Need for submitting an ethics protocol for approval
The PancreasGroup.org International Liver Surgery Outcomes Study is an observational study without affecting the patient management.
Data collection is fully anonymised without any patient identifiers.
In many countries this study is considered as an audit (UK) or quality improvement program (USA), without necessitating a formal ethics approval.
However, each country, state, region or institution may have different regulations for gaining ethics permission.
In the UK, PancreasGroup.org does not require formal ethics approval and can be registered as an audit. Please click on the icon below to download the Royal Free Hospital Audit Committee Approval Letter:
The local investigators should seek advise from their own Ethics Committee or Institutional Review Board.