the ethical anatomy of payment for research participants
Such a concealment, fabrication or falsification by participants create risks for participants, but also for research resources and the integrity of research data as it can bias the results and undermine the validity of a study (Lee et al. 2009. For example, the International ethical guidelines for health-related research involving humans of the Council for International Organizations of Medical Sciences (CIOMS) make a distinction between reimbursement for reasonable direct costs incurred by research subjects and compensation for the time spent and other inconveniences resulting from study participation (2016, Guideline 13 and Commentary). Having clarified basic terminological and conceptual issues, we can move on and explore the ethical anatomy of payment for research participants. But these offers would likely have no impact on recruitment of individuals who are better-off, i.e., who have better paid jobs or capacity to make more money outside research context, thus potentially biasing the subjects recruitment. https://doi.org/10.1001/jamanetworkopen.2018.7355. American Society of Clinical Oncology Educational Book 39: 1118. Justice for the professional guinea pig. Wertheimer, Alan. 2015; Hamel et al. 2020. Regulations (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Paying for fairness? A. Wertheimer & F. G. Miller - 2008 - Journal of Medical Ethics 34 (5):389-392. 2001. Nipp, Ryan D., Kessely Hong, and Electra D. Paskett. Watson, Judith M., and David J. Torgerson. 2013; Heller et al. Accessed 28 Aug 2021. Importance Offers of payment for research participation are ubiquitous but may lead prospective participants to deceive about eligibility, jeopardizing study integrity and participant protection. It may help to make a positive enrollment decision for those, who feel forced by their low social-economic status (SES) to dedicate time and efforts for searching for a job or earning their living, instead of altruistically contributing to the development of science. 2018). Gelinas, Luke, Emily A. Largent, I. Glenn Cohen, Susan Kornetsky, Barbara E. Bierer, and Holly Fernandez Lynch. Persad, Govind, Holly Fernandez Lynch, and Emily Largent. 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. One of the core values behind the imperative of non-exploitation in research is the value of human autonomy. Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer. 2008. 22) for offering payment to research participants is to boost recruitment and retention rates. JNCI: Journal of the National Cancer Institute 111 (3): 245255. 2013; Gelinas et al. Nuffield Council on Bioethics. https://doi.org/10.1136/bmj.b4142. Journal of Medical Ethics 46 (12): 827828. 2018; Largent and Lynch 2017b). In contrast, the average-wage benchmark for non-exploitive remuneration, mentioned by some authors (Phillips 2011a) would seem fairer as it would make payment offers reasonably attractive to both individuals of SES and to those better-off, thus promoting a fair distribution of research risks and benefits between different social strata. Abstract. 2010. In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set ofmore or less well-justifiedethical recommendations for using payment schemes immune to these problems. In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of. Surprisingly, these questions have been rarely the subject of in-depth discussions in the literature. Pasqualetti, Giuseppe, Giovanni Gori, Corrado Blandizzi, and Mario Del Tacca. May 1, 2021 Paying people to participate in clinical research can be seen as ethically problematic. The American Journal of Bioethics 21 (3): 1131. How payment for research participation can be coercive. First, it is built upon one clearly defined, objective and disjoint divisional criterion, thereby avoiding a mistake of mixing entirely different criteria in one scheme. How IRBs view and make decisions about coercion and undue influence. Increasing value and reducing waste in biomedical research regulation and management. It is claimed that very high or (for other reasons) overly attractive payment may undermine the capacity of individuals to make autonomous decisions regarding study participation, by compromising their voluntariness, ability to adequate understand and assess research risks and benefits, or by forcing them to make choices against their better judgment or deeply held beliefs (Council for International Organizations of Medical Sciences 2016, p. 54). The ethical anatomy of payment for research participants by Dr. Joanna Ryska This is a foundational paper that offers a systematic, principle-based ethical analysis of payment practices and . The 2018 FDA revised guidance regarding participant payment is a step forward in its explicit recognition that reimbursement payments do not raise concerns about undue influence. Most decisions are susceptible to multiple influences, says Grady in the American . Socially valuable human biomedical research is critically dependent on successful enrolment and retention of a sufficient number of appropriate participants, and on their willingness to comply with study procedures and conditions. Read the introductory post here. JAMA 288 (3): 358362. Inclusion of special populations in clinical research: Important considerations and guidelines. It is also inspired by Alex Londons idea of the generic interests conception of the common good by assuming that a social practice or policy is socially valuable when it overall promotes a subset of interests that are sufficiently basic or fundamental to individuals that they are common to each of the members of the community interests in being able to develop their intellectual and affective capacities in order to pursue activities that they find meaningful, and to engage in meaningful relationships with others (2003, p. 21). Paying research subjects for their participation in biomedical studies is an increasingly common practice across different types of research involving healthy volunteers and patients (Grady et al. Secondly, by rejecting the termcompensation, the proposed typology avoids conceptual and normative confusion stemming from ambiguity of this notion in legal terminology, where it stands for both money received in return for services rendered, especially salaries or wages, and for payment of damages for loss or injury (Ryska 2021). 1. 2018. 2018. 2010; Ripley et al. Book Journal of Medical Ethics 46 (12): 835836. Med Health Care and Philos 25, 449464 (2022). Whats the price of a research subject? The reason being the fact that the consequentialistic principle of social beneficence does not exhaust the reining normative framework for human biomedical research. Accessed 28 Aug 2021. 2008. 2015. Authors Luke Gelinas . American Journal of Bioethics 1 (2): 5153. However, only 46.7% were familiar with the ethical guidelines for research with human subjects. BMC Medical Research Methodology 6 (1): 19. 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. CETS 195. The main pragmatic reason (Largent and Lynch 2017a, p. 77 fn. Why healthy subjects volunteer for phase I studies and how they perceive their participation? 2018 Feb 22;378(8):766-771. doi: 10.1056/NEJMsb1710591. In all these cases, payment may enhance recruitment, provided it is designed in a way that targets the underlying barriers, needs, or expectations. European Union. 2019. 31.1(d); art. 2018; Manton et al. Wilkinson, Martin, and Andrew Moore. Health, health care and the problem of intrinsic value. London, Alex J., Jonathan Kimmelman, and Marina E. Emborg. Sully Ben, G., Steven A. Julious, and Jon A. Nicholl. And there is nothing essentially unfair in allowing researchers and altruistically motivated participants to engage in scientifically and socially valuable biomedical research. 2020), risks involved (Menikoff 2001), and even other additional benefits (cf. The authors propose a framework for evaluating the appropriateness of payments to research participants. McNeill, Paul. Recent statistics published by the Center for Information and Study on Clinical Research Participation show that information about potential costs and their reimbursement as well as information about compensation for time off from work are among the most important factors influencing a decision to participate in research forrespectively58% and 40% potential subjects (2019). Clinical Pharmacology & Therapeutics 87 (3): 286293. They distinguish three acceptable . 2006. The ethical anatomy of payment for research participants The ethical anatomy of payment for research participants - [scite report] Picking and choosing among phase I trials. On the contrary, it is considered at least as good as engaging in any other socially valuable and risky service or work. Unger, Joseph M., Riha Vaidya, Dawn L. Hershman, Lori M. Minasian, and Mark E. Fleury. Devine, Eric G., Megan E. Waters, Megan Putnam, Caitlin Surprise, Katie OMalley, Courtney Richambault, Rachel L. Fishmana, Clifford M. Knappa, Elissa H. Pattersona, Ofra Sarid-Segala, Chris Streetera, Laurie Colanaria, and Domenic A. Ciraulo. Cancer patient decision making related to clinical trial participation: An integrative review with implications for patients relational autonomy. Knowledge and attitudes of Chinese medical postgraduates toward Yale Journal of Health Policy, Law, and Ethics 14: 122193. Olivia Grimwade, Julian Savulescu, Alberto Giubilini, Justin Oakley & Anne-Marie Nussberger - 2020 - Journal of Medical Ethics 46 (12):837-839. Menikoff, Jerry. 2019). The ethical anatomy of payment for research participants Med Health Care Philos. 2018. Ndebele, Paul, Joseph Mfutso-Bengo, and Takafira Mduluza. 2020), thereby enhances public trust in research at large. ICH Harmonised Guideline Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2). Healthy volunteers perceptions of the benefits of their participation in phase I clinical trials. Tishler, Carl L., and Suzanne Bartholomae. Thus, the principle of individual beneficence provides additional support for offering money to research subjects. Manton, Kerry J., Cassandra S. Gauld, Katherine M. White, Paul M. Griffin, and Suzanne L. Elliott. The ethical anatomy of payment for research participants. 2008; Pasqualetti et al. In order to bring an end to this terminological (and conceptual) chaos, in this analysis, payment is used as an overarching term that encompasses all forms of financial and in-kind support provided to research participants.Footnote 1 It covers two sub-categories, which will be referred to as recompense and remuneration. Concealment and fabrication by experienced research subjects. Such a mistake affects all typologies of research payments which, alongside recompenses and remunerations, distinguish incentives or inducements payments. The ethical anatomy of payment for research participants 2013. In the United Kingdom, the NHS Health Research Authority guidance (2014) follows terminology developed by the Nuffield Council on Bioethics. 2011. The continuing unethical conduct of underpowered clinical trials. Contemporary Clinical Trials 41: 5561. Altman, Douglas G. 1980. Journal of Medical Ethics 31 (9): 542547. Just compensation: Paying research subjects relative to the risks they bear. 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). 2019. A minimum threshold of physical and mental capacities is necessary (though not sufficient) for an individual to be able to pursue her particular life goals, plans, and projects that express her vision of a good life. 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). https://www.journalslibrary.nihr.ac.uk/hta/hta11480/#/full-report. Scientific research and the public trust. The American Journal of Bioethics 10 (10): 1936. The strength of the obligation weakens whendue to study-specific featurespayment offers are not needed to secure an adequate number of participants, i.e., where it is reasonable to assume that people will be willing to join the study for non-economic and social reasons, e.g., the prospect of direct or ancillary medical benefits, the wish to make a contribution to medical progress or the health of others, scientific curiosity, interest in the goals of the study, the prospect of making friends or having new experiences (Stunkel and Grady 2011; Grady et al. 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Hamel, Lauren M., Louis A. Penner, Terrance L. Albrecht, Elisabeth Heath, Klement C. Gwede, and Susan Eggly. Accessed 28 Aug 2021. Central to the ethical challenges in financially compensating participants in research is that money may unduly induce people to take part. 1986. 2009; Rhodes 2010; London et al. Andif it occurs frequently enoughit may jeopardize the whole research enterprise. 2010. Justice in research requires treating all research participants fairly and equitably, also when it comes to payment for their participation. Most research participants declare they spend the money on everyday living, and only a small part on drugs (Festinger & Dugosh, 2012; Slomka et al., 2007). 2012. A Framework for Ethical Payment to Research Participants. Geller, Stacie E., Abby Koch, Beth Pellettieri, and Molly Carnes. Shamoo, Adil E., and David B. Resnik. - Abstract - Europe PMC Europe PMC is an archive of life sciences journal literature. Bell, Jennifer A.H.., and Lynda G. Balneaves. 2019). 2013. 2013. Often, but not always, the unfair distribution arises because one party to the interaction is in a weak position, due to poverty, ignorance, or extreme urgency, which the other party can take advantage of, offering few benefits (Emanuel 2004, p. 101). Wertheimer, Alan. Nipp, Ryan D., Hang Lee, Emily Gorton, Morgan Lichtenstein, Salome Kuchukhidze, Elyse Park, Bruce A. Chabner, and Beverly Moy. Payment to healthy volunteers in clinical research: The research subjects perspective. 2003. Payment is challenges studies: ethics, attitudes and an new bezahlung Commonwealth of Australia, Canberra. Healthy volunteers and early phases of clinical experimentation. Macklin, Ruth. 2010. 2018). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects. 2017; Fisher et al. The strength of the obligation to offer payment for participation grows in relation to studies which are urgently needed, e.g., to address acute public-health emergencies (such as a dire pandemic), or when there is strong evidence that without payment recruitment, retention and completion of socially valuable studies would be doomed or severely compromised. Accountability in Research 7 (1): 320. 2019. Declaration of Helsinki. 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). Misconceptions about coercion and undue influence: Reflections on the views of IRB members.
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the ethical anatomy of payment for research participants
