potentially be turned into research fodder without his understanding or ~0nsent.l~~ “[Platients can be harmed when they are prevented from making decisions about their own care, even when, or perhaps especially when, no physical harm occ~rs.””~ Causality An informed consent tort does not just require a breach of duty and an injury. The former must cause the latter. However, as with the duty and injury elements of the tort, causality takes on a distinctive twist in research. As informed consent doctrine embraced the objective “reasonable and prudent patient” standard of disclosure in the early 1970s, courts likewise required an objective approach to causality. An inadequacy of disclosure is said to cause the injury only if the reasonable and prudent person in the patient’s position would have refused the intervention if given adequate information.”’ Courts adoptedthis approach largely out offairness to physicians who would otherwise be vulnerable to patients’ hindsight regrets,”* and out of deference to juries who would otherwise confront difficult hypothetical questions about what this particular person might or might not have done if given different information.”g Unfortunately, this objective causality standard slides over the obvious problem that even for ordinary medical care, people can weigh information very differently in light of their own values and then, ever so reasonably and prudently, come to widely differing decisions.”’ However we might resolve this issue for ordinary care, courts should recognize a more subjective causality standard for research for two reasons. First, it is neither “reasonable” nor “unreasonable” to enter a research study, as aone-size-fits-all judgment. As noted above, research does not aim to benefit any particular person. Since research cannot promise to promote any individual’s self-interest, the across-the-board “reasonableness” judgments make little sense. The decision is as personal as the decision whether to buy a lottery ticket. Second, the only relatively assured outcome of research participation is the altruism of helping others (assuming the project is scientifically adequate).12’ Here especially, the decision is intensely personal, and there can be no single, objectively “reasonable” or intrinsically “prudent” decision. Case law supports this reasoning. In Zalaaar v. Vircimak122 a woman sought cosmetic surgery to remove bags under her eyes. Although she was Mexican and not literate, no one read to her the consent form describing the procedure’s significant risks. An Illinois appellate court found that an objective, “reasonable patient” standard of causality should not be used for aesthetic surgery. Unlike the situation for patients seeking necessary medical treatment, “[tlhe choice plaintiff made was a subjective, personal one that only she could make. We believe no expert or other third party could possibly assert how a reasonable person in the plaintiffs position would have weighed the risks and complications of the surgery...”123 The Wisconsin Supreme Court likewise rejected the objective causality standard where a patient has withdrawn her prior consent. In Schreiber v. Physicians Ins. CO.’~* a pregnant woman amidst delivery repeatedly asked her physician to switch from vaginal delivery to cesarean. “It can lead to absurd results when the known and concrete choice of the actual person may well be ignored if it does not comport to what the hypothetical reasonable person would have chosen .... Applying the objective test to a case such as this would result in the evisceration of Janice’s actually expressed and understood choice oftreatment in favor ofwhat the hypothetical reasonable person would have chosen.”125 Admittedly, a subjective standard of causality could potentially hold physicians hostage to bitter patients’ hindsight. However, safeguards are available. First, juries routinely reckon with factual questions about litigants’ motives and intentions.lz6 Second, investigators can ensure that prospective enrollees have ample opportunity to ask questions. Third, the plaintiff bears the burden of proof in tort litigation. If the plaintiff did not ask questions about any special issues that were important to him, he can not readily cite those issues in asserting that his injury was caused by the defendant’s failure to inform him. As proposed above, the initial presumption should be that the standard consent form is adequate, rebuttable only if the prospective enrollee has explicitly asked for additional information. Conclusion As the energy and financing behind human clinical trials increase, litigation will assuredly increase alongside. Courts will need consid480 THE JOURNAL OF LAW. MEDICINE & ETHICS E. Haavi Morreim erable guidance to understand that, just as clinical research differs from ordinary medical practice, research litigation differs importantly from ordinary medical malpractice litigation. Familiar tort doctrines such as negIigence, battery, and informed consent simply do not fit the realities of research. If they are applied thoughtlessly in this emerging body of cases, research participants may be left without appropriate compensation for very real injuries; reciprocally, investigators may be subjected to unfair standards of liability. Courts need to recognize clinical research as a distinct area of medical activity and to attune tort doctrines specifically to its nuances. Acknowledgments This article is based on