INSTITUTIONAL REVIEW BOARD EVALUATION OF NEUROSCIENCE PROTOCOLS INVOLVING HUMAN-SUBJECTS

We analyzed our Institutional Review Board's (IRB) critiques of neuroscience protocols to identify areas of difficulty for investigators. Minutes from IRB meetings were reviewed, and criticisms were collated under applicable Code of Federal Regulations sections, coalescing into four categories: procedural issues, protocol critique, consent critique, and patient rights. Better communication with research subjects would have avoided a majority (66%) of criticisms. Procedural criticisms could have been reduced by adherence to IRB technical requirements. The small number of protocol design criticisms suggests either a lack of rigor in committee analysis or reliance on prior reviewers; it may also reflect the ongoing debate about the role of the IRB in evaluating scientific merit.