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Ethical Flaws in the TeGenero Trial

Emmanuel and Miller (2007) assume that if a review board has approved the study then the risk/benefit ratio for the potential subject must be reasonable, indeed favorable, so we can and should regard compromised consent as valid consent. This assumption, however, is based on a misunderstanding of the task with which review boards are charged. Review boards are not asked to determine whether the risk/benefit ratio to a potential subject is reasonable, instead, they are asked to determine whether the combination of the benefits to society and the subject outweighs the risks to the subject and whether the risks to the subject have been minimized (45 CFR 46.111). Indeed, many trials pass review even though they pose an unreasonable risk/benefit ratio to the individual, and we assume that individuals who enroll in these trials do so not because they seek benefit and find the risk/benefit ratio favorable, but because they desire to engage in an act of altruism. So we cannot assume that simply because a protocol has been approved by a review board that compromised consent should constitute valid consent. Given that any approved trial could present a favorable or unfavorable risk/benefit ratio to the subject, it is especially important that the potential subject understands the nature of the transaction to which the subject is consenting. We need to do our best to ensure that there are no avoidable obstacles to the quality of a potential subject’s consent, which means that we need to consider the type and amount of material benefits offered to the human subjects of research trials. In conclusion, I agree that whether a trial is ethical at its inception should depend on an, “ethical analysis [of the] pertinent substantive issues, . . . and by [itself] the payment . . . [does] not make the trial ethically suspect” (Emanuel and Miller 2007, 76). However, I disagree with Emmanuel and Miller that, “the money paid to the participants is irrelevant to evaluating whether [the] essential ethical criteria were fulfilled” (76). The amount of money offered to subjects and the way in which the offer is presented is relevant to determining whether the quality of the consent is adequate. I have not seen the advertising materials for the TGN1412 trial, and I do not know if the amount of money offered to potential subjects was irresistible, but I do know that Emanuel and Miller have not convinced me that the quality of the consent provided by the subjects was adequate because they did not address either of these issues in their analysis of the trial.