Under the United States human subjects regulations, it is currently permissible to compensate participants for their involvement with research studies, including clinical trials. According to the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA), this payment cannot be considered a benefit and must not cause undue influence in a person’s decision to join or stay in a clinical trial. This means that a payment should not be in an amount that would make someone willing to take on more risk than they are comfortable with in order to gain payment. Despite this allowance, there is some controversy over whether subjects should be paid and how much. This article takes a look at the recent research literature on whether or not to pay research participants.
An argument for participant payments
In his article on the investigator-subject relationship, Benjamin Sachs of the New York University Center for Bioethics describes six ethical rules that are observed in the research realm, but not in other relationships, which may result in a power differential or coercion. One of these ethical considerations is to not pay subjects “too much,” defined as Risk Payment (Sachs, 2010). Sachs postulates that payment for participating in research is unjustly suppressed, especially when in other fields (such as occupations with significant hazards to the employee), increased payment is encouraged for a person to take on the possible risks. This is closely related to the ethical concept of undue inducement, where it is unethical for an investigator to offer a “large material reward” to someone for participating in research. However, Sachs argues this is the same as giving a bonus in the employer-employee relationship, a welcomed and encouraged process across many industries.
An argument against participant payments
In the article “Payment of research subjects for more than minimal risk trials is unethical” (Wong, 2011), the authors provide an argument contrary to Sachs’. In their article, they state that paying subjects for participating in greater than minimal risk studies (including clinical trials) is unethical. This is primarily based on the concept of undue influence, stating that, as there is an uncertain probability of a person experiencing at least one risk due to the research, payment is the only guarantee of participating. Supplementary to this position, a person cannot always be fully informed of risk, or there could be too many risks for the person to fully grasp. The authors also state that it is morally wrong to ask a person to trade their health for payment, as if it was a commodity. Finally, they utilize a logical argument that assumed 1) people are less willing to participate in research as risk increases; and 2) people with greater financial needs are more likely to participate in research. Thus, an unjust situation is present when financially compensating subjects, as people who are economically challenged are more likely to be subject to undue influence and participate in research.
Where do you stand?
Does your organization pay stipends to research participants? What ethical concerns do you have about participant payments? Join the discussion in the comments.
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Sachs B. The exceptional ethics of the investigator-subject relationship. Journal of Medicine and Philosophy. 2010; 35:64-80.
Wong JC, Bernstein M. Payment of research subjects for more than minimal risk trials is unethical. The American Journal of the Medical Sciences. 2011; 342(4): 294-296.