation experiments, have involved exploitation. The first justification is that human subjects require special protections from the influence of money on judgment and decision-making because participating in research is generally riskier than other types of labor or human activity. I am grateful to Michael Fessler for helpful comments on the manuscript. 2018). 2010. Malmqvist Erik. Payable to family in the event of death. Since all liberal and democratic societies share a fundamental moral (and political) commitment to protecting and respecting each persons right to lead her life in accordance with her personal views of what is valuable in human life, they also share a moral obligation to encourage forms of social collaboration useful in fulfilling basic health needs of their members (London 2003, 2006; Rawls 1971; Nussbaum 2013). Devlin was inclined to agree that high payments were problematic. 2018; Lynch et al. If we reject Emanuels argument that monetary offers for research participation cannot cause people to take unreasonable risks, we should turn our focus to empirical questions related to the impact of financial incentives on judgment and decision-making. Salman, Rustam A. S. Elaine Beller, Jonathan Kagan, Elina Hemminki, Robert S. Phillips, Julian Savulescu, Malcolm Macleod, Janet Wisley, and Iain Chalmers. Although prominent international guidelines and national regulations call attention to the crucial moral issues that payment raises (in particular, the risk of undue influence), they offer little substantive guidance on how to pay research subjects in an ethical way, and if they do so, they often provide contradictory advice. 8600 Rockville Pike 2018; Persad et al. . 2018; Manton et al. eCollection 2023 Jan-Mar. 2019a; Largent and Lynch 2018; Bierer et al. Those who choose the path of deception might have a sound grasp of the risks of research, yet still act against their values by doing something (e.g., lying or withholding important information) that they would not otherwise do. The influence of risk and monetary payment on the research A second way that offering too much money for research participation could constitute an undue influence would be if it encourages some people to deceive investigators about their health history or other important information to qualify for enrollment. 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. Lemmens and Elliott 1999, 2001; King Reame 2001; Anderson and Weijer 2002; Elliott 2008; Abadie 2015; Phillips 2011b; Lynch 2014; Ryska 2018). (Journal of Medical Ethics2000;26:126-130) Ripley Elizabeth, Macrina Francis, Markowitz Monika, Gennings Chris. Why is it the case that concerns about undue influence have had a disproportionate impact on bioethical thinking about paying research subjects? In some situations, remuneration merits special scrutiny because the recipients might not have the capacity to make wise choices involving money, due to their age, mental disability, or socioeconomic circumstances. To estimate the prevalence of deception among professional research subjects, Devine et al. Elliott Carl, Abadie Roberto. doi: 10.1212/NXI.0000000000200070. ICH Harmonised Guideline Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2). Watson Judith M, Torgerson David J. On the contrary, no matter how payment is important and effective as an incentive for participation, not every amount, method and timing of payment is acceptable. However, little attention has been paid to that principle in the context of no-payment and underpayment. 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. 2018, 2020; Persad et al. In this article, I argue that our ethical qualms about the negative impact of money on decisions concerning research participation are largely unfounded and reflect more general concerns about the need to avoid repeating abuses of human subjects that occurred in the past. Macklin 1981) have adopted a similar view of the potential impact of money on informed consent for research participation. Chino Fumiko, Zafar S Yousuf. 2010; Fry et al., 2005). Admittedly, biomedical research enterprise does not aim at broadening the scope of subjects freedom or autonomy. It is, however, rarely recognized as having not only practical, but also an ethical facet. Guidance for institutional review boards and clinical investigators. For the sake of this analysis, I use all these terms interchangeably, as is frequently done in the literature. London, Alex J. 2018). 3.4; Council for International Organizations of Medical Sciences 2016, p. 53; Food and Drug Administration 2018; National Health and Medical Research Council 2019, par. Bioethical Issues in Providing Financial Incentives to Research Offering payment to clinical research subjects, in an effort to enhance recruitment by providing an incentive to take part or enabling subjects to participate without financial sacrifice, is a common yet uneven and contentious practice in the US. sharing sensitive information, make sure youre on a federal Most of the criticism of the trial has focused on the unsafe dosing procedures, not on the payments to the participants (Resnik 2018). Campbell, Marion K., Claire Snowdon, David Francis, Diana R. Elbourne, Alison M. McDonald, Resemary C. Knight, Vikki Entwistle, Jo Garcia, Ian Roberts, and STEPS Group. gifts, failure to pay f or them is a problem: we call it theft" (2019, p. 1), thus suggesting that this is exactly what happens . Most IRBs require investigators to provide them with enrollment data during continuing review of research, so they can ascertain whether studies are meeting their goals. 2019a, Unger et al. For DSR inquiries or complaints, please reach out to Wes Vaux, Data Privacy Officer, Lynch HF, Darton TC, Levy J, et al. Participants were randomized to receive information about a hypothetical study. http://etext.lib.virginia.edu/healthsci/reed/commission.html#vol How commonparticipants? Ryska Joanna. Health is highly valued by all individuals and societies primarily because of what it enables us to do (Duncan 2010, p. 321). Compensating for research risk: Permissible but not obligatory. 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. 2019. If risk is the main reason for worrying about the influence of money on research subjects, we should be concerned about paying people to participate in high-risk, non-beneficial studies and have few qualms about paying people to participate in low-risk studies. eCollection 2022. government site. 1979. Therefore, assumingwhat stills needs to be explored empiricallya positive correlation between the prevalence of deceptive behaviors and the attractiveness of payment (which depends not only on the amount, but also on payment method and timing), the principle of social beneficence provides ethical reasons for employing payment strategies which do not involve overly attractive payment schemes. Declaration of Helsinki. Fortaleza, Brazil. 2019). These mechanisms should enhance all stakeholders trust and willingness to support and invest in the research enterprise, including prospective research participants without whom biomedical research would not be able to achieve its goals. 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 . Moreover, in order to fully understand their consequences for ethics of paying research subjects, it is essential to note two things. One might argue that justice requires researchers to help people of low SES gain access to studies that offer potential benefits. 2008; Pasqualetti et al. 22) for offering payment to research participants is to boost recruitment and retention rates. 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. 3.1.2., 3.1.8., 3.1.9.) As a result, payment practices vary. Research ethics, Payment for research participants, Social beneficence, Autonomy, Justice/fairness, Undue inducement, Exploitation. The research subject as wage earner. While some ethicists (e.g. Several writers have argued that paying research subjects too little money could lead to exploitation (Shamoo and Resnik 2006; Resnik 2015; Largent and Fernandez Lynch 2017a, 2017b).
Why Is An Open House Party Illegal,
City Of Hobart Public Works,
Cities In Rockdale County, Ga,
Baldwin Homes For Rent,
Journey Church Fernandina Beach,
Articles P
