Are Risks and Benefits of Oncological Research Protocols Both Incommensurable and Incompensable?
van Luijn, H.E.M.
Accountability in Research 2007 July-September; 14(3): 179-196
Institutional review boards (IRBs) are legally required to determine whether the balance between the risks and benefits (the risk-benefit ratio or RBR) of a proposed study is "reasonable" or "proportional". This obligation flows from their duty to protect the interests of research subjects. It has been argued that it is difficult, perhaps even impossible for IRBs to determine the RBR of studies, because the risks and benefits are not only heterogeneous, but also incommensurable. After arguing that the relevant meaning of incommensurability is incomparability, we discuss whether the risks of participating in a trial and the benefits are comparable. We conclude that at least the risks and the benefits to participants are comparable. In the last section we show that the main problem of RBR analyses is that of interpersonal incompensability. IRBs have to assume that risks to research subjects be compensated by benefits to others. The question is: To what extent? When does it become unreasonable to ask that patients accept the risks of participating in a trial for the benefit of science and/or future patients?
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Evaluating the Risks and Benefits of Phase II and III Clinical Cancer Trials: A Look at Institutional Review Board Members in the Netherlands van Luijn, H.E.M.; Musschenga, A.W.; Keus, R.B.; Aaronson, N.K. (2007-01)
The Evaluation of the Risks and Benefits of Phase II Cancer Clinical Trials by Institutional Review Boards (IRB) Members: A Case Study van Luijn, H.E.M.; Aaronson, N.K.; Keus, R.B.; Musschenga, A.W. (2006-03)There are indications that institutional review board (IRB) members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members ...