Science Is the Thing. Why and How to Restore Balance Between U.S. Institutional Review Boards and Investigators
1 Radiology and Biomedical Imaging, Yale University, New Haven, CT 06520, USA
2 Psychology, Rutgers University, Livingston Campus, Piscataway, NJ 08854, USA;
3 Neurobiology, University of Chicago, Chicago, IL 60637, USA;
4 American Enterprise Institute, Washington, DC 20036, USA;
* Corresponding author:
* Author to whom correspondence should be addressed.
(this article belongs to the Special Issue Special Issue Censorship in the Sciences)
Received: 16 Mar 2025 / Accepted: 18 Sep 2025 / Published: 27 Oct 2025
Abstract
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.
Keywords: Mudd Code; Belmont Report; respect for persons; IRB; bureaucratic overreach; overregulation; regulatory burden; human subjects research; self-experimentation
OPEN ACCESS
This is an open access article distributed under the Creative Commons Attribution
License which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly cited. (CC BY 4.0).
CITE
Morris, E.D.; Jussim, L.; Mason, P.; Satel, S. Science Is the Thing. Why and How to Restore Balance Between U.S. Institutional Review Boards and Investigators. Controversial_Ideas 2025, 5, 2.
Morris ED, Jussim L, Mason P, Satel S. Science Is the Thing. Why and How to Restore Balance Between U.S. Institutional Review Boards and Investigators. Journal of Controversial Ideas. 2025; 5(2):2.
Morris, Evan D.; Jussim, Lee; Mason, Peggy; Satel, Sally. 2025. "Science Is the Thing. Why and How to Restore Balance Between U.S. Institutional Review Boards and Investigators." Controversial_Ideas 5, no. 2: 2.
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