Science Is the Thing. Why and How to Restore Balance Between U.S. Institutional Review Boards and Investigators

In the United States, the Institutional Review Board (IRB) derives its power from the 1978 Belmont Report and the (Revised) Common Rule, effective in 2019, that propagates its authority to multiple federal agencies including NIH. The IRB serves as the local oversight committee protecting human subjects in social science and biomedical research. But how much protection is enough? And at what cost? We review several historical and modern cases as a means of illustrating the evolution of the IRB and its invasiveness. The cases correspond loosely to distinct eras in history that have been termed by Moreno, “Weak Protectionism,” “Moderate Protectionism,” and “Strong Protectionism.” We believe we have now descended into an era of “Hyper-Protectionism” in which the costs to science far outweigh the benefits to protection of human subjects. In response, we propose a set of guiding principles, the “Mudd Code,” aimed at restoring the balance between oversight and research efficiency and productivity.