title: Empirical research to evaluate ethics committees' burdensome and perhaps unproductive policies and practices: a proposal.
abstract: THE U.S. SYSTEM FOR THE PROTECTION of human research subjects, particularly its ethics committee or Institutional Review Board (IRB) component, is excessively burdened. Many commentators, myself included, are concerned that, as a consequence of these excessive burdens, the IRB is losing its effectiveness in safeguarding the rights and welfare of human subjects. I believe that IRBs devote too much time doing work that simply does not need to be done. Several routine practices of IRBs are highly time consuming and, in my opinion, not sufficiently productive to warrant their continuation in their present form. Empirical research can and should be done to evaluate the consequences of these practices. If they are found to be insufficiently cost-effective, they should be modified or abandoned. This would result in reducing the burdens on IRBs, freeing up reviewers' time and energy to concentrate on more important and productive pursuits. I suggest we begin by evaluating two routine practices: (1) The practice of conducting all continuing reviews of ongoing research at convened meetings of the IRB. (2) The practice of referring all adverse events to the IRB for its review.
authors.affiliation: Yale University.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Levine