TY  - EJOU
AU  - Morris, M. Evan D.
AU  - Jussim, J. Lee
AU  - Mason, M. Peggy
AU  - Satel, S. Sally
TI  - Science Is the Thing. Why and How to Restore Balance Between U.S. Institutional Review Boards and Investigators
T2  - Journal of Controversial Ideas

PY  - 2025
VL  - 5
IS  - 2
SN  - 2694-5991

AB  - 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.
KW  - Mudd Code
KW  - Belmont Report
KW  - respect for persons
KW  - IRB
KW  - bureaucratic overreach
KW  - overregulation
KW  - regulatory burden
KW  - human subjects research
KW  - self-experimentation
DO  - 10.63466/jci05020002