IRBs have a problem. Can North Star’s nonprofit model save it?
As institutional review boards face pressure from companies and ethicists, North Star Review Board offers a nonprofit model as more independent.
Stephen Rosenfeld and Patricia Seymour, once research ethicists, established the nonprofit North Star Review Board in response to their dissatisfaction with the existing institutional review board (IRB) system in the United States. The core issue they identified was a shift away from the IRB's primary objective: safeguarding the rights and welfare of human research participants.
Over the past two decades, a series of IRB scandals have exposed a significant flaw in the system, according to experts. The Government Accountability Office's (GAO) investigation in 2009 demonstrated the vulnerability within the IRB system. The test involved a for-profit IRB company, Coast IRB in Colorado, which approved a fraudulent research protocol, despite it matching numerous instances of "significant risk" as per FDA guidance.
This revelation highlighted the potential for "unethical manipulation" within the IRB system, raising serious concerns about the efficiency and integrity of the oversight process.
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