AFA Releases Guidance Statement on Institutional Review Boards
Statement calls mission creep of IRBs an “ongoing threat to academic freedom”
Princeton, NJ – The Academic Freedom Alliance today released a new guidance statement urging universities and colleges, and their Institutional Review Boards (IRBs), to adopt a new set of principles to guide and improve deliberation and review of research protocols for research on human subjects. The statement follows a steady drift of IRBs away from their original purpose of assessing risk to human subjects and toward a much broader effort to supervise the intellectual content and political implications of research.
“The IRB review process is too often unnecessarily obstructive,” writes the AFA in its statement, “with boards delving into areas beyond their remit and making demands that impede, distort, and even block research altogether. In doing so, IRBs disregard the research subjects’ autonomy and investigators’ needs. As tribunals without significant accountability, they are vulnerable to bureaucratic overreach and ideological capture. It is time to rein in IRB review to protect academic freedom.”
The statement endorses the Mudd Code, which proposes reforms in three areas:
- Transparency – including open deliberations, named reviewers, and timely decisions
- Justification of risk evaluation – tying all requirements explicitly to the principles of the Belmont Report, consistent with the original ideal of IRBs
- Limits on risk reduction – defining the minimal-risk threshold and rejecting the logic of total-risk elimination
The statement also proposes adding a science advocate to IRBs to represent the value of research and academic freedom. Together, these reforms would help restore IRBs to a narrower, risk-balancing role rooted in the Belmont principles, while protecting academic freedom and subject autonomy.
The statement concludes: “Respect for the research mission, embodied in the concept of academic freedom, must always be a priority as the academic community works to return IRB review to its necessary and appropriate mission.”
The drafting committee for this statement consisted of the following participants:
- Evan Morris, Chair, Yale University*
- Luana Maroja, Williams College*
- Julia Schaletzky, University of California, Berkeley*
- Sally Satel, Yale University School of Medicine*
- Lee Jussim, Rutgers University *
- Peggy Mason, University of Chicago*
- Anna Krylov, University of Southern California*
- Janet Halley, Harvard University*
*Affiliations are for identification purposes only
Evan Morris of Yale University, who chaired the drafting committee, said the following: “Institutional Review Boards (IRBs) play a necessary and vital role in the evaluation and balancing of risk to human subjects in biomedical research. Unfortunately, 50 years after the Belmont Report which set out the principles of ethical research, the roles and processes of IRBs have expanded, beyond their mission. This often serves to delay, frustrate or cancel meritorious biomedical research and scientists. The Mudd Code offers a countervailing set of principles to help IRB members adhere to the original principles of the Belmont Report while avoiding corrosive mission creep and over-regulation.”
Anna Krylov of USC, who also served on the drafting committee, offered the following quote: “The greatest threat to U.S. science today is not a lack of talent or ideas, but the bureaucratic quagmire that increasingly surrounds research. Institutional Review Boards, originally intended as safeguards, have in many cases become contributors to this problem—at times functioning more as censors than as protectors. An effort to curb bureaucratic overreach and restore common sense to the system is both timely and necessary.”
The Academic Freedom Alliance is a diverse alliance of college and university faculty members who are dedicated to upholding the principles of academic freedom and professorial free speech. These principles are central to the mission of our institutions of higher education for the pursuit of truth and knowledge. The AFA is committed to defending universal principles of academic freedom and will come to the assistance of professors regardless of their individual views. As always, the AFA is not concerned with the substance or merits of a professor’s ideas but with the principle that universities should be places that tolerate controversial ideas and allow free inquiry and debate, not public opinion or political pressure, to separate error from truth.