Litigation in clinical research: Malpractice doctrines versus research realities

As human clinical research trials have proliferated, so has litigation. Mainly deeming research injuries as just a species of medical malpractice, confused courts have largely failed to recognize crucial differences between clinical trials and medical practice. However, the tort doctrines commonly applied to medical malpractice, such as negligence, battery, and informed consent, do not fit research well. Employed uncritically, these doctrines can leave research subjects without appropriate remedy for their injuries, and reciprocally may subject investigators, sponsors, and others conducting research to unfair standards of liability. This article argues that human clinical trials need tort doctrines specifically adapted to the research setting.