Document Type

Article

Publication Date

2007

Abstract

Institutional Review Boards ("IRBs") are the instruments of a system of licensing-a system under which scholars, students, and other researchers must get permission to do research on human subjects. Although the system was established as a means of regulating research, it regulates research by licensing speech and the press. It is, in fact, so sweeping a system of licensing speech and the press that it is reminiscent of the seventeenth century, when Galileo Galilei had to submit to licensing and John Milton protested against it.' Accordingly, it is necessary to examine the constitutionality of IRB licensing and, more generally, to explore the dangers of licensing speech and the press. The Supreme Court has come to understand such licensing merely as a sort of prior restraint.2 Licensing, however, is a distinctly dangerous type of prior restraint, for it requires one to get permission. This inquiry focuses on the various laws that generally impose IRB licensing on human subjects research-a range of statutes, regulations, and common law doctrines here called "the IRB laws." At their center is the Common Rule, which sets out a federal model for the licensing.3 Surrounding it are other laws, federal and state, that give the licensing the obligation of law.4 Under this system of laws, universities and other research institutions establish IRBs to review human subjects research, and consequently most teachers and students must get permission from an IRB before they conduct any such research. There are other uses of IRBs-notably, under FDA regulations-but it is the more general use of IRBs to license human subjects research under the IRB laws that requires immediate attention.5

Comments

Institutional Review Boards ("IRBs") are the instruments of a system of licensing-a system under which scholars, students, and other researchers must get permission to do research on human subjects. Although the system was established as a means of regulating research, it regulates research by licensing speech and the press. It is, in fact, so sweeping a system of licensing speech and the press that it is reminiscent of the seventeenth century, when Galileo Galilei had to submit to licensing and John Milton protested against it.' Accordingly, it is necessary to examine the constitutionality of IRB licensing and, more generally, to explore the dangers of licensing speech and the press. The Supreme Court has come to understand such licensing merely as a sort of prior restraint.2 Licensing, however, is a distinctly dangerous type of prior restraint, for it requires one to get permission.

This inquiry focuses on the various laws that generally impose IRB licensing on human subjects research-a range of statutes, regulations, and common law doctrines here called "the IRB laws." At their center is the Common Rule, which sets out a federal model for the licensing.3 Surrounding it are other laws, federal and state, that give the licensing the obligation of law.4 Under this system of laws, universities and other research institutions establish IRBs to review human subjects research, and consequently most teachers and students must get permission from an IRB before they conduct any such research. There are other uses of IRBs-notably, under FDA regulations-but it is the more general use of IRBs to license human subjects research under the IRB laws that requires immediate attention.5

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