The Role of Remuneration in the Decision to Participate in Health Research
DOI:
https://doi.org/10.1344/rbd2020.50.29147Keywords:
Bioethics. Informed consent. Remuneration. Influence. Ethics, Research. Clinical trial.Abstract
The process of informed consent for research participation with human beings aims to provide appropriate information to individuals enabling him or her to make the decision to participate voluntarily, free of external pressures. The possibility of remuneration could interfere in the willingness to consent. The present study aims to evaluate the perception of influence of the monetary payment through research simulations that vary in the level of risk (Bioequivalence and Phase I) and type of monetary payment (with and without). Eighty volunteers participated in the study. The results suggest that remuneration did not interfere with the willingness of the consent process, as participants accepted an invitation to participate in the first research option to which they were invited to and did not feel undue influence.
References
1. Conselho Federal de Medicina. Resolução no. 671/75 de 18 de julho de 1975. Brasília, DF: Conselho Federal de Medicina; 1975.
2. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Helsinki, Finlândia: World Medical Association; 1964.
3. Goldim JR. Bioética e pesquisa no Brasil. In: Kipper DJ, editor. Ética: teoria e prática: uma visão multidisciplinar. Porto Alegre: EDIPUCRS; 2006. p. 17–28.
4. Conselho Nacional de Saúde. Resolução no 01/88 de 13 de junho de 1988. Brasília, DF: Conselho Nacional da Saúde; 1988.
5. Faden RR, Beauchamp TL. A history and theory of informed consent. New York, NY: Oxford University Press; 1986.
6. Goldim JR. Bioética complexa: Uma abordagem abrangente para o processo de tomada de decisão. Rev da AMRIGS. 2009;53(1):58–63.
7. Goldim JR. A participação em projetos de pesquisa em saúde: remuneração, ressarcimento ou gratuidade. Rev Gaúcha Enferm. 2013 Jun;34(2):8–9.
8. English DC. Bioethics: A clinical guide for medical students. New York, NY: W.W. Norton; 1994.
9. Brasil, Ministério da Saúde, Conselho Nacional de Saúde. Resolução no 466, de 11 e 12 de dezembro de 2012. Brasília, DF: Conselho Nacional de Saúde; 2012.
10. Agência Nacional de Vigilância Sanitária. Conceitos técnicos. Brasília, DF: ANVISA; 2018.
11. Agência Nacional de Vigilância Sanitária. Pesquisa clínica. Brasília: ANVISA; 2018.
12. Grady C. Payment of clinical research subjects. J Clin Invest. 2005 Jul 1;115(7):1681–7.
13. Largent EA, Lynch HF. Paying Research participants: the outsized influence of “undue influence”. IRB. 2017;39(4):1–9.
14. McNeill P. Paying people to participate in research: why not? Bioethics. 1997 Oct;11(5):390–6.
15. Wilkinson M, Moore A. Inducement in research. Bioethics. 1997 Oct;11(5):373–89.
16. Human Research Protections Program. Standard operating procedures for the human research protection program. Washington, D.C.: Human Research Protections Program; 2016.
17. Dominguez D, Jawara M, Martino N, Sinaii N, Grady C. Commonly performed procedures in clinical research: a benchmark for payment. Contemp Clin Trials. 2012 Sep;33(5):860–8.
18. Food and Drug Administration. Payment to research subjects information sheet, guidance for institutional review boards and clinical investigators. Washington, D.C.: Food and Drug Administration; 2015.
19. Stunkel L, Grady C. More than the money: a review of the literature examining healthy volunteer motivations. Contemp Clin Trials. 2011 May;32(3):342–52.
20. Chen SC, Sinaii N, Bedarida G, Gregorio MA, Emanuel E, Grady C. Phase 1 healthy volunteer willingness to participate and enrollment preferences. Clin Trials J Soc Clin Trials. 2017 Oct 2;14(5):537–46.
21. Grady C, Bedarida G, Sinaii N, Gregorio MA, Emanuel EJ. Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research. Clin Trials J Soc Clin Trials. 2017 Oct 8;14(5):526–36.
22. Largent EA, Emanuel EJ, Lynch HF. Filthy Lucre or Fitting Offer? Understanding Worries About Payments to Research Participants. Am J Bioeth [Internet]. 2019;19(9):1–4. Available from: https://doi.org/10.1080/15265161.2019.1631076
23. Fernandez Lynch H, Joffe S. Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight. JAMA [Internet]. 2019 Sep 23;322(9):813. Available from: https://jamanetwork.com/journals/jama/fullarticle/2752236
24. Largent EA, Lynch HF. Paying research participants: regulatory uncertainty, conceptual confusion, and a path forward. Yale J Health Policy Law Ethics. 2018;17(1):61–141.
25. Gelinas L, Largent EA, Cohen IG, Kornetsky S, Bierer BE, Lynch HF. A framework for ethical payment to research participants. N Engl J Med. 2018 Feb 22;378(8):766–71.
26. Dickert N, Emanuel E, Grady C. Paying research subjects: an analysis of current policies. Ann Intern Med. 2002 Mar 5;136(5):368–73.
27. Williams B, Entwistle V, Haddow G, Wells M. Promoting research participation: why not advertise altruism? Soc Sci Med. 2008 Apr;66(7):1451–6.
28. Gardner W, Hoge SK, Bennett N, Roth LH, Lidz CW, Monahan J, et al. Two scales for measuring patients’ perceptions for coercion during mental hospital admission. Behav Sci Law. 1993;11(3):307–21.
29. Protas JS, Bittencourt VC, Wollmann L, Moreira CA, Fernandes CF, Fernandes MS, et al. Avaliação da percepção de coerção no processo de consentimento. Rev HCPA. 2007;27(1):172.
30. Taborda JG, Baptista JP, Gomes DA., Nogueira L, Chaves MLF. Perception of coercion in psychiatric and nonpsychiatric (medical and surgical) inpatients. Int J Law Psychiatry. 2004 Mar;27(2):179–92.
31. Mulroney SE, Myers AK. Netter bases da fisiologia. Rio de Janeiro: Elsevier Ltd; 2009.
32. Costa DT, Martins MCF. Estresse em profissionais de enfermagem: impacto do conflito no grupo e do poder do médico. Rev da Esc Enferm da USP. 2011 Oct;45(5):1191–8.
33. Malmqvist E. “Paid to endure”: paid research participation, passivity, and the goods of work. Am J Bioeth. 2019 Aug;19(9);11-20.
34. Millum J, Garnett, M. How payment for research participation can be coercive. Am J Bioeth. 2019 Aug;19(9);21-31.
35. Bernstein M. Payment of research subjects involved in clinical trials is unethical. J Neurooncol. 2003 Jul;63(3):223–4.
Downloads
Published
How to Cite
Issue
Section
License
The author retains the copyright and grants Revista de Bioética y Derecho the right of first publication of the article. All articles published in Revista de Bioética y Derecho are under Creative Commons licensing Recognition – Non Commercial – NoDerivedArtwork (by-nc-nd 4.0), which allows sharing the content with third parties, provided that they acknowledge its authorship, initial publication in this journal and the terms of the license. No commercial use of the original work or generation of derivative works is permitted.