The project will employ both normative and empirical approaches. Empirical studies include online surveys of the lay public to ascertain their views on informed consent and assess their perception of risk. Normative studies apply norms of research ethics to analyze various comparative effectiveness trials and proposed informed consent practices or research analyses. In the past fiscal year, 2 normative analytic papers and 1 empirical paper was published in NEJM, JAMA, and Annals of Internal Medicine.