specifically adapted to the research setting. Case Overview Case law regarding clinical research is relativelylimited.‘2 Some ofthe most well-known cases arose from research conducted under United States government auspices. Some research was conducted directly on military troops, for instance to evaluate the effects of LSD13 or the radiation from nuclear bomb testsL4 In other cases military and other government agencies collaborated with civilian medical institutions. Many projects sought information about the hazards and potential medicalvalue of radiation on the human body.15 From 1960-1972, for instance, the Department of Defense sponsored research to understand the potential effects of radiation on soldiers in the battlefield. The mainly black, indigent cancer patients, falsely told they were being treated for their cancer, were subjected to total body radiation.’6 E. Haavi Morreim, Ph.D., is professor of bioethics in the College of Medicine, University of Tennessee Health Science Center. Her writings have focused on the legal and ethical implications of medicim’s changing economics, and on the ethics and law of human clinical research trials. - ~~ 474 THE JOURNAL OF LAW, MEDICINE & ETHICS E. Haavi Morreim with plutonium to evaluate its long- and short-term effects.17 certainty or greater risks.30 Some cases featured straightforwardly medical, as opposed to mil- In ordinary medical care, uncertainties and risks can permeate approach will help that patient, or sometimes the physician simply thinks he can improve on existing options. In any event, the bare fact that an innovation elevates the uncertainties does not, of itself, render that innorightly argue that innovations like new surgical procedures or off-label drug uses ought vation aform ofresearchm - even ifone might to be validated by research before they become widely used. Goals, not uncertainties, mark the fundamental difference between research on the one hand, versus ordinary practice or clinical innovation on the other. Ordinary and innovative practices both aim to benefit a single individual patient, responding to that indi- ~ If courts are to take a jurispmdentidb jected into debilitated elderly patients at a chronic disease hospital, likewise without their knowledge or c~nsent.’~ In these cases the litigation arose many years after the actual events, hence focused heavily on procedural issues such as whether fraudulent concealment should toll the statute of limitations.20 Because so many of these experiments were carried out under government auspices, a second common issue was whether qualified immunity would protect government workers from liability.21 Research by private institutions and scientists has also spawned litigation. Mink v. University of Chicago,22 for instance, concerned women who were secretly given diapproach to research-related injuries and injustices, they need a dear Concept Of what research is and how it differs, on one hand, from ordinary medical treatment and, on the other, from clinical innovation. ethylstilbestrol (DES) during the early 1950s as an experiment to try to prevent miscarriage. Karp v. C001ey~~ examined the adequacy of informed consent in a 1969 artificial heart implantation. Burton ZI. Brooklyn Doctors Hospitap4 involved a 1950s evaluation of high-level oxygen in the care of premature infants who were enrolled without their parents’ knowledge or consent, resulting in the plaintiffs blindness.25 In Moore v. Regents ofthe University ofCalifrnia,26 the physician who removed a patient’s spleen to treat leukemia discerned that the patient’s cells could be developed into alucrative cell line. ThereaRer the patient was told to return repeatedly - under the ruse that it was for his benefit - so that the physician could continue to gather various tissue samples for research and commercial purposes. Moore is somewhat atypical of contemporary cases, in that it featured completely unconsented research. More commonly the new brand of suits alleges inadequate information. In Grimes 8. Kennedy K~ieger,~~ public health researchers attempted to determine whether less intensive procedures for removing lead from older housing in low-income neighborhoods might be sufficiently safe for children, while also inexpensive enough to encourage landlords to clean up rather than tear down such buildings. The study tested three lead abatement techniques and followed the children who lived in those homes. Allegedly the investigators permitted children to stay in a lead-borne environment even while lead levels in their blood rose, without informing the children’s parents promptly A flurry of cases followed the 1999 death of Jesse Gelsinger during a gene transfer study. Most of these cases claimed informed consent was inadequate, alleging injuries such wrongful death, fraud, negligence, emotional distress and the like. Additionally a number of these suits attempted to institute novel tort causes, such as breach of the Nuremberg-based right to be treated with dignity, and violation of the federal rules that govern human research protection^.^^ A Need for Clarity: Research Versus Medical Practice If courts are to take a jurisprudentially well-founded approach to research-related injuries and injustices, they need a clear concept of what research is and how it differs, on one hand, from ordinary medical treatment and, on the