Abstract

Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration foreground procedures for minimizing risk for human subjects and require local IRBs to engage in some sort of risk-benefit analysis in decisions to approve or deny proposed research. Existing ethical review and oversight practices are based on the presumption that risk can be clearly identified within the planned activities of the protocol, that metrics can reasonably accurately predict potential hazards, and that mitigation measures can be taken to deal with unintended, harmful, or catastrophic events.