'Due' and 'Undue' Inducements: On Pasing Money to Research Subjects

Macklin, Ruth

doi:10.2307/3564136

Cited by 160 publications

(90 citation statements)

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“…An offer to participate in research would be coercive only if the alternative to participation would be a fine or some other punishment. Others are concerned that money could constitute an undue influence or inducement (Macklin 1981). According to this argument, an offer of money could constitute undue influence if it causes someone to act against his or her better judgment and takes risks that he or she otherwise would not take.…”

Section: Undue Influencementioning

confidence: 99%

“…According to this argument, an offer of money could constitute undue influence if it causes someone to act against his or her better judgment and takes risks that he or she otherwise would not take. Money can distort or bias judgment (Macklin 1981). If phase one studies on healthy volunteers did not pay subjects for their participation, then no one would participate.…”

Section: Undue Influencementioning

confidence: 99%

“…According to some, money can be a coercive element, especially for people who are poor (FDA 1998;Macklin 1981). The lure of money, although very powerful, is not the same as coercion, which involves a threat to harm someone's interests (Grady 2001;Wilkinson and Moore 1997).…”

Section: Undue Influencementioning

confidence: 99%

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Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects*

Shamoo

Resnik

2006

The American Journal of Bioethics

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Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors.

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Section: Undue Influencementioning

confidence: 99%

Section: Undue Influencementioning

confidence: 99%

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Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects*

Shamoo

Resnik

2006

The American Journal of Bioethics

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“…However, a number of serious, yet untested, ethical objections have been raised against the practice of using high-magnitude incentives for research participation. Among these objections are that (1) large incentives, particularly if they are provided in the form of cash, could trigger a relapse to drug use (Fry and Dwyer, 2001;Koocher, 1991;Rosenheck, 1997;Shaner et al, 1995); and (2) large incentives may be coercive (Dickert and Grady, 1999;Macklin, 1981;McGee, 1997), meaning they could compromise participants' normal decisional processes and unduly entice them to participate even if they ordinarily would hold preferences against participation. As a result, researchers are often forced to use lower magnitude cash incentives or payments in the form of gift certificates or vouchers that must subsequently be exchanged for goods or services.…”

Section: Introductionmentioning

confidence: 99%

Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion

Festinger

Marlowe

Dugosh

et al. 2008

Drug and Alcohol Dependence

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In a prior study (Festinger et al., 2005) we found that neither the mode (cash vs. gift card) nor magnitude ($10, $40, or $70) of research follow-up payments increased rates of new drug use or perceptions of coercion. However, higher payments and payments in cash were associated with better follow-up attendance, reduced tracking efforts, and improved participant satisfaction with the study. The present study extended those findings to higher payment magnitudes. Participants from an urban outpatient substance abuse treatment program were randomly assigned to receive $70, $100, $130, or $160 in either cash or a gift card for completing a follow-up assessment at 6 months post-admission (n ≅ 50 per cell). Apart from the payment incentives, all participants received a standardized, minimal platform of follow-up efforts. Findings revealed that neither the magnitude nor mode of payment had a significant effect on new drug use or perceived coercion. Consistent with our previous findings, higher payments and cash payments resulted in significantly higher follow-up rates and fewer tracking calls. In addition participants receiving cash vs. gift cards were more likely to use their payments for essential, non-luxury purchases. Follow-up rates for participants receiving cash payments of $100, $130, and $160 approached or exceeded the FDA required minimum of 70% for studies to be considered in evaluations of new medications. This suggests that the use of higher magnitude payments and cash payments may be effective strategies for obtaining more representative follow-up samples without increasing new drug use or perceptions of coercion.

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“…9 It has been well documented in both U.S. and international research that trust in researchers contributes significantly to participation in research, regardless of whether participants understand the study. 10 Finally, concerns have been raised that financial or medical incentives may create undue influence to participate in research, 11 although the degree to which inducements are problematic remains a matter of debate. 12 Given the limited empirical data documenting understanding and voluntariness in international research, we conducted a qualitative pilot study to learn how participants in international clinical trials define research and why they enroll.…”

mentioning

confidence: 99%

Motivations, Understanding, and Voluntariness in International Randomized Trials

Kass¹,

Maman²,

Atkinson³

2005

IRB: Ethics and Human Research

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'Due' and 'Undue' Inducements: On Pasing Money to Research Subjects

Cited by 160 publications

References 0 publications

Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects*

Strategies to Minimize Risks and Exploitation in Phase One Trials on Healthy Subjects*

Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion

Motivations, Understanding, and Voluntariness in International Randomized Trials

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