Two-Dimensional Doctrine and Three-Dimensional Law: A Response to Professor Weinstein

Article excerpt

Professor Weinstein examines how the IRB laws would fare under Supreme Court doctrine, and whereas it is my view that these laws should be considered unconstitutional, he reaches largely the opposite conclusion. His article therefore offers a valuable opportunity for further exploration of the constitutional questions, and although there is not sufficient space here to discuss all of his analysis, it seems important at least to draw attention to the major points on which we take different perspectives.


It is probably best to begin by clarifying my basic constitutional arguments. I had obviously hoped to make my positions clear, but I may perhaps have failed in this regard. Certainly, upon reading Professor Weinstein' s article, I cannot help thinking that one can never be clear enough. Therefore, even if at the risk of repetition, it seems necessary to draw attention to some of my positions.

First, rather than concern conduct, my argument is that the IRB laws "target and even specify speech and the press as the object of their licensing."1 In Professor Weinstein' s view, I take the position that the IRB laws are regulations of conduct, and on this basis he answers that such regulations are unlikely to be held unconstitutional.2 It may be that my argument should centrally concern conduct, but this is not my focus. On the contrary, my argument emphasizes that the IRB laws "candidly require IRBs to license the verbal core of speech and the press."3

Second, far from relying exclusively on spending conditions, my argument is that the IRB laws have the full obligation of law. Professor Weinstein is under a different impression and says I take the view that the IRB laws are unconstitutional "even though" they "are not directly imposed on research institutions by force of law but rather are adopted ... as a condition on receiving federal research funds."4 In fact, although I discuss such conditions and argue that they should be considered unconstitutional, my argument concludes that the federal government now primarily relies on state negligence law to give force to the IRB laws. In particular, the government used its conditions to establish IRBs as the standard of care for conducting research, and having thus successfully "elevated IRBs as the standard method of avoiding research injuries, it could rely on state tort law to induce research institutions to use IRBs."5

Third, my argument rests on the concept of licensing rather than the notion of prior restraint. Professor Weinstein assumes it is my view that the IRB laws are unconstitutional as prior restraints. He thus says that my argument is "[specifically . . . that these regulations constitute a contentbased prior restraint."6 This is the sort of analysis, however, that I specifically reject. Instead, my argument is that notwithstanding Supreme Court doctrine on prior restraint, the core of the freedom of speech and the press remains a freedom from licensing. On this basis, the IRB laws should be considered unconstitutional because they "set up a system of licensing" and "target and even specify speech and the press as the object of their licensing."7

In short, rather than rest on conduct, conditions, and prior restraint, my argument actually ends up focusing on verbal language, the direct obligation of law, and licensing.


More significantly, the IRB laws themselves are a matter on which there are different perspectives. It is especially important to examine these differences, for an analysis of the IRB laws must rest on the reality of these laws.

It is possible to take the view that the IRB laws concern conduct rather than speech. Certainly, the IRB laws focus on "research," and Professor Weinstein therefore assumes that the laws specify a sort of conduct. The Common Rule, however, defines research in terms of verbal language - as a "systematic investigation" in pursuit of "generalizable knowledge. …