Litigation in clinical research: malpractice doctrines versus research realities.

uman clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, H 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 particular 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.