Cost Is No Object
Cost Is No Object
High costs are built into IRB regulation of research. Prior licensing of each study requires searching mountains of innocuous studies to find molehills of baneful ones. The bioethical ethos drives IRB scrutiny ever stricter. Bureaucratized IRBs need thousands of members and burgeoning staffs just to manage paperwork, and researchers are similarly taxed (in some multi-site studies, 15% of the research budget pays for dealing with IRBs). Because this research “is how we produce the innovations that improve health, reduce morbidity or mortality, and alleviate human suffering, preventing or delaying research results in vastly more suffering and death than occurs from researchers’ ethical lapses.” Chapter 2 amasses and assesses evidence that IRBs delay, distort, derail, and deter research; hobble research training; and repel researchers from fields IRBs regulate.
Keywords: Research regulation, Regulatory costs, Bureaucratization, Licensing, Prior licensing, IRBs, Multi-site studies, IRB delay, Bioethical ethos
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