This focus on collaboration will more effectively facilitate the implementation of ethical research. For research to be truly ethical, it must be tailored to the individual setting; a one-size-fits-all approach is inadequate. Every research setting and population presents unique challenges and concerns. Ethically appropriate subject protections in one institution may be grossly inadequate in another. Only through close cooperation and communication with all relevant parties, in every implicated setting, can researchers ensure that they are creating ethical conditions that are favorable for respect and unfavorable for exploitation in any research context.

THE 1976 COMMISSION’S ETHICAL FRAMEWORK

Historical Context

The commission’s deliberations took place against a background that included the Nazi experiments with concentration camp prisoners followed by the adoption of a stringent standard of voluntary consent in the Nuremburg Code. Many interpreted the code’s statement that potential subjects “be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion” (U.S. GPO, 1953) as precluding participation by prisoners.

This thinking was reinforced by publicity about the realities of research in prisons. The late 1960s and early 1970s saw a series of exposés documenting abuses in connection with nontherapeutic research in U.S. prisons (Mitford, 1973a,b; Rugaber, 1969). Many of those who were most vocal about the plight of prisoners (i.e., journalists and prisoner advocacy and civil liberties groups) saw research with prisoners largely under the twin headings of coercion and exploitation (Mitford, 1973a,b; Rugaber, 1969). For the most part, these groups pushed for restriction rather than reform of the prison research enterprise.

Although the commission did not recommend a ban on all research with prisoners, their work and the subsequent scholarship and regulation have been described as tending toward that result: “The result of these regulations has been, as was their goal, the virtual elimination of biomedical research activity in prisons and jails” (Dubler and Sidel, 1989). According to one informed estimate, in the late 1990s only about 15 percent of institutions that engaged in clinical research in the United States included prisoners in their research protocols (Hoffman, 2000). In 1997, New York State had the largest estimated number of HIV-infected prisoners of any prison system (9,456), but only 8 (less than .001 percent) were enrolled in clinical trials (Lazzarini and Altice, 2000).



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