When participating in a cooperative project with another institution, the CSS IRB may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort (45 CFR § 46.114 (c)).
The CSS IRB may agree to delegate the responsibility for initial and continuing review to another institution's IRB. In turn, that institution’s IRB agrees to assume responsibility for initial and continuing review.
This document describes a permissible mechanism under which an institution holding an Office for Human Research Protections (OHRP)-approved Federalwide Assurance (FWA) (hereafter referred to as The College of St. Scholastica [CSS] IRB as the assured institution) may extend – for one or more research protocols – the applicability of its FWA to cover two types of collaborating individual investigators: collaborating independent investigators and collaborating institutional investigators.
The purpose of this standard operating procedure (SOP) is to ensure that adverse and serious adverse events are defined, recorded, reported, and evaluated as required by the CSS Institutional Review Board (IRB). Principal Investigators are required to immediately submit to the IRB any unanticipated problems involving risk to human subjects or others. The notification to the IRB must occur no later than 2 weeks from the time of identification of the unanticipated problem.