Institutional review boards, or IRBs, are oversight bodies tasked with protecting the rights and welfare of human research participants before any study can proceed. However, ethicists and researchers increasingly argue the system has become compromised by structural conflicts of interest, particularly as commercial entities have entered the IRB marketplace alongside traditional academic boards.
The current IRB framework traces back to the mid-20th century, when the federal government sought to shift liability for research misconduct away from itself and toward local institutions. This design choice, made following the revelation of the Tuskegee syphilis study and formalized in the National Research Act of 1974, created inherent conflicts of interest: universities conducting research also oversee that research, and for-profit IRBs are paid by the companies and institutions they review. Critics point to past scandals, including a 2009 Government Accountability Office test showing a for-profit IRB approved a fictitious unethical protocol, as evidence the system fails to adequately protect participants.
Experts argue modern pressures have worsened the problem. Research institutions face financial instability and rely on grants to operate, while pharmaceutical companies need to bring drugs to market quickly. This creates implicit pressure on IRBs to approve research rapidly rather than apply rigorous ethical scrutiny. Additionally, emerging research harms related to data privacy and information exploitation fall outside current regulatory frameworks, leaving gaps where ethically questionable but legally compliant research can proceed.
Stephen Rosenfeld and Patricia Seymour, both former commercial IRB employees, founded North Star Review Board as a nonprofit alternative. They argue that removing profit motive and investor returns allows boards to prioritize ethical review over speed and compliance minimums. However, critics note that even as a nonprofit, North Star still competes in the IRB marketplace and collects fees, potentially exposing it to similar systemic pressures.
Experts broadly agree the research oversight system requires fundamental reform, though regulatory changes face political obstacles. Until then, Rosenfeld hopes nonprofit models like North Star can create space for more ethically rigorous human subjects protection by ensuring research participants—who currently have no voice in a market-based system—become the primary stakeholder.
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