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101 Nw. U. L. Rev. 405 (2007)
Getting Permission

handle is hein.journals/illlr101 and id is 413 raw text is: Copyright 2007 by Northwestern University School of Law Printed in U.S.A. Northwestern University Law Review Vol. 101, No. 2 GETTING PERMISSION Philip Hamburger* INTRODUCTION Institutional Review Boards (IRBs) are the instruments of a system of licensing-a system under which scholars, students, and other research- ers must get permission to do research on human subjects. Although the system was established as a means of regulating research, it regulates re- search by licensing speech and the press. It is, in fact, so sweeping a sys- tem 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 li- censing 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 Surround- ing it are other laws, federal and state, that give the licensing the obligation Maurice and Hilda Friedman Professor of Law, Columbia Law School. For their comments and advice, I am grateful to many learned colleagues, including: Tom Baker, Caroline Bledsoe, Mike Dorf, Harold Edgar, Suzanne Goldberg, David Hyman, Jim Lindgren, Jon Merz, and Henry Monaghan; the participants at the Northwestern University Law Review Conference; Paul Applebaum and the other par- ticipants at the Seminar Series of the Division of Psychiatry, Law and Ethics, Department of Psychiatry, Columbia University; and, not least, David Crowley, Caleb Edwards, Charleen Hsuan, Aaron Leider- man, Jonathan Shapiro, Leanne Wilson, and all of the other participants in the Legal Scholarship Work- shop at Columbia Law School. I JOHN MILTON, AREOPAGITICA: A SPEECH OF MR. JOHN MILTON FOR THE LIBERTY OF UNLICENSED PRINTING, TO THE PARLIAMENT OF ENGLAND (1644). Galileo sought a license to print for his Dialogue in 1630 and was punished by the Inquisition in 1633-in part because he obtained the li- cense without explaining to the licenser that he had earlier been warned not to advocate his ideas. For details, see infra note 190. 2 See infra text accompanying note 22. 3 The Common Rule has been adopted by seventeen federal agencies and departments, and for the sake of convenience, this article cites the Health and Human Services promulgation of the Common Rule at 45 C.F.R. pt. 46 (2005).

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