other, from clinical innovation. ConNATIONAL HEALTH REFORM AND AMERICA’S UNINSURED * FALL 200 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 475 INDEPENDENT a drug that is personally less effective for him than the alternative^."^ In research, subjects' individual needs The bare fact that a physician like to draw genera' and preferences &I only enter in either of conclusions from his personal observations does not mean that variation and preference, or via removing he has undertaken research. constitute constraint;"ll that is, def- and discipline of the activity: two ways: via whatever flexibility a protocol may have built in to accommodate personal that person from the study altogether. In this sense, the interests of the individual The crucial factor is the design erence to individuals is a limiting factor, not the goal of the activity?2 This does not mean, of course, that a reactivity to test an hypothesis, draw conclusions, and thereby search project can not provide red bene- develop generalizable knowledge. 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 relafits 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