Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities

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1 INDEPENDENT Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities E. Haavi Morreim H uman clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period? To date, some twenty million Americans have participated in clinical research trials3 that now are as common in the private practice setting as in a~ademia.~ For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research5 to formulate recommendations to protect human research subjects. The Commission s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research. In 1981 the Common Rule unified the human subject protection system across the spectrum of federal agencies and departments. Under those rules, institutions and researchers were largely free to proceed with a minimum of interference.6 In the past few years, however, that placid picture has changed. The federal government s Office of Human Research Protections (OHRP) has disciplined numerous institutions for rules violations. The Justice Department, via the False Claims Act, pursues research that misuses federal funds? Perhaps the greatest upheaval has come from tort litigati~n.~ Medical researchers experienced relatively few lawsuits until, in the 199Os, two events triggered a flurry of claims. The first was a 1995 report by President Clinton s Advisory Committee on Human Radiation Experiments, documentingwidespread abuses in the 1940s and beyond, as government agencies and others conducted radiation research on a host of unwitting citizens. A number of suits followed. The second event was the 1999 death of Jesse Gelsinger, an 18 year old who participated in gene transfer studies at the University of Pennsylvania. Allegedly the study s risks were too great and the disclosures too limited. The ensuing litigation triggered a number of similar suits alleging inadequate informed consent, conflict of interest, and theliie. After reviewing general trends in this emerginglitigation, I will discuss fundamental differences between research and ordinary medical practice. Whereas ordinary medicine and even innovative treatment aspire to benefit the individual patient, research seeks generalizable knowledge, typically via protocols that do not aim to benefit any par- ticular research subject. Research thus subordinates clinical medicine s focus on the individual to its own, broader goals. Because many courts regard research-related injuries as simply a genre of medical malpractice, corresponding case law does not yet reflect the distinctive issues of research. After exploring courts confusion, this Article will review four of the most prominent causes of action for addressing injuries that arise through human clinical research. I will show first, that, negligence concepts applied to medical malpractice must be reformulated for research. Second, breach of fiduciary duty is essentially inapplicable in research, because investigators are not fiduciaries of research subjects. Third, battery emerges as a special kind of tort in research. Finally, although breach of informed consent is an important cause of action in research cases, malpractice-based informed consent doctrines must be substantially modified before they can be suitably applied to human clinical trials. In the end, if familiar medical malpractice doctrines are applied uncritically to research injuries, injured research participants may sometimes be left without appropriate remedy. At the same time, investigators, sponsors, and others conducting research may be subjected to inappropriate or unfair standards of liability. Clear jurisprudential thinking requires that tort doctrines be 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 , 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

2 ~ E. Haavi Morreim with plutonium to evaluate its long- and short-term effects.17 Some cases featured straightforwardly medical, as opposed to mil- certainty or greater risks.30 In ordinary medical care, uncertainties and risks can permeate 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 diethylstilbestrol (DES) during the early 1950s as an experiment to try to prevent miscar- riage. 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 other, from clinical innovation. Con- If courts are to take a jurispmdentidb approach 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. 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 innovation aform ofresearchm - even ifone might rightly argue that innovations like new surgical procedures or off-label drug uses ought 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- vidual s specific needs Ad interests. Indeed, innovation is often the ultimate individualization of cape, a customized therapy. The goal of research is fundamentally different. It does not aim to benefit any specific individ~al?~ but rather to advance generalizable knowledge and thereby to benefit broader pop~lations.3~ Clinical medical science requires that data be gathered systematically, typically according to a protocol that provides appropriate hypotheses, controls, definitions, procedures and endpoints. Otherwise the facts being gathered cannot yield scientifically credible generalizations - and the project is unworthy of the name clinical research. This is not simplistically reducible to intent. The bare fact that a physician would like to draw general conclusions from his personal observations does not mean that he has undertaken research. The CNcial factor is the design and discipline ofthe activity: activity to test an hypothesis, draw conclusions, and thereby develop generalizable By implication, instead of attuning interventions to each patient, the methodologies of research, such as randomization, double-blinding and placebo control, must often subordinate an enrollee s personal interests and desires to the protocol. The patient may be exposed to the unknown hazards of a new treatment or may receive only placebo instead of an active drug. Commonly a drug dosage can not be raised or lowered even when such a change might suit the patient better, unless explicitly permitted by the protocoi. The patient may be required to forego helpful medications altogether during a washout period, or may be precluded from treating side-effects with adjuvants like decongestants. He may have to remain in the hospital longer than he would otherwise need to, or may experience unexpected ~ide-ef ects.~7 Admittedly, many research projects have in fact brought significant benefits to participants as well as future patients. People in research may fare better simply from the extra attention of being in a tfialf8 or they may receive at no cost some medications they could not otherwise afford. However, it is not the goal of any research protocol to benefit any specified individual. That happens by good fortune, not by design. Moreover, there is no advance assurance that anyone will benefit. [O]f all drugs tested in the hope of approval by the Food and Drug Administration, about 80 percent fails39 Even in Phase IV research, which compares approved regimens, the subject may be assigned to NATIONAL HEALTH REFORM AND AMERICA S UNINSURED * FALL

3 INDEPENDENT a drug that is personally less effective for The bare fact that a physician him than the alternative^."^ In research, subjects' individual needs like to draw genera' and preferences &I only enter in either of conclusions from his personal two ways: via whatever flexibility a protocol observations does not mean that may have built in to accommodate personal variation and preference, or via removing he has undertaken research. that person from the study altogether. In The crucial factor is the design this sense, the interests of the individual constitute constraint;"ll that is, def- and discipline of the activity: erence to individuals is a limiting factor, activity to test an hypothesis, not the goal of the activity?2 draw conclusions, and thereby This does not mean, of course, that a redevelop generalizable knowledge. search project can not provide red benefits for enrollees, or that an investigator cannot rightly say to a prospective enrollee that a given study might help him. Indeed, a trial may offer hope for those who have none. The important point is that even a plausibly predicted benefit is never aimed specifically at this or that individual. Confusion in the Courts Early courts regarded any sort of experimentation or innovation as malpractice because, by definition, these activities are a deviation from standard practice.43 Not until 1935 do we see any recognition that deviating from routines can be legitimate.44 Only much later do we see courts more explicitly addressing research. However, even while courts now understand that research-based deviation from medical practice is not per se malpractice, they nevertheless have often regarded research-based injuries as just another genre of medical malpractice. Moore v. Regents45 exemplifies. Although John Moore's leukemia genuinely required the removal of his spleen, thereafter Dr. David Golde repeatedly required Moore to return to Los Angeles from his home in Seattle so that Golde could remove blood, blood serum, skin, bone marrow aspirate, and sperm samples under the pretext that these procedures were for the patient's benefit and could only be performed at UCJA under Golde's dire~tion.~~ In fact, virtually none of these post-splenectomy samplings were therapeutic?' Moore's active treatment ended with the splenectomy? Nevertheless, the California Supreme Court treated the case as ordinary medical malpractice, regarding Golde's repeated duplicitous invasions as though they were 'treatment" and the research as simply a standard medical conflict of interest, analogous to a physician's ownership of a pharmacy to which he might refer his patients. Although the court agreed there had been breach of informed consent and of fiduciary duty, its analysis was deeply problematic. First, the medically pointless tissue removals could not have been malpractice because they were not medical practice at all?9 Second, applying standard malpractice tort concepts to this situation underrates the wrong Golde did. Medical malpractice requires not just that the physician breach a duty of care, but that this breach cause an injury - typically a physical injury. However, though Moore was caused inconvenience, personal expense,5o and the discomfort of needless punctures, these were hardly the most important injury. Moore was exploited, completely without his knowledge or consent, for ulterior purposes. Yet this dignitary offense is not typically deemed a compensable injury under malpractice law. And while the court did find that Dr. Golde breached his physician-patient fiduciary duty, breaches of fiduciary duty do not ordinarily give rise to significant non-economic damage awards. The court denied Moore's property claim to the financial proceeds of the cell line, leaving him with only a limited settlement. Hence, standard medical malpractice theories appear too limited to address the significance of the abuse. A similar problem appears in Kentke v. The Menninger Clinic In~.~l A schizophrenia patient, voluntarily admitted to a psychiatric hospi- tal, was told by his physician that he would benefit from participating in a research study. As the study proceeded the patient, increasingly depressed and psychotic, wandered away from the institution and died from exposure. The court dismissed all of claims other than medical malpractice on the ground that these were simply duplicative of the malpractice claim. "Kansas courts will not permit a plaintiff to 'creatively classify' a claim as something other than one for medical malpractice if the substance of the - claim concerns the _. physician-patient relati~nship."~~ This reasoning is misguided. Admittedly, some of Kernke's care was routine and would rightly be addressed under familiar malpractice doctrines. But the bare fact that a physician has performed an intervention requiring professional knowledge or skill does not mean that intervention was medical prac- ti~e.5~ Much of Kernke's care was not ordinary, including the washout period and the experimental medicati0n.5~ In contrast to the foregoing cases, a few courts grasp a major distinction between research and ordinary medical care. In one such case the plaintiffs, suffering from lymphoma, had been enrolled in a trial that was discontinued. When they demanded to be entered into a new research study, the court denied they had any valid claim. Research is not treatment. Experiments require measurements and conditions that may not be therapeutically significant. The disappointment of patient-participants is not the result of awrong inflicted on them; they are frustrated in not receiving a potential cure, but they were permitted to have the drug for the purpose of research - the [M.D. Anderson Cancer Center's] purpose not theirs. They were the incidental, gratuitous beneficiaries of the research... Research is not standard; it is speculation, approximation, and inquiry.55 Once courts appreciate this distinction, it becomes evident that standard medical tort doctrines must be modified to accommodate the special features of research. Four will be considered here. The first two, negligence and breach of fiduciary duty, will be discussed in the next section. Informed consent and battery, the dominant causes of action in research abuse, will receive special attention in the following section. Across this spectrum, the message is not that research injuries are somehow worse (or "better") than medical malpractice, or that we need to augment (or diminish) the available causes of action against research errors. The message is simply that research is different, and that courts need to be more knowledgeable and to think more clearly if they are to build an adequate foundation by which to guide conduct in this increasingly important realm. Adapting Causes of Action to the Research Context Negligence At the outset we should acknowledge that even the most cutting-edge research often features elements of ordinary care, which as such should be addressed under the doctrines of routine medical malpractice. If a surgical procedure is involved, for example, it must be performed with standard techniques of antisepsis, the failure ofwhich would be ordinary malpractice even if the surgery itself is experimental. Innovation, too, should generally fall under ordinary malpractice standards, which accommodate variations in care via the doctrines of reputable minorities, physician's best judgment, and other avenues for fle~ibility.~~ When research injuries are pursued as negligence torts, a major THE JOURNAL OF LAW, MEDICINE B ETHICS

4 E. Haavi Morreim shift must be recognized. As in all tort litigation, three elements must be satisfied: duty of care, injury, and causation. However, in research litigation, special attention must be directed toward the first element, the standard of care the investigator owes the research subject. For research, that duty diverges strikingly from ordinary medicine, both in its content and its sources. The standard of care for medical practice emphasizes conformity to customary and prevailing practices, even while it accommodates variations.57 In contrast, research cannot be judged by its conformity to customary practice since it is, by definition, an express deviation from those routines, taken to gather generalizable knowledge. Instead, research must first be judged by its guiding protocol. An acceptable research protocol should satisfy the criteria of ethically and scientifically sound research, including scientific merit (i.e., avaluable scientific question and valid research methods), risk minimization, and a favorable risk-benefit ratio in which risks to participants are justified by the anticipated benefits of the If the protocol is acceptable, investigators research duty of care in implementing it should include three elements. First, the investigator must enroll only eligible subjects. Enrolling ineligible people can endanger those individuals, compromise the scientific integrity of the study and thwart its hoped-for benefits to future populations. Second, the investigator should honor enrollees individual needs via whatever flexibility the protocol affords for individualizing care or, if necessary, by removing from the study any subject who is suffering undue harm. Some of the cases discussed above exhibit deficiencies of this sort. In Ken~ke?~ researchers arguably should not have kept a schizophrenic patient in the study when his depression, psychosis, and side-effects grew markedly worse. Similarly, in Burton u. Brooklyn Doctors Hospital,6o a premature infant was kept in a study evaluating the effects of high-dose oxygen on vision even after it had become clear the infant s eyes were becoming damaged. Third, the research duty of care requires stopping an entire study if its harms to enrolled subjects have become unacceptable in light of anticipated benefits. Many higher-risk studies have Data and Safety Monitoring Boards (DSMBs) to assess research results at various intervals to determine whether a study must be stopped or modified.61 Those that do not should at least have a monitoring plan that can trigger review if accrued results reveal significant problems. As research cases are adjudicated according to these distinctive duties of care, another difference with medical malpractice will emerge. While the latter is fleshed out by expert witnesses from the medical profession, the specifics of research duties must come from different sources. One major source is regulatory?2 The Federal government s Common Rule governs most human subjects research, and IRBs must ensure each project under their purview follows those rules.63 However, federal regulations do not currently govern all human research, * and they only cover certain kinds of conduct, such as informed consent, not the entire range of conduct and care appropriate for research. Hence, courts must also include other sources for defining investigators duties to their subjects. The broader scientific community may play an important role, such as to define what constitutes sound scientific methodology. Additionally, the bioethics community may help to identify what kinds of risks are acceptable, and which may be too great to impose on human subjects. Courts may introduce their own criteria if, for instance, they find that an IRB has approved an unreasonably dangerous study. Even if only rarely, courts do sometimes supplant otherwise-applicable tort standards with their own j~dgments.6~ In sum, the substantive duty of care that physician-investigators owe their research subjects begins with familiar medical malpractice doctrines, because clinical research has elements of ordinary medical practice. However, conduct that is distinctive to research should be litigated under a research-focused standard of care. Breach of Fiduciary Duty Investigators Are Not Fiduciaries Research likewise diverges markedly from ordinary medicine in the applicability of fiduciary doctrines. To be sure, the concept of fiduciary is not entirely clear, 6 and the standard physician-patient relationship is not always deemed fiduciary in the most classic ~ense.~7 Courts have been reluctant, for instance, to permit breach of fiduciary duty as a separate cause of action against a physician.68 Nevertheless, courts have felt free to call the physician-patient relationship fiduciary or at least a relationship of trust and The physician has knowledge and skills whose application require discretion, and for which the patient has significant need.7o The physician voluntarily undertakes to act primarily for the benefit of the ~atient.7~ Classic fiduciaries loyalty duties apply, such as to refrain from exploiting the latter s vulnerability for his own gain and to avoid conflicts of interest wherever p0ssible.7~ In sharp contrast, the very nature of research precludes a fiduciary relationship between investigators and subjects. By definition the researcher s goal is not the betterment of any particular participant. It is the successful completion of the research, in hope of helping future patients. This is not a situation in which a standard fidelity obligation requires a transient compromise, such as a decision whether to violate patient confidentiality to warn a third party that the patient poses a danger. Rather, a completely different allegiance permeates the relationship. The investigator s entire purpose, his number one loyalty, is already pegged on something other than the patient. It is to the protocol. To conclude that the investigator-subject relationship is not and cannot be fiduciary is sharply at odds with prior commentators. Angela Holder, for instance, argues that because investigators must treat enrolled subjects with great care, deference, andloyalty, then the relationship must be fiduciary. She further suggests that, since courts are unlikely to excuse injury and unfairness to research participants on the ground that the investigator is not a fiduciary, thii must be reason to conclude that the investigator is indeed a fiduciary. Such reasoning runs backwards. Whereas the logical chain of reasoning says that a fiduciary relationship must exist before fiduciary duties can be imposed, Holder reasons in the opposite direction, moving from the fact that investigators have duties to subjects, to infer that the relationship must therefore be fiduciary. There are two problems with this argument. First, it commits a classic logical fallacy called affirming the consequent. One begins with the premise if A is true, then B is true. If one then conversely reasons that because B is true, then A must also be true, he is committing the fallacy. Example: it is clearly true that if(a) it is raining heavily, then (B) the sky must be cloudy. However, the reverse order is not necessarily true: if (B) the sky is cloudy, then (A) it must be raining heavily. Second, Holder is simply incorrect to suppose that the duties owed by an investigator to a subject are fiduciary kinds of loyalty, As argued above, they are not. The investigator does not owe his top loyalty to the subject in the same way a physician owes his to the patient. The investigator must focus on the protocol, even if he must also take great care not to harm individual patients in the pr0cess.7~ This care, as noted, is a side-constraint - a limit on what he can do in pursuing the protocol - not the central focus of his activity. Nevertheless, even if not fiduciary in nature, investigators do have important duties toward their subjects. Arguably, those duties begin with the standard of care discussed above under negligence. Additionally, they include informational obligations, such as to make it clear that the relationship is not a traditional physician-patient kind of relationship. The investigator must emphasize to a prospective subject that the research does not aim to benefit him or her personally, that the researcher has only limited control over what will happen, NATIONAL HEALTH REFORM AND AMERICA S UNINSURED FALL

5 INDEPENDENT and will have limited options to modify the In undisclosed research, doctrine evolved away from battery during protocol to suit that patient s needs and pref- the 1960 s and 70s when courts decided that, erences. Because the investigator does not very distinctive kind Of so long as the patient gave some sort of concarry a primary loyalty to the subject, these substitution takes place, sent, then inadequacies of disclosure such as disclosures have more the character of caveat failing to mention a particular risk must be arguably even offensive emptor than a preservation of fidelity, with addressed as negligen~e.~~ After all, the con- the goal of empowering the subject with suf- than medical battery. sequences of litigating under battery could Physician-Fiduciaries as Investigators Notwithstanding the foregoing, fiduciary duties can nevertheless be present in the research setting. We must distinguish two situations: a pure research setting in which the patient s only relationship with the investigator is as a research subject, and a mixed situation in which a standard physician-patient relationship adds a research component. The former situation does not carry fiduciary duties, but in the mixed setting, a physician in a familiar fiduciary relationship adds an investigator-subject relationship. It is a situation harboring substantial hazards, with abundant opportunities for the very problems that fiduciary duties are designed to c0mbat.7~ Moore v. Regents76 illustrates the difficulties of such a mixed relationship. Since John Moore and Dr. Golde began with a standard physician-patient relationship to treat Moore s leukemia, Golde clearly owed Moore the same fidelity any physician owes his patient. Golde s surreptitious use of Moore as research fodder was thus a rank violation of his most fundamental ob1igations.n It was not merely a conflict of interest, but a fundamental change of priorities that took place without informing the patient. In contrast, had the relationship begun and continued as solely a research relationship, it would not have been fiduciary. Moore would have known that the periodic removal oftissue samples was research, because the entire relationship would have been based on that purpose. At the very least, careful disclosures seem imperative. Since a physician-investigator is ineradicably in a potential conflict between his obligation to honor the protocol and his duties to the patient, he must explain that within the ambit of the research, the investigator s first loyalty must be to the protocol, even if he shall also use any permissible leeway to accommodate that patient s individual needs.tb Another form of protection may be to engage a neutral discloser 79 or research subject advocateso to provide the information for people considering whether to enroll or continue in their physician s research. In sum, when physician-fiduciaries add investigator to their relationship with patients, breach of fiduciary duty could be a readily available cause of action if they do not manage carefully their conflicts of interest and of obligation. Battery and Informed Consent The most prevalent problems in research have stemmed from the consent process. In the earliest lawsuits the problem was a complete lack of information and consent - classically, battery. More recently litigants claim that information has been inadequate rather than absent. Both these scenarios deserve special attention. Butte y When research is surreptitious and completely unconsented, as in the government-sponsored radiation studies during the mid-twentieth century, then battery - defined as unconsented, offensive touching,s1 - seems an obvious claim. Yet courts permit only limited room for this tort in health care, particularly when they view research injuries as simply a form of medical malpractice. As argued just below, however, certain kinds of research conduct should be deemed a distinctive kind of battery, here dubbed medical research battery. Historically, informed consent doctrine began in battery, focusing on surgeries to which the patient had not consented, or which went well beyond the agreed-on procedure.82 However, informed consent single risk, the physician would in essence be accused of a crime or, at the least, of an intentional tort for which malpractice insurance provided no coverage. Battery can also carry costly punitive damagesf5 Moreover, battery requires no expert testimony, no finding that the procedure was performed negligently,86 and no causal connection between the battery and the injurie~.~7 One need only prove the touching was uncon- sented and offensive. Following that transition, many courts have been reluctant to find a cause of action for battery in health care - even where a plaintiff was ostensibly subjected to undisclosed research - so long as there was some sort of consent. Thus, in Heinrich v. Sweeps the court denied a claim for battery. The plaintiffs did not contend there was no consent at all, rather that the consent was inadequately informed, hence a matter of negligence rather than battery. Nevertheless, battery still has a role.89 Courts commonly recognize a medical battery action in three main scenarios. The first is a complete lack of consent. For instance, when pregnant women were given DES (diethylstilbestrol) to prevent miscarriage without their knowledge or consent, ultimately leaving their daughters at higher risk for cancer, a federal district court was willing to find battery even though the women themselves were not injured. The essence... [ofthe] question in a battery case involving a physician is what did the patient agree with the physician to have done, and was the ultimate contact by the physician within the scope of the patient s ons sent,''^^ Second, battery has been found where a procedure is substantially different from or beyond that to which the patient consented (in essence, a substitution of one treatment for another). In Karl. J. Pizxalotto, M.D., Ltd. v. Wi2son,g1 for instance, a patient had agreed to conservative surgery but instead received an unwanted, unconsented hy~terectomy.9~ Third, courts are willing to find battery when a different doctor is substituted for the one the patient agreed would perform the procedure ( ghost surgery ). Thus, when a patient s kidney stone surgery was performed by a different doctor in the physician s medical group the New Jersey Supreme Court held that the substitution constituted battery.g3 These latter two scenarios, in which something to which the patient did not consent is substituted for something to which he did consent (different procedure, different doctor), emphasize that battery is a matter of agreements and boundaries. The consent marks a boundary, outside of which the physician may not go without further consultation and agreement. In undisclosed research, a very distinctive kind of substitution takes place, arguably even more offensive than medical battery. It is a substitution of goals. Clinical research pursues a fundamentally different goal from ordinary medical care. While medical practice seeks to benefit the individual patient, research seeks scientific knowledge. Therefore, when patients are subjected to research without their knowledge or consent, the investigator has covertly made a profound change of goals. While the patient believes his personal welfare is the primary goal, the real goal is now to benefit society by following a protocol, even sometimes contrary to the patient s best interest. At the same time the physician has also shifted his relationship with the patient from a fiduciary physician-patient relationship to a nonfiduciary investigator-subject connection. Accordingly, where research is substituted for or added to treatment and the investigator 478 THE JOURNAL OF LAW, MEDICINE & ETHICS

6 E. Haavi Morreim has not clearly informed the patient, courts should recognize medical research battery as a cognizable a cause of action with the full panoply of battery damages, including punitive damages.g4 As a practical matter, batterywill probably remain limited as an avenue of tort remedy, even in research. First, in the current era, a complete failure to inform someone that he has been participating in research is probably relatively rare. Between the recent spate of lawsuits and the flurry of government penalties for regulatory missteps, the research community has become keenly sensitized to the importance of information and consent. Still, some areas are not so well-marked. Surgical specialties, for instance, could come under increased scrutiny. Because surgical procedures and off-label uses of approved drugs and devices are not regulated by the Food and Drug Administration (FDA)?5 it is sometimes difficult to distinguish between an innovation that is repeated for a number of patients and then evaluated by retrospective chart review (not regarded as research in federal regulation~g~) versus research. As litigators and the public become more sensitized to the thinness and ambiguity of this line, it would not be surprising to see surgical specialties come under increasing scrutiny and, in some instances, be accused of undertaking research without proper IRB and informed consent procedure^.^^ Informed Consent Currently the most prevalent complaints about research concern inadequate, not absent, information. Breach of informed consent applies when a researcher has openly invited someone to enter a research protocol but insufficiently described its nature, uncertainties, risks or alternatives. Admittedly, conceptual distinctions are not tidy. If the disclosure significantly understates the extent to which the care is protocol-governed for data-gathering purposes, for instance, or fails to describe viable standard treatment options, it could be a covert attempt to nudge the person to enroll - potentially battery. Aside from such relatively uncommon scenarios, breach of informed consent will be the leading complaint in the research setting. However, an informed consent tort for research cannot be simplistically imported from conventional medical malpractice doctrine. Each of the standard elements of negligence - breach of the duty of care, injury, and causality - must be substantially overhauled. Duty of Care: Scope of Disclosure For ordinary medical care, states establish physicians duty of disclosure in one of two ways. The older approach focuses on physicians prevailing practices, as established by expert testimony. About half the statesg8 have adopted a newer standard based on patients information needs.g9 Although patient-focused, the latter standard does not look to the vagaries of what any specific patient would want to know. Rather, nearly all states embrace an objective standard: what would the reasonable and prudent patient in similar circumstances want to know.lo0 Research requires a sharply different approach. A physician-based standard could expect little or no disclosure, if physicians prevailing practice were to conceal information. The reasonable patient has little applicability because the decision to enter research is highly individual. Research does not aim to benefit any particular patient, and people can have a wide variety of reasons for entering research, from altruism to financial gain to a desperate, last-ditch hope for cure. The Belmont Report came to the same conclusion back in 1979, finding both the conventional disclosure standards insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. lol Accordingly, research should require a distinctive standard of disclosure. It must begin by describing basic features of research. Per the Belmont Report, a reasonable volunteer standard would also require telling patients clearly that the study is not geared toward their personal benefit, and that their participation would be a voluntary activity dedicated to furthering scientific knowledge.lo2 Second, many of the particulars that must be disclosed would be identified according to regulatory requirements, including the purposes, duration and procedures of the research; any reasonably foreseeable risks or discomforts; potential benefits to the enrollee or to others; available alternatives to the research trial; and other information.lo3 Tort law should arguably expect those requirements to be met whether or not the research project in question is technically subject to federal regulation. Third, the disclosure standard for research should include a subjective element in deference to individuals varying needs for personally important information, as by inviting prospective enrollees to ask questions. To balance subjects need for personalized disclosure with investigators need for clear expectations, the research standard of disclosure might feature a rebuttable presumption. The information provided on the consent form should be presumed adequate except where the prospective enrollee has explicitly asked for additional information, as where a Jehovah s Witness might ask about the use of blood products. Once the physician is explicitly on notice that a particular kind of information is important to the prospective participant, his duty of disclosure would expand to encompass it. This rebuttable presumption will prove important in assessing causality, below. Injury In the medical malpractice realm, a physician s failure to inform is not of itself a tort unless that failure leads to a separate injury, usually though not always some physical damage that would have been averted had the physician disclosed adequately. Standard medical malpractice litigation accepts diverse kinds of injury, such as fraud, O* wrongful death, loss of consortium, and the like. These should, of course, be equally available for research litigation where applicable. The more interesting question is whether special kinds of injuries should be recognized in the research setting. Arguably, existing tort law is inadequate to identify some kinds of injuries that may be especially important in the research setting. After all, so long as courts regard breach of informed consent in research to be simply another instance of informed consent as a medical malpractice tort, they will only recognize the injuries familiar in medical malpractice actions. Medical malpractice ordinarily requires some sort of physical harm to conclude that a remedy is warranted. Many jurisdictions recognize a few non-physical injuries, such as emotional distress, but often even these must be linked to a physical injury or the threat of one.lo5 On this approach, if a duped or ill-informed research subject does not incur physical or standard harms, there is no tort. Yet in research such limits would seem inappropriate. John Moore, 06 duped into David Golde s lucrative research agenda, did not suffer significant physical harm. Yet he was profoundly wronged. Courts need to recognize that certain kinds of mistreatment in the research context can be injuries in themselves, quite regardless whether they cause further physical or other damage.?kro potential avenues are of special interest. Intentional or negligent infliction of emotional distress, aside from actual or threatened physical harm, is one possibility, particularly where the research enrollee has been duped into the research project. Courts have acknowledged emotional distress damages in research case~ ~7 and in some battery cases.108 But they may be prepared to go further. Wrongful birth case law, for instance, supports emotional distress damages for a failure to provide adequate information and choice in research. In Berman v. Allan109 an obstetrician s failure to inform a pregnant woman about the option of amniocentesis led to the birth of a child with Down s Syndrome - a child whose birth would have been averted, had the mother been informed in time to terminate her pregnancy. The court denied claims for wrongful life NATIONAL HEALTH REFORM AND AMERICA S UNINSURED FALL

7 INDEPENDENT and wrongful birth, but accepted an emotional distress claim, tied to a violation of the parents autonomy. In failing to inform Mrs. Berman of the availability of amniocentesis, defendants directly deprived her - and, derivatively, her husband - of the option to accept or reject a parental relationship with the child and thus caused them to experience mental and emotional anguish upon their realization that they had given birth to a child afflicted with Down s Syndrome?lo Arguably, if the decision whether to bring a pregnancy to term is sufficiently important for the deprivation of choice to warrant emotional distress damages, so might be the deprivation of a decision whether to participate in research. In a second avenue, courts would directly embrace dignitary torts in the research context. Even for ordinary medical care, a number of scholars have recommended that serious deficiencies of informed consent be deemed a distinct dignitary tort. Because standard informed consent doctrine limits recovery to cases featuring a physical or other separate injury, it can fail to honor human autonomy in cases where someone s right to choose has been abused without demonstrable physical damage?i2 A particularly poignant illustration comes from people who are imminently dying, because a requirement of physical injury would be virtually impossible to satisfi. In Heinrich v. Sweet the First Circuit ultimately determined that people with terminal brain cancer had no cause of action for wrongful death when they were allegedly subjected to experimental radiation treatments. After all, there was no evidence that the experiment hastened these patients already-imminent death^."^ In cases like this, where the only documentable harm is deprivation of the right to make an informed choice, the denial of a dignitary tort as a separate cause of action effectively precludes recovery - no harm, no foul. There is some evidence that courts might evolve toward dignity torts, at least in the more egregious cases. In one case a surgeon simply ignored his promise to use a specific surgical technique the patient had requested, and state statute required the Louisiana Supreme Court to deny battery. Nevertheless, the court held that [tlhe doctor s breach of duty caused plaintiff to undergo a medical procedure to which the patient expressly objected and for which the doctor failed to provide adequate information in response to the patient s request, thereby causing damages to plaintiffs dignity, privacy and emotional well-beingdn this type of case, damages for deprivation of self-determination, insult to personal integrity, invasion of privacy, anxiety, worry and mental distress are actual and compensato ry... The primary concern in this injury to the personality is vindication of valuable, though intangible, right, the mere invasion ofwhich constitutes harm for which damages are re- ~overable ~~* If such a dignitary tort can be found in ordinary medical care, surely it should be even more readily available in research, where a person seeking help for his illness can 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 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 de- livery 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 consid- 480 THE JOURNAL OF LAW. MEDICINE & ETHICS

8 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 ideas developed in alargerwork, Medical Research Litigation and Malpractice Tort Doctrines: Courts on a Learning Curve, Houston Jouml ofhealth Law and Policy 4, no. 1 (2003). Substantial portions of this article were completed while the author was Visiting Scholar at the Institute for Medical Humanities, University of Texas Medical Branch. The author acknowledges with gratitude the very helpful comments provided on earlier drafts by Joan Krause, J.D., Peter Jacobson, J.D., M.P.H., Kendra Dimond, J.D., Lance Stell, Ph.D., Jerry MenikoR, M.D., J.D., Ed Richards, J.D., M.P.H., William Winslade, J.D., Ph.D. References 1. T. Abate, Rules for Clinical Rials are Confusing, Inconsistent, San Fmncisw Chronicle, August 5,2002, at A-1, available at <http://www.sfpate.cm /cgibin/article.cgi?f=/c/a/2002/o8/05/mn4~42o.dtl~. 2. K. Morin, H. Rakatansky, FA. Riddick, L.J. Morse, et al., Managing Conflicts of Interest in the Conduct of Clinical Rials, JAMX 287 (2002): 78-84, at L. Noah, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, American Journal of Law & Medicine 28 (2002): , at J.E. Klein and A.R. Fleischman, The Private Practicing Physician-Investigator: Ethical Implications of Clinical Research in the Office Setting, Hnstings Center RepoTt32, no. 4 (2002): 22-26, at The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The BelmontReport: Ethica1PrincipZe-s andguidelinea for the Protection ofhumansu6jects ofrweurch (U.S. Department of Health, Education, and Welfare, Pub. No. [OS] C1978l). 6. See B. Bdy, The Ethics of Biomedical Research: An Intmtiml Perspective (New York: Oxford University Press, 1998): at 31-54; JA. Goldner, An Overview of Legal Controls on Human Experimentation and the Regulatory Implications of Taking Professor Katz Seriously, St. Louis UniveTsity Law Journal 38 (1993): , at Ilk Rettig, The Industrialization of Clinical Research, HealthAffairs 19, no. 2 (2000): , at 130; P.E. Kalb, K.G. Koehler, Legal Issues in Scientific Research, JAVA 287 (2002): See also J.M. Oakes, Risks and Wrongs in Social Science Research: An Evaluator s Guide to the IRB, Evaluation Rewiew 26, no. 5 (2002): , at ; R Steinbrook, Protecting Research Subjects - the Crisis at Johns Hopkins, New Engl. J. Med. 346 (2002): Cases involving FCA claims in the context of research include US. ex rel. Chandler v. Hektoen Institute, 35 F. Supp 2d 1078 (N.D. Ill. 1999); US. ex re1 Chandler v. Hektoen Imtitute, 118 F.Supp.2d 902 (N.D. Ill. 2000); United States ex rel. Cantdcin v. University of Pittsbuvh, 192 F.3d 402 (3d Cir. 1999); U.Sex rel. BeTge v. Univ. ofazu, 104 F.3d 1453 (4th cir. 1998); and US. v. Regents of University of California, 912 F.Supp. 868 (D. Md. 1995). For further discussion see Kdb and Koehler, supra note 7, at K. Morin, The Standard of Disclosure in Human Subject Expehentation, Jou~l oflegalmedzcine 19 (1998): Final Repo~t of the Advisory Committee on Human Radiation hperimts, stock number (October l995); R Faden, he Advisory Committee on Human Radiation Fxperiments: Reflections on a Presidential Commission, Hastings Cate~Repd 26, no. 5 (1996): A. Dernbner, *lawsuits Target Medical Research, Boston Globe, August 12, 2002, at A-1, available at ~http://www.boston.corn/dailyglobe~/l38/ metro>; E.A. Price and J.A. Lemons, Clinical Rials: Protecting the Subject, Avoiding Liabdity, and Managing Risk Health Law Egest Analg& , no. 1 (2002): 3-13, at 8-9; Grimes v. Kennedy Krieger, 782 k2d 807, (Md. 2001). 12. Goldner, supra note 6, at U. S. v. Stanley, 107 S.Ct (1987). LSD, or lysergic axid diethylamide, is an hallucinogenic drug. 14. Jdee v. United States, 663 F2d 1226 (3rd Cir. 1981), cert. denied, 102 S.Ct (1982). See also Begay v. United States, 768 F.2d 1059 (9th Cir. 1985); Scottv. Casey, 562 FSupp. 475 (N.D. Ga. 1983). 15. Final Report of the Advisory Committee on Human Radiation Experi- ments, supra note In re Cincinnati Radiation Litigation, 874 FSupp. 796 (S.D. Ohio l995). 17. Stadt v. University of Rochester, 921 F.Supp (W.D.N.Y. 1996). See also Barrett v. United States, 689 E2d 324 (2d Cir. 1982). 18. Heinrich v. Sweet, 44 F.Supp.2d 408 (D. Mass. 1999) (Heinrich I); Heinrich v. Sweet, 49 F.Supp.2d 27 (D. Mass. 1999) (Heinrich II); Heinrich ex rel. Heinrich v. Sweet, 62 F.Supp.2d 282 (D. Mass. 1999) (Heinrich III). Interestingly, the First Circuit presents a markedly different description of the facts. Per a jury verdict that found for the defendants on the informed consent issue, the First Circuit describes an effort to bring conscientious science to dying people who were fully informed that it was experimental and risky. Yeinrich v. Sweet, 308 F.3d 48 (1st Cir. 2002) (cert. denied June 9,2003) 19. Hyman v. Jewish Chronic Disease Hospital, 251 N.Y.S.2d 818 (N.Y.App.2 Dept. 1964); rev d, Hymanv. Jewish Chronic Disease Hospital, 206 N.E.2d 338 (N.Y. 1965). 20. Heinrich ex re]. Heinrich v. Sweet, 62 F.Supp.2d 282 (D. Mass. 1999) (Heinrich III). See also Anderson v. George H. Lanier Memorial Hosp, 982 F.2d 1513 (11th Ci. 1993); Barrett v. United States, 689 F.2d 324 (2d Cir. 1982); Mink v. University of Chicago, 460 F.Supp. 713 (N.D. Ill. 1978); Bibeauv. Pacific Northwest Research Foundation, 980 FSupp. 349 (D. Or. 1997); Craft v. Vanderbdt Univ., 18 F.Supp.2d 786 (M.D. Tenn 1998). 21. In re Cincinnati Radiation Litigation, 874 FSupp. 796, 807 (S.D. Ohio 1995) (referring to 42 U.S.C ). See also Barrettv. United States, 689 E2d 324,330 (2d Cir. 1982). 22. Mink v. University of Chicago, 460 ESupp. 713 (N.D. Ill. 1978). 23. Karp v. Cooky, 349 F.Supp. 827 (S.D.Tex 1972), ad, 493 F.2d 408 (5th Cir. 1974). 24. Burton v. Brooklyn Doctors Hospital, 452 N.Y.S.2d 875 (N.Y. App. Div. 1982). 25. Burton v. Brooklyn Doctors Hospital, 452 N.Y.S.2d 875 (N.Y. App. Div. 1982). See also Anderson v. George H. Lanier Memorial Hnsp, 982 F.2d 1513 (11th Cir. 1993); Friter v. IOLAB Corporation 607 A. 2d 1111 (Pa. Super. 1992); Kus v. Sherman Hospital, 644 N.E.2d 1214 (Ill. App. 2 Dist. 1995) (using experimental intraocular lens implants on poor, uneducated patients). 26. Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990), cert. denied, 112 S. Ct (1992). 27. Grimes v. Kennedy Krieger, 782 A.2d 807 (Md. 2001). 28. See also Kernkev. The Menninger Clinic Inc., 172 F.Supp.2d 1347 (D. Kan. 2001); Andev. Rock, 647N.W.2d 265, (Wis. App. ZOOZ), cert. denied, 650 N.W.2d 840 (Wis. 2002); cert. denied (sub. nom. Ande v. Fost), 123 S.Ct. 883 (2003). 29. The cases include Gelsinger v. hstees ofthe University of Pennsylvania; Adennan v. mutees ofthe University of Pet~n~~lda, Robertson v. McGee, Berman v. Fred Hutchinson Cancer Research Center, Wright v. Fred Hutchinson Cancer Research Center, Guckin v. Nagle, Dagosto v. Fred Hutchinson Cancer Research Center, and Lett v. Board of Regents of the Ohio State University. As of October 2002, complaints in these and other cases were available at<www.sskrplaw.com>. See also Price and Lemons, supra note 11, at Noah, sum note 3, at See E. H. Morreim, A Dose of Our Own Medicine: CAM, Conventional Medicine, and the Standards of Science,* Journal of Law, Medicine 9 Ethics 31 (2003): ; E.H. Morreim, Professionalism and Clinical Autonomy in the Practice of Medicine, Mt. Sinai Journal ofmedicine 69, no. 6 (2002): See J.B. Moseley, K. O MalIey, N.J. Petersen, T. Menke, BA. Brody, D.H. Kuykendall, J.C. Hollingsworth, C.M. Ashton, and N.P. Wray, A Controlled?lid of Arthroscopic Surgery for Ostenarthritis of the Knee, New Eng1.J. Med. 337 (2002): 81-88; D.T. Felson and J. Buckwalter, Dkbridement and Lavage for Osteoarthritis of the Knee, New Engl. J. Med. 347 (2002): See R Levine, Clarifying the Concepts of Research Ethics, Hastings Center Report 9, no. 3 (1979): 21-26, at 22; Noah, supra note 3, at 373, S. Horng and F.G. Miller, Is Placebo Surgery Unethical? New Engl. J. Med 347(2002): , at 137; S.M. Grunberg and W.T. Cefah, The Integral Role of Clinical Research in Clinical Care, New Engl. J. Med. 348 (2003): , at R Levine, Clarifjmg the Concepts of Research Ethics, Hastings Center Report 9, no. 3(1979): 21-26; K. Morin, The Standard of Disclosure in Human Subject Experimentation, The Journal of Legal Medicine 19 (1998): , at Goldner, supra note 6, at F.G. Miller and D.L. Rosenstein, The Therapeutic Orientation to Clinical Mals: New Engl. J. Med. 348 (2003): , at 1383; P.S. Appelbaum, LH. Roth, C.W. Lid& P. Benson, and W. Wmlade, False Hopes and Best Data. Consent to Research and the Therapeutic Misconception, Hastings Center Report 17, no2 (1987): 20-24, at 21; F.G. Miller and H. Bdy, A Critique of clical Equipoise: Therapeutic Misconception in the NATIONAL HEALTH REFORM AND AMERICA S UNINSURED FALL

9 INDEPENDEN1 Ethics of Clinical Trials, Hastings Center Report 33, no. 3(2003): 19-28, at 22; N.M.P. King, Defining and Describing Benefit Appropriately in Clinical Trials, Journal oflaw, Medicine 9 Ethim 28 (2000): , at 339; J. Katz Human Experimentation and Human Rights, St. Luuis Law Jouml38 (1993): 7-54, at 34; K. Morin The Standard of Disclosure in Human Subject Experimentation, The JuumZofLegaZMedicine 19 (1998): , at 221; RJ. Levine, Uncertaintyin Clinical Research, Law, Medicine 9 Health Care 16 (198): , at ECRI, Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-threatening Illness, (ERCI, February 2002), at 33; Miller and Rosenstein supra note 37, at 1383; Miller and Brody, supra note 37, at 21-22; L.R Churchill, D.K. Nelson, G.E. Henderson N.M.P. King,A.M. Davis, E. Leahey and B.S.Wilfond, Assessing Benefits in Clinical Research: Why Diversity in Benefit Assessment Can he Risky, IRB: Research 25, no. 3 (2003): 1-8, at 3. But see J.M. Peppercorn, J.C. Weeks, E.F. Cook and S. Joffe, Comparison ofoutcomes in Cancer Patients hated Within and Outside Clinical Trials: Conceptual Framework and Structured Review, Lancet 363 (2004): T. Abate, Rules for Clinical Mals are Confusing, Inconsistent: No Single Agency Regulates Medical Research on Humans, Putting Millions ofvolunteers at Risk, San Francisco Chmic.k,August 5,2002, at A-1, available at ~http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a~2002/08/05~mn DTL>. 40. See P.S. Appelbaum, C.W. Lidz, and A. Meisel, Inznned Consent: Legal Theory and CZinicaZPractice (New York: Oxford University Press, 1987), at ; Appelbaum, supra note 37, at 20-21; P.S. Appelbaum, L.H. Roth, and C. Lidz, The Therapeutic Misconception: Informed Consent in Psychiatric Research, International JounaZ of Law 9 Psychiahy 5, no. 3-4 (1982): , at ; C. Fried, MedicaZEzpm mentation: Personalhtegrity and SociaZPoZicy (New York: American Elsevier F ublishing Col, Inc., 1974), at R. Nozick, Anarchy, State, and Utopia (New York: Basic Books, Inc., 1974), at 29, As noted by Miller and Brody, this view contrasts with an alternative in which the researcher is thought to owe his patient the best available treatment. Miller and Brody, supra note Goldner, supra note 6, at Fortner v. Koch, 261 N.W. 762,765 (Mich. 1935). 45. Moore v. Regents of the University of California, 793 P.Zd 479 (Cal. 1990), cert. denied 112 S. Ct (1992). 46. Id., at 481. See also Moore v. Regents of the University of California, 249 Cal. Rptr. 494,500 (Cal. App. 2 Dist. 1988). 47. Moore was diagnosed in Other than splenectomy, only symptomatic treatments were available until 1984, when interferon-alpha became available. See H.M. Golomb and J. Vardiman, Hairy-cell Leukemia, in R.C. Bast, D.W. Kufe, R.E. Pollock, R.R. Weichselbaum, J.F. Holland, and E. Frei, Holland 9 Fra : Cancer Medicine, 5th ed. (Hamilton, Ontario: B.C. Decker Inc., 2000): Almost none of the various tissues Golde harvested from Moore could even be usedto monitor his wellbeing, because remissions in the splenectomy series are defined solely by improvement in peripheral blood cytopenias. Id. at ARerthe operation, Moore recover[ed] fromthe symptoms [he] had exhibited before.... Despite Moore s apparent recovery, Golde requested that Moore continue to see him periodically so that [Golde] could continue to check up on the condition of the disease. Moore traveled from his home in Seattle to Los Angeles approximately twelve times to visit Golde who, on each occasion, withdrew samples of blood, blood serum, skin, bone marrow aspirate, and sperm. During this time, Golde and his research assistant were conducting research on Moore s cells and planned to benefit financially and competitively by exploiting the cells and their exclusive access to them by virtue of Golde s ongoing physician-patient relationship with Moore. H.R. Bergman. Case Comment: Mwre v. Regents ofthe University of California, American Journal of Law 9 Medicine 38 (1992): , at Moore, at one point, mentioned that he could not afford to continue to travel to Los Angeles and suggested that he obtain his continuing care in Seattle. In response, Golde told Moore that he would obtain grant funds to pay for Moore s trips. Later, when Moore expressed concern about the cost of accommodations, Golde offered to pay Moore s expenses at a luxurious hotel in Beverly Hills. On the first trip thereatter, Golde presented Moore with a very elaborate and very complicated consent form purporting to give away the rights to [the] cell line and products derived therefrom. Unaware of Golde s development efforts, Moore signed the form giving his consent. On his next and last visit, Golde again asked Moore to sign a form. Moore, believing that Dr. Golde s answers to his questions were vague and...quite patronizing, signed the form explicitly withholding his consent by circlingaboxmarked I do not consent. Moore became suspicious and contacted an attorney as Golde repeatedly tried to persuade Moore to sign the form in the correct fashion. Moore subsequently filed suit against the Regents, as patent holders, and against Golde and his research assistant. Id. at A federal court recently defined medical treatment as actions... taken in an effort to benefit or cure the patient. Craft v. Vanderbilt Univ., 18 F.Supp.2d 786,796 (M.D. Tenn 1998); see also Payette v. Rockefeller University, 643 N.Y.S.2d 79 (App Div 1 Dept. 1996). 50. Bergman, supra note 48, at Kernke v. The Menninger Clinic Inc., 172 F.Supp.2d 1347 (D. Kan. 2001). 52. Id. at 1354; See also Heinrich ex rel. Heinrich v. Sweet, 62 F.Supp.2d 282, 313 (D. Mass. 1999). 53. Payettev. Rockefeller University, 643 N.Y.S.2d 79 (App Div 1 Dept. 1996). 54. &ably, courts that equate research with ordinaqpractice labor under their own therapeutic misconception, an assumption that somehow research, simply because it involves medical interventions, must be geared toward providing direct benefit for each patient, and that therefore the proper standard for assessing research interventions must be the same as for standard medical care. See Appelbaum, et al., supra note 37; Appelbaum, Roth, and Lidz, supra note 40. Miller and Brody discuss in detail the conceptual and ethical problems inherent in seeing research as a form of therapeutic enterprise. Miller and Brody, supra note Spenceley v. M.D. Anderson Cancer Center, 938 ESupp. 398,398 (S.D. Tex. 1996). In DahZ u. HEM Pharmaceuticals Corp., 7 F.3d 1399, 1404 (9th Cir. 1993), research participants sued to receive the year s worth of drug they had been promised in exchange for participating in a study of chronic fatigue syndrome. The court found that a contract existed, and the participants were owed the drug in exchange for their contribution to the research. These patients had submitted themselves to months of periodic injections with an experimental drug, or unbeknownst to them, mere saline solution, combined with intrusive and necessarily uncomfortable testing... HEM sought to have them participate in its study so that it could obtain FDA approval for its new drug, and so the company was obligated to keep its end of the bargain. See also Barrett v. United States, 689 F.2d 324 (2d Cir. 1982); In re Cincinnati Radiation Litigation, 874 F.Supp. 796, 814 (S.D.Ohio 1995); Anderson v. George H. b ier Memorial Hosp., 982 F.2d 1513,1519 (11th Cir. 1993). 56. A.H. McCoid, The Care Required of Medical Practitioners, Vandmbilt Law Review 12 (1959): , at P.G. Peters, The Quiet Demise of Deference to Custom: Malpractice Law at the Millennium, Washington andke Law Rm ew 57 (2000): C.F.R. $46.111; Horng and Miller, supra note 34, at 137. See also E.J. Emanuel, D. Wendler, and C. Grady, What Makes Clinical Research Ethical? JAu4 283 (2000): (discussing seven criteria for ethical research: [I] value; [2] scientificvalidity; [3] fair subject selection; [41 favorable risk-benefit ratio: [5] independent review; [6] informed consent; and [7] respect for enrolled subjects). 59. Kernkev. The Menninger Clinic Inc., 172 F.Supp.2d 1347 (D.Kan. 2001). 60. Burtonx Brooklyn Doctors Hospital, 452 N.Y.S.2d 875 (N.Y.App.Div. 1982). 61. S.S. Ellenberg, T.R Fleming, and D.L. Demets, Data Monitoring Committees in Clinical 74iuls: A Pmctical Perspective (Hoboken,: John Wiley &Sons, 2002). 62. For further discussion, see B. Brody, The Ethics ofbiomedicuz Research: An IntmtionaZPerspective (New York: Oxford University Press, at Unlike research, innovation is not subject to regulation. For instance, the FDA refrains from governing off-label prescribing, a common form of innovation. See Noah, supra note 3, at 398. See also Southard v. Temple Univ. Hosp., 781 A.2d 101,104 (Pa. 2001); Blazoski v. Cook,787A.2d 910,919 (N.J.SuperA.D. 2002). 63. IRBs must ensure, for example, that risks to subjects are minimized; risks are reasonable relative to anticipated benefits: selection of subjects is equitable: informed consent is sought from each subject or legally authorized representative; informed consent is appropriately documented; data are appropriately monitored to ensure subjects safety; subjects privacy is appropriately protected; and vulnerable populations such as children and the mentally disabled are provided added levels of protection. 45 C.F.R Currently, federal regulations apply to research that receives federal funding, and to the entire spectrum of research in academic institutions that receive federal funding via multiple project assurances. Companies using their own funds to sponsor trials for FDAapproval must conform to FDA rules, which still require IRB surveillance. However, some research escapes supervision altogether. For instance, since the FDA does not require approval of new surgical procedures, or of off-label uses of drugs and devices (unless the manufacturer wants to change its labeling), research in these areas can escape supervision if it does not involve federal funding and is not undertaken at an institution that bas assured the government it will supervise all research within its walls. See generally R.A. Rettig, The Industrialization of Clinical Research, Health Aflairs 19, no. 2 (2000): , at 139; P.E. Kalb and K.G. Koehler Legal Issues in Scientific 482 THE JOURNAL OF LAW, MEDICINE & ETHICS

10 E. Haavi Morreim Research, JAMA 287 (2002): 85-91, at 87; EA. Price and J.A. Lemons, Clinical Mals: Protecting the Subject, Avoiding Liability, and Managing Risk, Health Law Digest: Digest Analysis 30, no. 1 (2002): 3-13, at Hellingv. Carey, 519 P.2d 981 (Wash, 1974); T.J. Hwper, 60 F.2d737 (2d. Cir. 1932). 66. Generally a fiduciary relationship is one in which trust and confidence are reposed by one party in the influence or dominance of another, creating in the latter a duty to act with greater diligence and care than that required by a common negligence standard of due care. W.J. Curran and G.B. Moseley, The Malpractice Experience of Health Maintenance Organizations, Northwestern University Law Review 70 (1975): 69-89, at 76. See also J.C. Shepherd, The Law of Fiduciaries (Toronto: Carswell Company Ltd, 1981); DA. DeMott, Beyond Metaphor: An Analysis of Fiduciary Obligation, Duke Law Journal 819 (1988): ; T. Frankel, Fiduciary Law: Calgornia Law Review 71 (1983): M.A. Rodwin, Conflicts in Managed Care, NewEngZ. J. Med. 332 (1995): ; MA. Rodwin, Medicine Money 9 Morals: Phyisicians CmJicts of Interest (New York: Odord University Press, 1993). 68. See, e.g., DAB. v. Brown, 570 N.W.2d 168 (Minn. App. 1997); Spoor v. Serota, 852 P.2d 1292 (Colo. App. 1992); Awai v. Kotin, 872 P.2d 1332 (Colo. App. 1993). 69. McCloud v. Seier, 567 SW2d 127 (Mo. 1978); Garciav. Coffman, 946 P.2d 216 (N.M. App. 1997); Lockett v. Goodill, 430 P.2d 587 (Wash. 1967); Miller v. Kennedy, 522 P.2d 852, (Wash. Ct. App. 1974), ad, 530 P.2d 334 (Wash. 1975); Hammonds v. Aetna Cas. & Sur. Co., 243 FSupp. 793, (N.D. Ohio 1965); Murphy v. Godwin, 303 A.2d 668 (Del. Super. 1973); Shadrick v. Coker, 963 S.W.2d 726 (Tenn. 1998); Sard v. Hardy, 379 A.2d 1014 (Md. App. 1977); Roy v. Hartogs, 366 N.Y.S.2d 297 (N.Y. 1975); Gates v. Jensen, 595 P.2d 919 (Wash. 1979); Bowman v. McPheeters, 176 P.2d 745,748 (Cal. 1947); Natanson v. Kline, 350 P.2d 1093,1101,1103 (Kan. 1960); Berkey v. Anderson, 82 Cal. Rptr. 67,77-78 (Cal. App. 2 Dist. 1969); Tighe v. Ginsberg, 540 NYS 2d 99 (1989); Mac- Donald v. Clinger, 446 NYS 2d 801 (1982); Wohlgemuthv. Meyer, 293 P.2d 816 (Cal. App. 1 Dist. 1956); Moore v. Regents ofthe Univ. of Cal., 793 P.2d 479,483 (Cal. 1990); Petri110 v. Syntex Laboratories, Inc., 499 N.E.2d 952 (111. App. 1 Dist. 1986); bwnsbury v. VanBuren, 762 N.E.2d 354 (Ohio 2002). 70. The United States Supreme Court has noted that the central purpose of fiduciarylaw is to govern the exercise ofdiscretion in making decisio nsthat are not, and cannot be, controlled in advance by legal means. P.D. Jacobson and M.T. Cahill, -Applying Fiduciary Responsibilities in the Managed Care Context, Amm can Journal oflaw Medicine 26 (2000): , at That is, a fiduciary relationship does not arise simply because one person needs or chooses to trust another, but because the latter agrees to this distinctive kind of arrangement. We have said that [fliduciary duty is not created by a unilateral decision to repose trust and confidence; it derives from the conduct or undertaking ofthe purported fiduciary and have defined a fiduciary as [a] person having duty, created by his own undertaking, to act primarily for another s benefit in matters connected with such undertaking. Long v. Great West Life &Annuity Ins., 957 P.2d 823,829 (Wyo. 1998). See also Johnson v. Brewer & Pritchard, P.C., 73 S.W.3d 193, 200 (Tex. 2002), citing Restatement 2d. of Agency 13, cmt. a(1958); Greenberg v. Miami Children s Hospital Research Institute, 264 F.Supp.2d 1064 (S.D.Fla 2003). 72. The fiduciary is held to something stricter than the morals ofthe market place. Not honesty alone, but the punctilio ofan honor the most sensitive, is then the standard ofbehavior; the fiduciary s conduct must be kept at a level higher than that trodden by the crowd. Meinhard v. Salmon, 164 N.E. 545,546 (NY 1928). Physicians in ordinary practice cannot completely avoid conflicts of interest or of obligation. Various forms of payment bring potential conflict, for instance, whether fee-for-service (with an incentive to provide needless services) or capitation (with incentive to withhold helpful but costly services). Nevertheless, the physician must still focus on the patient s interest. 73. A.R. Holder, Do Researchers and Subjects Have a Fiduciary Relationship? IRE 4, no.l(l982): 6-7, at 6. Karin Morin also suggests that traditionally the physician-patient relationship and the investigator-subject relationship have both been described as fiduciary. K. Morin, The Standard of Disclosure in Humansubject Experimentation, JournalofLegalMedicine 19 (1998): , at 216. See also Vodopestv. MacGregor, 913 P.2d 779,788 (Wash. 1996). 74. Even the leading case emphasizing investigators duties toward subjects does not deem the relationship fiduciary, but rather a special relationship. Grimes v. Kennedy Krieger, 782 k2d 834,843 (Md. 2001). 75. Klein and Fleischman, supra note 4. See also J.E. Kass, J. Sugarman, R Faden, and M. Schoch-Spana, Trust: The Fragile Foundation of Contemporary Biomedical Research, Hastings CaterReport 26, no. 5 (1996): 25-29, at 27; D. Penman, Informed Consent for Investigational Chemotherapy: Patients and Physicians Perceptions: Joudof Clinical Oncology 2 no. 7 (1984): ; S. Rajagopal, P.J. Goodman, and I.F. Tan- nock, Adjutant Chemotherapy for Breast Cancer: Discordance Between Physicians Perception of Benefit and the Results of Clinical Mals: Journal of Clinical oncologqr 12, no. 6 (1994): Moorev. Regents of the University of California, 793 P.2d 479 (Cal. 1990), cert. denied 112 S. Ct (1992). 77. The California Supreme Court affirmed breach of fiduciary duty as a valid cause of action in this case. Id. at 483,485. See also McCall v. Pacificare of Cal., Inc., 21 P.3d 1189 (Cal. 2001). 78. While investigators also unequivocally have an obligation to minimize harm to subjects and to respect their wishes, patients who enroll as research subjects must understand this shift in loyalties that is inherent to the role of investigators, in contrast to that of patients personal physicians. Kass, et al, supra note 75, at 28; Katz, supra note 37, at 34; Goldner, supra note 6, at Appelbaum, et. al., supra note 37, at 23. Similarly, independent consent or procedure monitors have been proposed. Klein and Fleischman supra note 4, at The National Institutes of Health now requires what it calls Research Subject Advocates to be involved in all trials funded through its General Clinical Research Centers. See National Center for Research Resources, Guidelines for the General Clinical Research Centers Program (November 2001), available at ~http://www.ncrr.nih.gov/clinical/crguide~~~~/~idenov2001.pdf>, at 11. See also E.H. Morreim, By Any Other Name: The Many Iterations of Patient Advocate in Clinical Research, IRE: Ethics 9 Human Research (2004), forthcoming. 81. The law ofbattery also protects against touchingsthat are offensive, even if they do not inflict bodily harm. In so doing, battery protects the purely dignitary interest in the body that it be free from offensive contact. A. Meisel A DignitaryTort as a Bridge Between the Idea of Informed Consent and the Law of Informed Consent, Law, Medicine 9 Health Care 16 (1988): , at 211. See abo Friterv. IOL4B Corporation, 607k2d 1111, 1115 (Pa. Super. 1992); Minkv. University of Chicago, 460 F.Supp. 713,7l8 (N.D ), citing Restatement 2d. of Torts; Cardwell v. Bechtol, 724 S.W.2d 739,750 (Tenn. 1987). 82. Mohr v. Williams, 104 N.W. 12 (1905); Rolater v. Strain, 137 P. 96 (Okla. 1913); Schloendorf v. Society of New York Hospital, 105 N.E. 92 (N.Y. 1914). 83. Natanson v. Kline, 350 P.2d 1093 (Kan. 1960); Natanson v. Kline, 354 P.2d 670 (Kan. 1960); Cobbsv. Grant, 502 P.2d I(1972); Canterburyv. Spence, 464 F.2d 772 (D.C. 1972); Wilkinson v. Vesey, 295 A.2d 676 (R.I. 1972); Cobbs v. Grant, 502 P.2d 1,8 (1972). See also Meisel, supra note 81, at 211; K. Morin, The Standard of Disclosure in Human Subject Experimentation: The Journal ofkgal Medicine 19 (1998): , at 160ff.; supra note 3, at 364 E J.H. Krause, Reconceptualizing Informed Consent in an Era of Health Care Cost Containment,m Iowa Law Review 85 (1999): , at ; Goldner, supra note 6, at 74-78; Mink v. University of Chicago, 460 FSupp. 713, (N.D. Ill. 1978). 84. nogun v. Fruchtman, 207 N.W.2d 297,313 Wis. 1973). 85. Perry v. Shaw, 106 Cal.Rptr.2d 70, 73 (Cal. App.2 Dist. 2001). See also Howard v. University of Medicine, 800 A.2d 73,80 (N.J. 2002); Trogun v. Fruchtman, 207 N.W.2d 297,313 (Wis. 1973); M.M. Shultz, From Informed Consent to Patient Choice: A New Protected Interest, Yale Law Journal95 (1985): , at Grabowski v. Quigley, 684 A.2d 610,615 (Pa. Super. 1996) 87. Gouse v. Cassel, 615 A.2d 331,333 (Pa. 1992); Grabowski v. Quigley, 684 A.2d 610 (Pa. Super. 1996); Duttry v. Patterson, 741 A.2d 199,203 (Pa. Super 1999);?gylorv.Albert Einstein Medical Center, 723 A.2d 1027,1035 (Pa. Super. 1998); Krause, supra note 83, at Heinrich v. Sweet, 49 F.Supp.2d 27, 38 (D. Mass. 1999) (Heinrich II). 89. Some states, such as Pennsylvania and Tennessee, still emphasize battery as the cornerstone of the duty to disclose. See Morgan v. MacPhail, 704 A.2d 617,620 (Pa. 1997); Duthyv. Lewis T. Patterson, M.D., 771A.2d 1255 (Pa. 2001); Cardwell v. Bechtol, 724 S.W.2d 739 (Tenn. 1987); Shadrick v. Coker, 963 S.W.2d 726 (Tenn. 1998). 90. Mink v. University of Chicago, 460 F.Supp. 713 (N.D. Ill. 1978) citing Cathemerv. Hunter, 558 P.2d 975,978 (1976). See also Perryv. Shaw, 106 Cal.Rptr.2d 70 (Cal. App.2 Dist. 2001); Curtis v. Jaskey, 759 N.E.2d 962 (Ill. App. 2 Dist. 2001); Lloyd v. Kull, 329 F.2d 168 (7th Cir. 1964); Harveyv. Strickland, 566 S.E.2d 529 (S.C. 2002); Lojuk v. Quandt, 706 E2d 1456 (7th Ci. 1983), cert. denied, 106 S.Ct. 822 (1986); Graggv. Calandra, 696 N.E.2d 1282 (1U.App. 2 Dist. 1998); Robersonv. Provident House, 576 So.2d 992 (La. 1991). 91. Karl. J. Pizzalotto, M.D., Ltd. v. Wilson, 437 So.2d 859 (La. 1983). 92. Similarly, in Russell u. Muzphg, the patient expressly wanted l d anesthesia but instead received general anesthesia. Russell v. Murphy, 86 S.W.3d 745 (TexApp. 2002). See also Cobbs v. Grant, 502 P.2d 1,7 (Cal. 1972); Gaskin v. Goldwasser, 520 N.E. 1085,1094 (111App. 4 Dist. 1988); Cathemerv. Hunter, 558 P.2d975 (Ariz. App. 1976); Benton v. Snyder, 825 S.W.2d 409 (Tenn. 1992); Perin v. Hayne, 210 N.W.2d 609 (Iowa 1973); Hernandez v. Schittek, 713 N.E.2d 203 (Ill. App. 3 Dist. 1999); SchloendorfTv. Society of New York Hospital, 105 N.E. 92 (N.Y. 1914). NATIONAL HEALTH REFORM AND AMERICA S UNINSURED FALL

11 INDEPENDENT 93. Perna v. Pirozzi, 457 A.2d 431,439 (N.J. 1983). See also Pugsley v. Privette, 263 S.E.2d 69 (Va. 1980); Tom v. Lenox Hill Hosp., 627N.Y.S.Zd 874 (Sup.Ct. 1995); Curtis v. Jaskey, 759 N.E.2d 962, 965 (Ill. App. 2 Dist. 2001); Guebard v. Jabay, 452 N.E.2d 751 (Ill. App. 2 Dist. 1983); Grabowski v. Quigley, 684 A.2d 610 (Pa. Super. 1996). In some instances courts have been willing to see a physician s misrepresentation of his credentials or experience as an instance of battery. See Hales v. Pittman, 576 P.2d 493 (Ariz. 1973); Guebardv. Jabay, 452 N.E.2d 751 (Ill. App. 2 Dist. 1983); Duttry v. Patterson, 741 A.2d 199 (Pa. Super 1999); reversed, Duttry v. Lewis T. Patterson, M.D., 771 A.2d 1255 [Pa ). But see Howard v. University of Medicine, 800 A.2d 73 (N.J. 2002); Taylor v. Johnston, 985 P.2d 460 (Alaska 1999). 94. Some courts have already applied battery to the research setting. See Kus v. Sherman Hosp., 644 N.E.2d 1214,1220 (Ill. App. 2 Dist. 1995); Whitlock v. Duke University, 637 F.Supp (M.D.N.C. l986), affd, 829 F.2d 1340 (4th Cir. 1987); Friterv. I OW Corporation, 607A.2d 1111 (Pa. Super. 1992). Note that this modified battery tort would not apply to clinical innovation, which, as noted above, still focuses on the best interests of the individual. Innovation may feature significant uncertainty, and a number of courts have held that physicians should inform patients when an intervention is untested. See, eg., Gaston v. Hunter, 588 P.2d 326,351 (&. App. 1978); Ahern v. Veterans Administration, 537 F.2d 1098,1102 (loth Cir. 1976); Estrada v. Jaques, 321 S.E.2d 240 (N.C. App. 1984); Retkwa v. Orentreich, 584 N.Y.S.2d 710 (Sup. 1992); Corrigan v. Methodist Hosp., 874 ESupp. 657 (E.D. Pa. 1995); Shadrickv. Coker, 963 S.W.2d 726 (Tenn. 1998); Salgo v. Leland Stanford Jr. University Bd. ofbst., 317 P.2d 170, (Cal. 1957). But see Southardv. Temple Univ. Hosp., 781 A.2d 101, 104 (Pa. 2001); Blazoski v. Cook,787 A.2d 910, 919 (N.J. Super. A.D. 2002). See also Noah, supra note 3, at Noah, supra note 3, at 398; Southard v. Temple Univ. Hosp., 781 A.2d 101, 104 (Pa. 2001); Blazoski v. Cook, 787 A.2d 910, 919 (N.J. Super. A.D. 2002) C.F.R (b)(4). 97. In 2003, for instance, the National Naval Medical Center suspended all orthopedic and radiology research after discovering that astudy of shoulder injuries had not been submitted for IRB approval. See L.K. Altman, Naval Center Halts Research During Inquiry About Ethics, New York Times, September 28, 2003, available at <http://www.nytimes.com/ 2003/09/28/ national/28ethi.btml>. 98. Krause, supra note 83, at 314; Noah, supra note 3, at Canterburyv. Spence, 464 F.2d 772 (D.C. 1972); Cobbs v. Grant, 502 P.2d 1 (1972); Wilkinson v. Vesey, 295 A.2d 676 (RI. 1972) Not all states use this objective standard. See, e.g., Scott v. Bradford, 606 P.2d 554 (Okl. 1980). For further discussion see G.H. Morris, Dissing Disclosure: Just What the Doctor Ordered, Arieona Law Review 44 (2002): , at 331 ff U.S. Department of Health, Education, and Welfare, National Commission for the Protection of Human Subjects of Biomedical and behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection ofhumansubjects ofresearch (Pub. No. (0s) ) (1978), reprinted in B. Brody, The Ethics ofbiomedica1 Research (New York: Oxford University Press, 1998), at Id C.ER See also P.M. Bein, Surrogate Consent and the Incompetent Experimental Subject, Food Lhxg Cosmetic Law Jouml46 (1991): , at 743; Grimesv. Kennedy Krieger, 782 A.2d 807,849 (Md. 2001) See, e.g., Anderson v. George H. Lanier Memorial Hosp, 982 F.2d 1513 (11th Cir. 1993); Minkv. University of Chicago, 460 ESupp. 713 (N.D. Ill. 1978); Perna v. Pirozzi, 457 A.2d 431 (N.J. 1983) Jurisdictions differ markedly on threshold questions such as whether a physical injury or the threat of one is required. See Molien v. Kaiser Foundations Hospitals, 616 P.2d 813 (Cal. 1980); Row v. Bennett, 514 k2d 802 (Me. 1986); Willis v. Ashby, 801 A.2d 442 (N.J. Super. A.D. 2002); Perry- Rogersv. Obasaju, 723 N.Y.S.2d 28,29 (A.D. 1 Dept. 2001); Pemav. Pirozzi, 457 A.2d 431,438 (N.J. 1983); Martell v. St. Charles Hosp., 523 N.Y.S.2d 342 (Sup. 1987); Hecht v. Kaplan, 645 N.Y.S.2d 51 (A.D. 2 Dept. 1996) Moorev. Regents ofthe University OfCalifornia, 793 P.2d 479 (Cal. 1990), cert. denied 112 S. Ct (1992) See Whitev. Paulsen, 997 ESupp (E.D. Wash. 1998); In re. Cincinnati Radiation Litigation, 874 ESupp. 796 (S.D. Ohio 1995); Blanton v. United States, 428 FSupp. 360 (D.D.C. 1977); Lugenbuhl v. Dowling, 701 So.2d 447 (La. 1997) See, e.g., Perna v. Pirozzi, 457 A.2d 431,438 (N.J. 1983); Gragg v. Calandra, 696 N.E.2d 1282 (Ill. App. 2 Dist. 1998). But see Bmskav. Olson, 668 A.2d 1355 (Del. 1995). For further discussion see N. Levit. Ethereal Torts, George Washingtun Law Review 61 (1992): , at , Bermanv. Allan, 404 2d. 8 (N.J. 1979) Berman, 404 2d. at 14. See also, e.g., Mato ex rel. v. Kappy, 803A.2d 160, 166 (N.J. Super. A.D. 2002) Shultz, supra note 86; Meisel, supra note 81; Levit, supra note 109; Morris, supra note 100; Krause, supra note 83; A.J. Weisbard, Informed Consent: The Law s Uneasy Compromise with Ethical Theory, Nebraska Law Review 65 (1986): ; J. Goldstein, For Harold Lasswell: Some Reflections on Human Dignity, Entrapment, Informed Consent, and the Plea Bargain, Yule Law Journal 84 (1975): , at Some observers would like to press dignity torts even further. During the late 1990s and early 2000s a series of lawsuits against several major research institutions attempted to bring dignity torts into the research arena by arguing that the Nuremburg Code and the Declaration of Helsinki warrant a dignity tort when research subjects are inadequately informed about the protocol s objectives and risks. As ofaugust 2003, for instance, the website featured several cases arguing for such causes of action. Courts have not been receptive to importing international ethics codes into U.S. law. Just one court has indicated any willingness to regard the Nuremberg Code or the Declaration as US. law. The Maryland Court of Appeals, arguing that there is a special relationship between investigator and subject, acknowledgedthat although no United States court has ever awarded damages to an injured experimental subject, or punished an experimenter, on the basis of a violation ofthe Nuremberg Code, nevertheless the Code was intended for international application and has never been rejected in the US. Grimes v. Kennedy Krieger, 782 A.2d 807,834 (Md. 2001). Even here, the court s interest in the Code appears as dicta rather than black-letter law. Several other courts have cited the Nuremberg Code and Helsinki Accords, but as ideals, not as domestic law. See, e.g., In re Cincinnati Radiation Litigation, 874 ESupp. 796, (S.D. Ohio 1995). See also Heinrich ex rel. Heinrich v. Sweet, 62 F.Supp.2d 282, 321 (D. Mass. 1999) (Heinrich III); Whitlock v. Duke University, 637 ESupp. 1463, (M.D.N.C. 1986), a d, 829 F.2d 1340 (4th Cir. 1987); U. S. v. Stanley, 107 S.Ct. 3054,3065 (OConner, J. dissenting), 3066 (Brennan, J. dissenting) (1987); White v. Paulsen, 997 F.Supp. 1380, (E.D. Wash. 1998); Hooverv. West Virginia Dept of Health and Human Services, 984 ESupp. 978,978 (S.D. W. Va. 1997), a d, 129 F.3d 1259 (11th Cir. 1997) Heinrich v. Sweet, 308 E3d 48,60-61 (1st Cir. 2002) (Heinrich vl) Lugenbuhl v. Dowling, 701 So.2d 447, (La. 1997) In Dim 0. Tampa General Hospital, such reasoning led to a high-dollar settlement in a case where no physical injury was ever claimed. Plaintiffs argument was that sophisticated consent forms were tantamount to inadequate research disclosures for pregnant women whose socioeconomic and cultural status impeded their comprehending the information they were given. Plaintiffs were poor, uneducated, mostly Spanish-speaking women who said that they did not understand the three-page, IRB-approved consent form. In addition to conceding there was no injury, the plaintiffs also agreed that they had signed the consent form. When the case was certified as a class action, defendants determined they could not afford to defend the suit. A settlement of $3.8 million closed the case. Diaz v. Tampa General Hospital, 2000 WL (M.D. Fla. 2000). See also Research Roundtable Report on Diaz v. Tampa General, at <www.researchroundtabkcom> Krause, supra note 83, at Canterburyv. Spence, 464 F.2d 772,791 (D.C. 1972). See also Lugenbuhl v. Dowling, 701 So9d 447,454 (La. 1997); Sard v. Hardy, 379 A.2d 1014, 1025 (Md. App. 1977); Guebard v. Jabay, 452 N.E.2d 751,757 (Ill. App. 2 Dist. 1983); Howard v. University of Medicine, 800 A.2d 73,79,84 (N.J. 2002); Krause, supra note 83 at Woolleyv. Henderson 418 A.2d 1123,1132 (Me. 1980); Sardv. Hardy, 379 A.2d at 1025; Canterbury v. Spence, 464 F.2d 772, (D.C. 1972); Arena v. Gingrich, 748 P.2d 547,549 (Or. 1988) Schreiber v. Physicians Ins. Co., 588 N.W.2d 26,34 (Wis. 1999) See Krause, supra note 83, at 319; Weisbard, supra note 112: at Katz, supra note 38, at Zalazarv. Vercimak, 633 N.E.2d 1223 (Ill. App. 3 Dist. 1993) Zalazar v. Vercimak, 633 N.E.2d Sehreiber v. Physicians Ins. Co., 588 N.W.2d 26 (Wis. 1999) Id. at This basic right to know and decide is the reason for the full-disclosure rule...athough it might be said this approach places a physician at the mercy of a patient s hindsight, a careful practitioner can always protect himselfby insuringthat he has adequately informed each patient he treats. Scott v. Bradford, 606 P.2d 554,559 (Okla. 1980). See also Zalazar v. Vercimak, 633 N.E.2d 1223,1227 (Ill. App. 3 Dist. 1993); Noah, supra note 3, at THE JOURNAL OF LAW, MEDICINE & ETHICS

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