Collaborators are individually responsible for ensuring that all normal processes of study approval are correctly followed. Collaborators will be asked to confirm that permissions are all obtained before commencing data collection and submission. As above, this study is best regarded as a global audit; we are collecting data that is already available routinely, and are [...]
Our protocol outlines our intention to use the patient-identifiable variables of age, gender and patient identification number. Age of the patient is essential to meaningful interpretation of data. We believe this poses less risk of inadvertent patient identification than collecting date of birth. Gender is an essential prerequisite for meaningful analysis of our data and carries negligible risk of [...]
Within the UK, GlobalSurg 3 was assessed by the South East Scotland Research Ethics Service who defined the study as audit (reference NR/161AB6 ), therefore it was not necessary to obtain full NHS ethical review. UK collaborators still need to obtain local NHS Trust/Board and consultant approval. Collaborators based in England, Wales and Northern [...]
Within the UK, this is not required since this study has been classed as an audit and does not require any change to routine care. We do not think it likely that patient-level consent will be necessary in other jurisdictions, but the advice of local authorities should be followed.