Risk and risk-benefit evaluations in biomedical research

Abstract

One of the fundamental ethical concerns about biomedical research is that it exposes participants to risks for the benefit of others. Therefore, a key ethical requirement for biomedical research studies is that they have an acceptable risk-benefit profile. Yet, despite widespread endorsement of this requirement, how it should be implemented remains controversial. The present paper critically reviews recent debates about risk and risk-benefit evaluations in biomedical research. It traces the history of risk-benefit evaluations in research, which were traditionally conceived of as an extension of the risk-benefit assessment occurring in clinical care. From there, the paper presents and evaluates the four existing ethical frameworks for risk-benefit evaluations: the component analysis, the integrative approach, the agreement principle, and the net risks test. It is argued that the net risks test is superior to the alternative approaches, but fails to offer guidance for evaluating the ethical acceptability of risks that participants incur for research purposes only. This leaves two of the fundamental problems of risk-benefit evaluations in research inadequately addressed, namely, (1) how to weigh the risks to the individual research participant against the potential social value of the knowledge to be gained from a study and (2) how to set upper limits of acceptable research risk. Discussions about the '‘minimal’’ risk threshold in research with participants who cannot consent, such as children or patients with dementia, go some way to specifying upper risk limits in this study context. However, these discussions apply only to a small portion of research studies. The paper ends by highlighting several important questions that future research will need to address.