When an external IRB is responsible for the oversight of a UAMS study, the UAMS IRB’s role in reviewing the study is very limited. However, we are required to do something called a “local context review,” which ensures the material seen by UAMS subjects is appropriate. Local context issues can be influenced by state law and by characteristics unique to our local study population.
Because of our local context responsibilities, the UAMS IRB asks that when you submit revised protocols or subject-facing documents to the IRB for acknowledgement, please either include tracked-changes copies showing the revisions, OR summarize what has changed from the previous versions. The “notes for IRB reviewer(s)” (click the link for a refresher on what this is) query on the modification form can be used to describe the changes. If we can’t tell what has changed in a document, we will have to return a contingency, so we can see whether the changes affect our local context at all.
Also, if you submit a revised consent form on an xIRB study, please indicate whether any locally enrolled subjects will be reconsented or otherwise provided the information included in the revision.