When Stephen Rosenfeld and Patricia Seymour founded the not-for-profit North Star Review Board, they’d become disillusioned with the scientific oversight system in America. IRBs, or institutional review boards, are supposed to have one priority top of mind: the rights and welfare of human research participants. But after decades as research ethicists, Rosenfeld and Seymour thought the industry had lost its way.
The problem, they said, isn’t just theoretical. Over the last couple of decades, IRB scandals have cast a spotlight on a fundamental problem in the system, experts said. In one such example, the Government Accountability Office in 2009 tested whether a group of for-profit IRBs could successfully detect a bogus unethical research protocol and reject it. One of the three companies tested, Coast IRB in Colorado, approved the fictitious application, even though the fake device had specifications and matched several examples of “significant risk” per FDA guidance. The sting operation revealed what the GAO called a vulnerability to “unethical manipulation” in the IRB system.
