Abstract

For each research protocol that they review, institutional review boards must assess whether the risks of the protocol are acceptable in relation to the potential direct benefits to study participants and/or society. This requirement means that an IRB should first identify risks that are not compensated by direct benefits to the subjects and then judge whether these so-called net risks are acceptable in relation to the benefits to society. We argue that the conventional approach to risk-benefit assessment is not accurate enough to identify all net risks involved in any given protocol. Two relatively new approaches—the component analysis approach and the net risks test—can be of much more use to review boards, especially when used together