Abstract

A core tenet of research ethics is that risks assumed by research participants are reasonable, balanced, and minimized in relation to benefit to the individual and to society. It is also generally accepted that people who cannot give their own informed consent ought only to be exposed to low risks in research, unless there is a compensating potential for direct benefit.However, there is no consensus on whether individuals should be able to voluntarily consent to high net risk in research—or, in other words, to research that is not justified by direct benefits to the individual and must be justified by benefits to others in society. The Belmont Report—perhaps the most canonical document in research ethics—does not...