We’re still cranking out the revised policies here at IRB Policy central. Newly posted are:
IRB Policy 1.1, which describes the IRB’s principles and authority. We’ve added language about International Conference on Harmonization (ICH) guidelines. ICH guidelines are a standards many clinical trials involving investigational products follow. At UAMS, studies for which the institution holds an IND or IDE, and industry-sponsored clinical trials, are those typically subject to ICH guidelines.
IRB Policy 6.5, describing IRB record-keeping practices. This policy replaces the old policy 5.1. In fact, with this switch, we’re retiring section 5 altogether. We never quite understood why we had both a “Recordkeeping” AND a “Documentation” section. Well, we don’t have both anymore.
IRB Policy 17.13, describing who can serve as a legally authorized representative to provide consent/permission for research participation. The changes include clarifying how, exactly, someone can be named as a surrogate to make decisions on someone else’s behalf, and fixes some formatting issues.