Lesser Harms: The Morality of Risk in Medical Research (review)
Buy Issue for $25 at JHUP- Lesser Harms: The Morality of Risk in Medical Research
In Lesser Harms, Sydney Halpern analyzes the history of social control of human experimentation. Three eras are examined: when the scientific community alone exerted control; when organizational sponsors regulated the research; and when the federal government regulated human experiments. Halpern's evidence is drawn from vaccine tests for smallpox, rabies, influenza, measles, and polio, which have a long history that involved "especially stark discussions of hazards and benefits" (p. 10).
Restrictions of human experimentation beginning in the eighteenth century were based on the "moral traditions" (p. 2) of the scientific community. Scientists agreed that interventions must produce "lesser harms" (p. 4)—that is, less than the risks of the naturally occurring disease; the experiments must be "technically sound" (p. 5); animal experimentation must precede human experimentation; and experiments must be suspended if early findings showed high levels of risk. Halpern concedes that there have been "marked variations in the application of [End Page 830] moral traditions" (p. 7), owing to disagreements about interpretation of the evidence and the appropriate risk-benefit ratio. In addition, "research networks are informal groups, poorly equipped to impose coercive constraints on their members. . . . Their principal means of social control are granting and withholding esteem and ostracizing those who violate collective norms" (pp. 64–65).
The early twentieth century saw a transition to the "morality of method" (p. 36) by the scientific community. This new approach insisted on technical expertise in study design and procedures, and the use of controlled trials. Scientific leaders aborted the polio vaccine experiments in the 1930s because of dubious experimental techniques and interpretations of data.
Organizational research sponsors then became the arbiters of human testing of vaccines, using three strategies: risk avoidance (refusing to support experiments); risk containment (imposing controls on the researchers); and risk delegation (delegating control to the researchers). Examining polio and influenza vaccine research in the 1930s, Halpern found that commercial sponsors used risk delegation more often than sponsors such as the National Foundation for Infantile Paralysis. By mid-century, organizations that sponsored research, now including the federal government, routinely adopted risk-containment strategies. This new policy was due to the rationalization typical of large organizations and to agreement on methods, including legal strategies, that would obtain social legitimacy and avoid legal sanctions. Organizations used written consent forms, oversight by scientific panels, and (least often) insurance for injured subjects. The written consent forms were "largely ceremonial" (p. 110). Advisory panels became widespread; they provided direction and intervened in hazardous situations. Halpern states that these controls were sometimes used to justify the undertaking of "extremely dangerous nontherapeutic experiments" (p. 110).
The third period began in the 1960s when federal agencies undertook the regulation of human-subject research and later required the establishment of Institutional Review Boards to oversee the ethical conduct of research. The new rules greatly expanded the scope and importance of informed consent. Halpern contends, however, that these new institutional regulations have not superseded the need for the moral traditions of the scientific community: Official oversight has sometimes failed to utilize scientific expertise, with fatal consequences for subjects. Informed consent has been used to justify hazardous experiments. Corporate involvement in medical research has made researchers behave more like "isolated entrepreneurs than members of a scientific community" (p. 153). Halpern proposes a return to the free flow of scientific information that once characterized the scientific community.
Lesser Harms is constructed on an impressive framework and describes an important subject. However, the federal regulation era is insufficiently described, and material on individual topics is often dispersed throughout the book. Nevertheless, this is a valuable history of basic changes in the regulation of human experimentation.
