Letter to the Editor: Would You Know an Undue Inducement If You Saw One?
by Abraham P. Schwab
2005. The American Journal of Bioethics 5(5):W17

As Emanuel precisely illustrates, the phrase “undue inducement” can be conceptually dissected to several elements—offering excessive goods, poor judgment, and serious risk of harm. When a trial offers prospective research subjects so much money that their judgment is compromised regarding the serious and unreasonable risks of a trial, we have an undue inducement. On an IRB or ERB, when this effect is predictable, the protocol application should be rejected or deferred. Emanuel’s concern is that the charge of “undue inducement” actually masks other problems. In short, he believes it is a charge that is easily misplaced and poorly understood. I agree.

As an IRB member, however, my experience has not matched Emanuel’s concern that the charge of undue inducement is used to critique protocols that actually have other problems. I am not saying it does not happen, just that I have not had this experience. There are, however, two remarkable things about protocols involving inducements that Emanuel does not address. These are important because they also may lead to misguided objections.

First, the use of inducements in research protocols is inconsistent and arbitrary. We literally have no broadly applicable standards for due inducement in medical research. We could set maximum inducement levels for minimal risk trials, raising the maximum level as risks increase. We could also tie these maximum levels to the number of serious and likely risks associated with an experimental treatment. We could set up a number of reasonable schemas for determining inducements, but we do not do anything. Some protocols simply appear with inducements attached and some do not. The inducement and its level are independent of previous trials with inducements and IRB and ERB members are left to determine on their own whether each separate trial involves an undue inducement. Lacking visible and public standards, this leads to inconsistent and arbitrary judgments about inducements. It may also lead to an undue emphasis on undue inducements because, so far as IRB and ERB can tell, there are not clear reasons one protocol includes inducement and other, similar protocols do not.

Second, the socioeconomic status of research subjects (a point Emmanuel briefly touches on) is precisely what determines the “undueness” of the inducement. I am not concerned that an independently wealthy man with excellent medical coverage will become a research subject because of the compensation that is offered. I am concerned that the mother of a family barely scraping by, with sparse or limited medical coverage will join a trial for the money and the (mostly) free medical care. The difficulty is that both individuals may be part of the same trial. IRB and ERB members are left to judge inducements with their ability to predict the socioeconomic status of future research subjects.

From the abstracted position of the IRB meeting, lacking standards for offering inducements and information about who is being offered the inducement, I am not confident that I would know an undue inducement if I saw one.