A living wage for research subjects

Journal of Law, Medicine and Ethics

Volumn 39, Issue 2, 2011, Pages 243-253

  Phillips, Trisha B ^a  

^a MISSISSIPPI STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOETHICS; ECONOMICS; HUMAN; MOTIVATION; PSYCHOLOGICAL ASPECT; RESEARCH ETHICS; RESEARCH SUBJECT; SALARY AND FRINGE BENEFIT;

BIOETHICAL ISSUES; ETHICS, RESEARCH; HUMANS; MOTIVATION; RESEARCH SUBJECTS; SALARIES AND FRINGE BENEFITS;

EID: 79955847162     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2011.00593.x     Document Type: Article

References (77)

1. Critics used to worry that offers of money would compromise the voluntariness of consent, but this concern about coercion has recently been put to rest.
2. A. Wertheimer and F. Miller, "Payment for Research Participation: A Coercive Offer?" Journal of Medical Ethics 34, no. 5 (2009): 389-392.
3. This paper discusses the issue as it pertains to adult subjects participating in domestic trials. Payments to children or their guardians, and payments to subjects in internationally sponsored trials raise separate and additional concerns that will not be addressed in this paper.
4. For example, see R. Macklin, "Due and Undue Inducements: On Paying Money to Research Subjects, " IRB 3, no. 1 (1981): 1-6;
5. P. McNeil, "Paying People to Participate in Research: Why Not?"Bioethics; 11, no. 5 (1997): 390-396.
6. For example, see N. Dickert and C. Grady, "What's the Price of a Research Subject? Approaches to Payment for Research Participation, " New England Journal of Medicine 341, no. 3 (1999): 198-203.
7. T. Phillips, "Exploitation in Payments to Research Subjects, " Bioethics 25, no. 4 (2011).
8. R. Ashcroft, "Money, Consent, and Exploitation in Research, "American Journal of Bioethics 1, no. 2 (2001): 62-63.
9. C. Grady, "Recruitment of Research Subjects, " SoCRA Source 27 (2001): 33-37
10. J. Aby, A. Pheley, and P. Steinberg, "Motivation for Participation in Clinical Trials of Drugs for the Treatment of Asthma, Seasonal Allergic Rhinitis, and Perennial Nonallergic Rhinitis, "Annals of Allergy, Asthma and Immunology 76, no. 4 (1996): 348-354.
11. According to a recent study, 58% of all participants in a phase 1 trial cited money as their primary reason for participating. Forty-three percent of the participants were unemployed at the time of the trial.
12. For more, see L. Stunkel, M. Benson, L. McLellan, N. Sinaii, G. Bedarida, E. Emanuel, and C. Grady, "Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form, " IRB: Ethics & Human Research 32, no. 4 (2010): 1-9.
13. According to Federal Regulations, "Informed consent must be sought from each prospective subject or the subject's legally authorized representative." Title 45, U.S. Code of Federal Regulations (CFR), Part 46. Protection of Human Subjects: 45 C.F.R. § 46.111(a)(4).
14. According to the handbook for interpreting the regulations published by the Department of Health and Human Services (DHHS), "Investigators may seek consent only under circumstances that minimize the possibility of coercion or undue influence."
15. According to the handbook, "IRBs should review both the amount of payment and the proposed method of disbursement to assure that neither entails problems of coercion or undue influence. Such problems might occur, for example, ... if the payment were unusually large.
16. M. B. Kimberly, K. S. Hoehn, C. Feudtner, R. M. Nelson, and M. Schreiner, "Variation in Standards of Research Compensation and Child Assent Practices: A Comparison of 69 Institutional Review Board-Approved Informed Permission and Assent Forms for 3 Multicenter Pediatric Clinical Trials, " Pediatrics 117, no. 5 (2006): 1706-1711.
17. J. Latterman and J. F. Merz, "How Much Are Subjects Paid to Participate in Research?" American Journal of Bioethics 1, no. 2 (2001): 45-46.
18. N. Dickert, E. Emanuel, and C. Grady, "Paying Research Subjects: An Analysis of Current Policies, " Annals of Internal Medicine 136, no. 5 (2002): 368-373.
19. Dickert, Emanuel, and Grady contacted 53 research organizations and 32 responded (9 of 12 academic research centers.
20. 7 of 20 large U.S. pharmaceutical companies;
21. 8 of 12 contract research organizations; and 8 of 9 independent IRBs)
22. C. L. Fry, A. Ritter, S. Baldwin, K. J. Bowen, P. Gardiner, T. Holt, R. Jenkinson, and J. Johnston, "Paying Research Participants: A Study of Current Practices in Australia, " Journal of Medical Ethics 31, no. 9 (2005): 542-547.
23. Another issue is determining whether and to what extent additional factors should be calculated into payments. For example, questions arise on varying payments based on whether the subject is a healthy volunteer or a patient, and whether the payment amounts should include.
24. additions for risky, burdensome or uncomfortable procedures.
25. pro-rating schedules for partial completion.
26. completion bonuses.
27. overtime pay for inpatient stays.
28. J. Andersen and C. Weijer, "The Research Subject as Wage Earner, " Theoretical Medicine 23, nos. 4-5 (2002): 359-376;
29. C. Grady, "Payment of Clinical Research Subjects, "Journal of Clinical Investigations 115, no. 7 (2005): 1681-1687.
30. L. Dunn and N. Gordon, "Improving Informed Consent and Enhancing Recruitment for Research by Understanding Economic Behavior, "JAMA 293, no. 5 (2005): 609-612.
31. C. Saunders and A. Sugar, "Letter to the Editor, "New England Journal of Medicine 341, no. 20 (1999): 1550-1551
32. P. Thompson, "Letter to the Editor, "New England Journal of Medicine 341, no. 20 (1999): 1551.
33. This list does not include reimbursement for actual expenses because this is not payment for participation.
34. The wage payment model is applicable to.
35. full-time, permanent work.
36. full-time, temporary work.
37. part-time, permanent work.
38. part-time, temporary work. Participation in some studies, for example, an outpatient clinical trial, will be analogous to part-time, temporary work because it will include brief periods of active participation and longer periods of inactive participation. Participation in other studies, for example, multi-day inpatient studies, will be analogous to full-time, temporary work because subjects will have prolonged periods of active participation. For a second argument for the wage payment model.
39. For the purpose of payment, Dickert and Grady propose to treat all research subjects as unskilled workers because the contribution of each subject is similar to unskilled labor. The value of this contribution holds constant, even though any given research subject might otherwise be skilled (or unskilled) or employed (or unemployed).
40. According to the ISI Web of Knowledge, Dickert and Grady's article has been cited in at least 105 other articles since 2000.
41. U.S. Bureau of Labor Statistics, Economic News Releases, Table B-8: Average Hourly and Weekly Earnings of Production and Non-supervisory Employees on Private Nonfarm Payrolls by Industry Sector, Seasonally Adjusted, available at (last visited March 8, 2011).
42. In 1999, when Dickert and Grady first proposed their base wage, the nonfarm production wage was $10.00/hr and the minimum wage was $5.15/hr. In 1999, the nonfarm production wage was nearly double the minimum wage.
43. in 2010 it was more than double. United States Department of Labor, "Wage and Hour Division, " Minimum Wage available at (last visited March 8, 2011).
44. Dickert and Grady initially calculated a total payment of $390 based on a 29-hour commitment, the nonfarm production wage of $10/hr in 1998, and $100 supplement for the inconvenience of taking the drug and the discomfort of serial blood draws. Because this paper focuses only on the base wage (and not augmentations for risky, burdensome or uncomfortable procedures) the updated and comparison payments are simply the product of the base wage and the 29-hour commitment.
45. United States Department of Labor, Fair Labor Standards Act of 1938: Maximum Struggle for a Minimum Wage, available at (last visited March 8, 2011).
46. United States Department of Labor, Fair Labor Standards Act Advisor: Exemptions, available at (last visited March 8, 2011).
47. A number of organizations and researchers have recently made this claim. For example, Robert Pollin argues that although the minimum wage was originally intended to be a living wage, these intentions are no longer realized because the minimum wage has failed to keep pace with inflation. "The real value of the national minimum wage as of 2001, at $5.15/hr, was 37% below its peak value in 1968 of $8.14 (in constant 2001 dollars), even while average labor productivity rose in the United States by roughly 80% between 1968 and 2001. This means that if the real value of the national minimum wage had risen exactly in step with the rate of productivity growth, the minimum wage as of 2001 would be $14.65. More to the point, someone who works full-time for 52 weeks at the $5.15 national hourly minimum would earn $10, 712 for a year. This figure is 12.2% below the 2001 national poverty threshold for a family of two (one adult, one child), and a broad range of research consider such official poverty thresholds to be between 25% and 50% too low." R. Pollin, "Evaluating Living Wage Laws in the United States: Good Intentions and Economic Reality in Conflict?" Economic Development Quarterly 19, no. 1 (2005): 3-4.
48. R. V. Burkhauser and J. J. Sabia, "The Effectiveness of Minimum-Wage Increases in Reducing Poverty: Past, Present, and Future, " Contemporary Economic Policy 25, no. 2 (2007): 262-281.
49. E. Roston, "How Much Is a Living Wage?" Time 159, no. 14 (2002): 52-54.
50. For example, see A. Ballantyne, "HIV International Clinical Research: Exploitation and Risk, " Bioethics 19 (2005): 476-491.
51. F. Miller and H. Brody, quot;What Makes Placebo-Controlled Trials Unethical?"American Journal of Bioethics 2 (2002): 3-9; and D. Resnik, quot;Exploitation in Biomedical Research,"Theoretical Medicine 24, no. 3 (2003): 233-259.
52. A. Wertheimer, Exploitation ( Princeton: Princeton University Press, 1996).
53. Participants of the 2001 Conference on Ethical Aspects of Research in Developing Countries, "Moral Standards for Research in Developing Countries: From 'Reasonable Availability' to 'Fair Benefits, '" Hastings Center Report 34, no. 3 (2004): 17-27.
54. D. Grant and M. N. Trautner, "Employer Opinions on Living Wage Initiatives, " WorkingUSA: The Journal of Labor and Society 8, no. 1 (2004): 71-82.
55. A. Bernstein, "Sweatshop Reform: How to Solve the Standoff, " Business Week 3627 (May 3, 1999): 186-190.
56. D. G. Arnold and N. E. Bowie, "Sweatshops and Respect for Persons, "Business Ethics Quarterly 13, no. 2 (2003): 221-242.
57. s.v. "living wage, "available at (last visited March 8, 2011).
58. A. K. Glasmeier, Poverty in America: Living Wage Calculator, available at (last visited March 8, 2011).
59. Universal Living Wage, available at (last visited March 8, 2011).
60. The 2009 HHS Poverty Guidelines, available at (last visited March 8, 2011).
61. Exceptions include the Harvard University Living Wage Campaign, available at (last visited March 8, 2011).
62. J. Wilson and D. Hunter, "Research Exceptionalism, " American Journal of Bioethics 10, no. 8 (2010): 45-54.
63. The 2009 poverty level for a family of four was $22, 050: $22, 050/year × 110%÷ 2, 000 hours/year =$12.13/hour.
64. S. Halpern, J. H. T. Karlawish, and D. Casarett et al., "Empirical Assessment of Whether Moderate Payments Are Undue Inducements for Participation in Clinical Trials, " Archives of Internal Medicine 164, no. 7 (2004): 801-802.
65. J. P. Bentley and P. G. Thacker, "The Influence of Risk and Monetary Payment on the Research Participation Decision Making Process, " Journal of Medical Ethics 30, no. 3 (2004): 293-298.
66. The studies have been challenged on at least three bases: (1) Bentley and Thacker's subjects were pharmacy student who had greater than average experience with clinical trials, which may have biased the sample in this study
67. the largest payment tested in either study was $2000, which limits the scope of the findings
68. the studies recorded only hypothetical willingness to participate, which is different in important respects from actual willingness to participate, which challenges the ability of the study to answer the question of whether large payments are actually unduly inducive.
69. A. Ballantyne, "Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement?" Developing World Bioethics 8, no. 3 (2008): 178-191
70. This does not require that all studies offer a payment amount sufficient to cover the living expenses of the subject/laborer;
71. only that studies pay at a rate such that full time work would cover the living expenses of the subject/laborer.
72. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979), available at (last visited March 8, 2011);
73. U.S. Code of Federal Regulations (CFR), 45 C.F.R. § 46 and 21 C.F.R. § 56. Exceptions include privately funded research that will not be used to support an application for FDA approval and other exemption listed in 45 C.F.R. § 46.101b.
74. According to Nancy King, "Payment to subjects, though technically a collateral benefit, is classified and treated separately [from the standard risk/benefit assessment] in research ethics and policy." For more, see N. King, "Defining and Describing Benefit Appropriately in Clinical Trials, " Journal of Law, Medicine & Ethics 28, no. 4 (2000): 332-343.
75. For a more thorough presentation of this argument,
76. For an argument showing that monetary exploitation can be avoided by offering no money, see id.
77. For more on the difference between a required payment and a required payment amount, see id.