Study wide governance criteria
Introduction
The Integrated Research Application System (IRAS) is the single system for applying for the permissions and approval for health and social care or community research in the UK.
Study-wide review provides assurances to NHS and HSC organisations that information relating to a study is accurate and that the study, as described in the application document set, is compliant with legislation relating to the research.
This is not an exhaustive list of checks, as individual studies may present their own questions. Where additional concerns are addressed for an individual study, this would usually be described in the study wide review made available to sites in Scotland and Northern Ireland and in the HRA and HCRW Approval letter in England and Wales.
Study wide reviewers should review against their national requirements only but should highlight in the study wide review where nation specific differences apply.
Where uncertainty exists, this should be escalated in line with nation specific processes.