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Historically, litigation played a small role in protecting human subjects of biomedical research in the U.S. Although the trial of Nazi physicians at Nuremburg for experiments on concentration camp inmates played a key role in creating modern research ethics, most scrutiny of researchers since has been conducted by regulators and IRBs applying human subjects regulations rather than by judges and juries assessing liability. Some court cases, including Gelsinger and Grimes, have begun to change this. This lecture, by an attorney initiating a number of important cases, explored the new role for litigation, addressed critics, and suggested how litigation and regulation should combine to protect human subjects.