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 NATIONAL HEALTH REFORM AND AMERICA’S UNINSURED FALL 200 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.