Neither the Declaration of Helsinki nor the CIOMS guidelines requires the provision of post-trial benefits in studies that do not result in the identification of a beneficial intervention, a
Neither the Declaration of Helsinki nor the CIOMS guidelines requires the provision of post-trial benefits in studies that do not result in the identification of a beneficial intervention, aside from the limited obligation under the CIOMS guidelines to share the “knowledge generated” from the research. The excerpt from Emanuel and colleagues implies that failing to provide post-trial benefits in these situations may make research exploitative, at least in some circumstances. Consider, however, the authors’ definition of exploitation: “Party A exploits Party B when B receives an unfair level of benefits as a result of B’s interactions with A. The fairness of the benefits that Party B receives depends upon the burdens that B bears as part of the interaction, and the benefits that A and others receive as a result of B’s participation in the interaction” (emphasis added). In an unsuccessful Phase III study, where the experimental intervention is found to be ineffective and therefore unusable, Party A (the research sponsor) will have lost a great deal of money in research and development expenses that will never be recovered. If the sponsor chooses not to expend additional resources for the benefit of Party B (the research participants), do you agree that this meets the authors’ definition of exploitation? Can a case that the research sponsor has received benefits from the transaction even though the tested intervention has failed? How does this situation compare to the authors’ example of the tow truck driver who jacks up the regular price upon seeing a driver whose car is stranded in a snowbank?
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