Incentive Offers in Clinical Studies

In discussing risks and benefits, the institutional review board (IRB) often discusses what makes incentives coercive or non-coercive. However, evaluating whether or not an incentive is coercive is a case by case basis and in some cases the process can be very problematic. Nonetheless, evaluating the ethics and appropriateness of offering incentives to potential subjects as a form of induction to participation in clinical studies is a legitimate concern. There is no doubt, incentives may be viewed or easily translated as unethical medical practices, an offspring of undue influence or coercion of opinion or corruption of judgments (Grant, & Sugarman, 2004). On the other hand, proponents of incentives view the practice as an innocuous motivator (Grant, & Sugarman, 2004).

Perhaps, perceiving incentives as a problematic factor in a clinical research, often considers some factors which induces questionable and suspicious motives that contribute to such perception. Such factors include but are not limited to dependency of human-subjects to the researcher’s need, high risk research, degrading research, vulnerability of potential subjects (children, pregnant women, poverty, poor health condition, socioeconomic status etc), and the equilibrium between the level of the amount offered to subjects for participation to the individual’s moral code or level of aversion to the principle being tested is all relevant to the opponent’s point of view (Grant, & Sugarman, 2004). In addition, opponents believe that looking at other types of acceptable methods for subjects’ recruitment in a clinical trial such as voluntary or wage earning subjects, illuminates the possibility of considering some types of incentive reward as a thread to coercion of opinion, undue influence or corruption of judgments. However, it is not always realistic to run a clinical trial solely based on non-incentive volunteered subjects. Voluntary-type subjects, takes a noble path of true altruism for free gifts, to unknown others (Grant, & Sugarman, 2004). While the wage-earned subjects employ themselves in the business of clinical research in the presence of full knowledge of their entitlements. In addition, wage earned subjects usually understands and conducts full evaluation to the risks and benefits involved, in many cases they actively search for participation. The differences between the two aforementioned recruiting tools to the incentive-type recruitment is that incentive is initiated by the researcher for the sole purpose of enticing or inducing potential or non-potential subject to enroll in a research studies that they may not otherwise be part of; thus it may act as an induction against one’s better judgment.

Regardless of whether the participation for either the wage earned-subjects or incentive induced-subjects is subject for wrong reasons, in science, there is and should be a sense of dignity, pride and integrity in medical practices. For instance, consider the dignity and the pride thereof a soldier in the army who fights for his or her country represents, to the value of a mercenary who technically fights for money (Grant, & Sugarman, 2004). Another example of incentive coercion is the infamous hepatitis experiment conducted in Willowbrook state school. In this study, parents were given incentives to enroll their mentally challenged kids in research and by so doing gave informed assent, which allowed researchers to infect the children with hepatitis (Grant, & Sugarman, 2004, & Nelson, 1998).

The concept of justice in medical research is a generally acceptable assessment intended to be used in protecting vulnerable population or protected class from coercion and risk of research which included but are not limited to risks assessed by incentive or undue influence (Grant, & Sugarman, 2004). For this reason, it is agreeable that it is unacceptable when individuals are unable to evaluate and weigh their risk due to the influences posed incentives. Furthermore, the general rule of thumb for assessment of coerciveness of incentives is based on cases by cases basis evaluation for any clinical trial based on the facts of the voluntary enrollment processes. In other words, when recruiters are encountering difficulties recruiting subjects without large incentive offers, then it is an indicator that there may be conflicting ethical qualms with the subject matter and intended human participant’s principles, morals or simply due to an inherent aversion to the study (Grant, & Sugarman, 2004). More importantly, researchers must evaluate the mental state of their potential human-subjects, and conduct survey on the terms of whether the trial is “worth it” or “regret it” case scenario and should pay attention to the underlining factors that make it difficult in recruiting of human-subjects in a clinical trial.

References

Grant, R., & Sugarman, J. (2004).  Ethics in human research. Do incentives matter? JMP, 29(6), 717-738. Retrieve from http://www.waisman.wisc.edu/events/ethics/sprin06-sem2-incentives-compensation.pdf.

Nelson, R.M. (1998). Children as research subjects. In: J.P. Kahn, A.M. Mastroianni, and J. Sugarman (Eds.), Beyond consent: Seeking justice in research (pp. 47–66). New York: Oxford University Press.