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. For more, see Wertheimer, A. and Miller, F., “Payment for Research Participation: A Coercive Offer?” Journal of Medical Ethics 34, no. 5 (2009): 389–392.CrossRefGoogle Scholar

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.Google Scholar

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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); 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.” See the Office for Human Research Protections (OHRP), IRB Guidebook, at Chapter 3, Section B, available at <http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm> (last visited March 22, 2011). (last visited March 22, 2011).' href=https://scholar.google.com/scholar?q=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);+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.”+See+the+Office+for+Human+Research+Protections+(OHRP),+IRB+Guidebook,+at+Chapter+3,+Section+B,+available+at++(last+visited+March+22,+2011).>Google Scholar

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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: (1) additions for risky, burdensome or uncomfortable procedures; (2) pro-rating schedules for partial completion; (3) completion bonuses; and (4) overtime pay for inpatient stays.Google Scholar

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The wage payment model is applicable to: (1) full-time, permanent work; (2) full-time, temporary work; (3) part-time, permanent work; and (4) 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, see Phillips, , supra note 5.Google Scholar

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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; (2) the largest payment tested in either study was $2000, which limits the scope of the findings; and (3) 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. For more on (1) and (2), see Ballantyne, A., “Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement?” Developing World Bioethics 8, no. 3 (2008): 178–191; for more on (3) see Phillips, , supra note 5.CrossRefGoogle Scholar

While the Bentley and Thacker and the Halpern et al. studies showed that common payment amounts did not unduly induce potential subjects, we really do not know much about undue inducement. For example, we do not know whether it is a binary concept or a concept that admits of degrees. It could be that all payments beyond a certain threshold are equally unduly inducing and all payments below the threshold are equally non-unduly inducing; or it could be that payments are more or less inducing depending on the amount. Also, we do not know whether undue inducement, if it exists at all, is objective or subjective. It could be that any given payment is unduly inducing for some people but not others, or unduly inducing for some studies but not others. In any case, it is safe to assume that if undue inducement does indeed exist, then minimizing the amount of a payment will minimize the likelihood that the payment will be unduly inducing. See Bentley, and Thacker, , supra note 58; and Halpern, et al., supra note 56.Google Scholar

This does not require that all studies offer a payment amount sufficient to cover the living expenses of the subject/laborer; only that studies pay at a rate such that full time work would cover the living expenses of the subject/laborer.Google Scholar

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For an argument showing that monetary exploitation can be avoided by offering no money, see id.Google Scholar

For more, see id.Google Scholar

For more on the difference between a required payment and a required payment amount, see id.Google Scholar