Approvals Outside the UK

By |October 22nd, 2015||

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 [...]

What patient/personally-identifiable data will this study collect, and why?

By |October 22nd, 2015||

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 [...]

Approvals Within the UK

By |October 22nd, 2015||

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 [...]