A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable-- though in practice often unattainable-goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.
Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies,1 though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses. Nowadays, sponsors run national television advertisements and host Internet sites,2 and they also may offer IMAGE FORMULA5
financial incentives to fanily for recruiting subjects from among their existing patients.3
Clinical trials have proliferated in recent years for a variety of reasons. In part, the total volume of biomedical research and development has increased substantially, resulting in a greater number and complexity of new investigational products; in part, federal regulatory requirements for proof of safety and effectiveness have expanded;4 and, in part, patients have become more interested in participating as research subjects, either because their conditions have not responded to existing treatments or because they lack the insurance coverage and resources to afford standard treatments.5 In 1997, reacting to these developments, Congress instructed the National Institutes of Health (NIH) to maintain an Internet site designed for patients seeking ongoing clinical trials in which to enroll.6
Do patients who decide to enroll in clinical trials really understand the nature of these experiments? Federal regulatory agencies have created elaborate protections for human subjects, and a requirement to secure informed consent occupies a central place in these systems. In contrast, outside of the context of clinical trials, federal regulatory agencies have done little to insist that physicians secure informed consent from their patients, instead leaving that task to state tort law. Over the last several decades, medical malpractice doctrine has expanded the disclosure obligations of physicians, but the courts have struggled when asked to apply these rules in the context of experimental procedures. This should come as no surprise, however, because no distinct line separates standard and experimental treatment.
To a greater or lesser extent, all medical interventions have an experimental quality to them. Physicians try things out on their patients all of the time. In many instances, we hope, they do so based on well-grounded confidence in the likely utility of a particular therapy, though even then the variability in patient response may disappoint our expectations. In far too many instances, unfortunately, physicians select interventions that remain poorly understood. Even for those therapeutic choices subject to federal licensing requirements, particularly IMAGE FORMULA8
pharmaceuticals, product approval does not define the point at which an investigational intervention passes the threshold into standard therapy. Instead, the research phase continues after licensure, both in the sense that more safety data accumulates and insofar as physicians may improvise when using a product in ways not originally contemplated. Conversely, an investigational product may become the standard of care even before federal regulators bestow their blessing on a particular use. …