The IRB has revised its policy 1.4, titled Studies Requiring Review and Human Research Determinations. This policy describes the UAMS IRB’s review and oversight responsibilities, its ability to cede those responsibilities when applicable, and the process for determining whether a project is human subject research requiring IRB review.
The more notable changes include adding a definition of a “clinical trial,” as described in the Revised Common Rule, and removing the limit of 3 cases in a case series, as we are not quite sure where that number came from. The issue of whether something is a “systematic investigation,” as the regulations put it, are more helpful in determining whether something is research than the number of cases involved.