I have posted the paper I prepared for the May 2012 Petrie-Flom conference as "What is this Thing Called Research? (May 7, 2012), http://ssrn.com/abstract=2182297.
A shorter version will appear in a book to be published by the MIT Press, tentatively entitled The Future of Human Subjects Research Regulation.
Here is the abstract:
Since the 1950s, policymakers and researchers in the United States and abroad have labored to distinguish those activities that require some level of prior approval from other forms of human interaction and information exchange. In 1978, Albert Jonsen—a member of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research—expressed this problem well, when he said of a draft of the Belmont Report that “There is nothing in here that tells us why we are about to make a great big step which we have made from the beginning. Namely, why ought the thing that we are calling research be subject to what we call review?” Nearly half a century since the first federal requirements for IRB review, that question remains unanswered.
The ANPRM makes only a gesture at this crucial problem, asking, in Question 25, if there are "certain fields of study whose usual methods of inquiry were not intended to or should not be covered by the Common Rule . . . because they do not create generalizable knowledge and may be more appropriately covered by ethical codes that differ from the ethical principles embodied in the Common Rule.” But the generalizability of knowledge is only one of several criteria that have been advanced to distinguish research that should and should not be covered by regulations, and—I would argue—it is the least helpful. This paper seeks to explore more widely some of the efforts that have been made to distinguish activities that should be vetted by one or more reviewers prior to their initiation from those that should not. As we reconsider the regulatory system in the wake of the ANPRM, we should ask why we think some activities need review and craft definitions that include those and nothing more.