Monthly Archives

September 2016

Last month, NIH released the “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research”. They have coined this process as the “sIRB”, making it sound somewhat fashionable . The policy requires that only one IRB hold the responsibility for multi-site projects, leaving the oversight of the study to one site only. While there are indications that the sIRB will be part of the revisions to the Common Rule later... Read More
One of the more frequent (and frankly just) complaints) about IRBs is that they involve themselves to deeply in reviewing and often modifying the scientific design of a study, sometimes to the point of r adically re-writing the protocol. There are circumstances where the IRB does need to evaluate the scientific design, and there are other circumstances where it should not get involved in these questions. A look at the regulations provides little guidance. The question of... Read More