Institutional Review Boards and the Constitution

By Weinstein, James | Northwestern University Law Review, January 1, 2007 | Go to article overview

Institutional Review Boards and the Constitution


Weinstein, James, Northwestern University Law Review


INTRODUCTION

Several participants in this symposium make a strong case that federal Institutional Review Board ("IRB") regulations stifle valuable scientific research.1 But even if IRB regulations are perfectly dreadful social policy, it does not follow that they are unconstitutional. Both in this symposium and in a previous article,2 however, Philip Hamburger makes a sustained argument that IRB regulations are indeed unconstitutional. Specifically, he argues that these regulations constitute a content-based prior restraint on speech in violation of the First Amendment. In Professor Hamburger's view, these constitutional problems exist even though federal IRB regulations are not directly imposed on research institutions by force of law but rather are adopted by these institutions as a condition on receiving federal research funds.

Contrary to Professor Hamburger, I do not believe that IRB regulations would constitute a facially unconstitutional infringement of free speech even if directly imposed on research institutions. That these regulations are adopted by research institutions as a condition of receipt of federal funding makes any facial attack on their constitutionality even less tenable. But this does not mean that IRBs are free of constitutional problems. Indeed, although IRB regulations are constitutional on their face and in most of their applications, certain applications pose difficult First Amendment questions. In addition, various applications of these regulations might implicate the constitutional right of thought and inquiry.

An obvious impediment to any claim that IRB regulations violate the right of free speech is that much scientific research involves primarily conduct and very little expression. This is particularly true of biomédical research, which involves such activities as organ transplants, blood draws, drug studies, and brain scans. Other types of research do, however, contain significant communicative elements. Social science research in particular typically involves the use of surveys, questionnaires or conversations to elicit information from subjects, as well as written and oral instructions to subjects as part of experiments. Because of this marked difference, I shall deal with biomédical and social science research separately.3

As Part I of the Article demonstrates, an insurmountable obstacle to any First Amendment challenge to the application of IRB regulations to ordinary biomédical research is that this type of research is not "speech" within the meaning of the First Amendment. As such, this activity would not be entitled to any First Amendment protection unless it were deemed either "expressive conduct" or an "essential precondition" to speech. Biomedical research does not qualify as expressive conduct because, unlike flag or draft card burning as a form of political protest, this activity does not convey a "particularized message" to the public. Nor, despite the fact that biomédical research often leads to the publication of useful information, would it qualify for First Amendment protection as conduct that is a "necessary precondition" of speech.4 The few cases in which the Court has extended First Amendment protection on this ground all involve conduct necessary to speech intimately connected with democratic self-governance, such as the expenditure of money for political speech or press access to criminal trials. Being neither particularly expressive nor intimately connected to democratic self-governance, biomédical research would therefore be classified as "nonexpressive conduct" entitled to no First Amendment protection. As such, the prohibition against prior restraints on speech is simply inapplicable to this conduct, as is the rule against content-based speech regulation.

Part II of this Article explores the more difficult First Amendment issues arising from IRB regulation of social science research. Unlike typical biomedicai research, social science research almost always involves significant communicative elements that would be classified as "speech" under the First Amendment. …

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