Development of the Hybrid Rule and the Concept of Justice: The Selection of Subjects in Biomedical Research

As biomedical research with volunteers was expanded in the United States, the rule of subject selection, constituting scientific and ethical criteria, was generated in 1981 to resolve selection bias in research. Few historical studies, however, have investigated the role of this new hybrid rule in institutional review systems. This paper describes how bioethics commissions and federal agencies have created the subject selection rule based on the concept of justice. I argue that the standardization of this rule as temporal measures, linked with risk-benefit assessment, has reformed the review mechanism, specifically investigators' modification of research plans, thereby developing justice as balancing.

1. Introduction

In 1991, the federal policy for the protection of human subjects (codified as 45 CFR 46), namely the Common Rule, was issued by the Office of Science and Technology Policy (OSTP) on behalf of a number of federal departments and agencies in the United States. The Common Rule, consisting of a set of principles and rules, is the most prevalent standard for federally-funded research with human subjects, evaluated by institutional review boards (IRBs). One component of the Common Rule explicates the rule for the selection of subjects. This rule holds that the "[s]election of subjects is equitable," and that "[i]n making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted" (OSTP et al. 1991, p. 28016).

The rule of subject selection constitutes both scientific and ethical criteria. Whereas "subject selection requires that the scientific goals of the study … be the primary basis for determining the groups and individuals that will be recruited and enrolled" (Emanuel et al. 2000, p. 2704), the selection of subjects also highlights ethical safeguards to protect the rights and welfare of human subjects, especially "vulnerable populations" (OSTP et al. 1991, p. 28016). This hybrid rule of subject selection has involved an "important innovation" of the federal regulations (Veatch 1981, p. 10). Specifically, the previous federal rule of rights and welfare, implemented from the mid-1960s to the 1970s, was replaced by the rule of the selection of subjects issued in the federal regulations of 1981. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) of 1974–1978 also formulated the rule of subject selection as the application of the principle of justice that includes the concept of equity or additional safeguards for vulnerable subjects. As several studies have remarked (e.g., Brody 1998), the concept of justice formed by the rule of subject selection was transformed from the mid-1980s to the 1990s, moving away from the concept of justice as protection into justice as balancing between risks and benefits.

Despite its significance, however, no detailed historical studies have delved into the process by which the rule of subject selection was created to resolve the selection bias in biomedical research with volunteers emerged especially from the middle 1960 to the early 1970s. More importantly, few descriptive studies have examined specifically how the stabilization of subject selection rule has changed the review mechanism that has adopted the concept of justice in research. What exactly is the rule of subject selection? How has the rule of subject selection been built into the institutional review mechanism? How has the rule of subject selection been connected to the concept of justice? I argue that the standardization of the subject selection rule as one temporal standard has advanced the review system, urging biomedical scientists to modify the scientific design of biomedical research, and that this new review mechanism has facilitated shifting the protective conception of justice, protective justice, into the balancing conception of justice, that is, distributive justice as a distribution of burdens and benefits. This paper describes how bioethics commissions and federal agencies have generated the rule of subject selection, in accordance with the concept of justice.

Before this paper delineates the historical grounds, it recapitulates how my argument is relevant to science and technology studies (STS). This entry also specifies key concepts of my analysis. Scholarship in STS has traditionally...