How should we regulate risk in biomedical research? An ethical analysis of recent policy proposals and initiatives

Highlights • Risk-adapted approaches to regulating research are ethically appealing. • But ensuring the accuracy and consistency of risk judgments poses a key challenge. • Regulators should stratify risks to participants in 3–4 clearly defined categories. • Risk categories should reflect the risks of “beneficial” and “non-beneficial” research procedures. • Risk-adapted subject protections should be specified for each category to address both the over- and underregulation of research.