The Independent Evolution of Informed Consent to Research

Abstract

Despite apparent similarities in the issues raised, informed consent in the research setting has evolved quite separately from informed consent to treatment. Consent to treatment is largely a creature of case law, with some subsequent statutory modification. Consent to research has been shaped by professional codes, statutes, and administrative regulations, with the courts playing a less important role. Systematic medical research, of course, is a newer phenomenon than medical treatment. The eighteenth century saw some of the first efforts to demonstrate the etiology of diseases. One was Lind’s controlled study of the effects of citrus juices in preventing scurvy (1). Pierre Louis’s classic study, in the 1820s, of the efficacy of bloodletting as a treatment for pneumonia demonstrated the potential of clinical investigation, but his medical colleagues were slow to follow his lead (2). By the turn of the century, the pace of experimentation with human subjects was quickening. The etiologies of beriberi and pellagra, for example, were discovered using human volunteers. In the early years of systematic medical investigation, only sporadic attention was paid to the circumstances under which research should be carried out, including the issue of consent. There are a few statements from leading physicians of the time, such as Paul Ehrlich and William Osier, endorsing the disclosure of information about the risks and benefits of experimental treatment. After a public scandal in Prussia in the 1890s, involving experimentation on unsuspecting patients who were inoculated with the spirochete that causes syphilis, the Prussian government required consent for any further research with human subjects (3). Shortly thereafter, Walter Reed, conducting his famous experiments in Cuba on yellow fever, developed a contract—very much like the modern consent form— for his volunteers to sign, which included a discussion of the risks they would be running (3). Public concern in Germany culminated in the 1931 promulgation of guidelines that required clear explanations of innovative or experimental treatments (4). Interestingly, this pre-war German code of ethics, which addressed human experimentation, was, in some ways, more extensive in its protections and principles than either the post-war Nuremberg Code or Helsinki Declaration (5).