Document Type

Article

Publication Title

Northwestern University Law Review

Abstract

Rather than struggle mightily against the odds, I prefer to offer a different perspective to this problem that pays little or no attention to the present structure of constitutional law. Accordingly, my mission is to raise this question of first principle. If we had a sensible small government state, what would be the proper way to fund and control various forms of research both in biology and in the social sciences? I make no pretense that the answers to this question will resonate with either current law or practices. And I undertake this inquiry in order to lay bare what are, I think, the major sources of uneasiness with the entire IRB enterprise, as it has lurched out of control. In order to do this we shall take nothing for granted at the outset, including the power of the federal government or the states to regulate various kinds of research. Some people will reject my recommendations for reform, but I hope that they will nonetheless join the ranks of the many who think that the present political equilibrium has shifted too far in the direction of massive federal regulation. Accordingly, Part I briefly explains why the control of force and fraud is a legitimate government function. Part II then looks at the remedial structure, both public and private, that should be used to deal with the control of fraud and misinformation, which lies at the core of the IRB mission. Part III then examines how the Belmont Report, which contains the canonical justifications for IRBs, makes a series of key conceptual errors that expand the government's role in providing information for private choices into an arrogation of power that removes the possibility of private choice. Part IV then proposes a brief alternative system that seeks to remove from the IRB the power to block any biomedical or behavioral research, but allows it the right to comment publicly on any and all proposals for research that it can review before individual people choose to sign up. The government should have the right to post messages on a public bulletin board, not to shut down all programs that do not meet its most exacting standards.

First Page

735

Volume

101

Publication Date

2007

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