Box 1.

Key legal, regulatory, social and political events occurring at the time of the Delphi study

The Care Act 2014, which established the Health Research Authority (HRA) as a non-departmental statutory body with responsibility for health and social care research governance

The failure of the ‘care.data’ patient data sharing regime and subsequent concerns regarding information governance in NHS England

UK implementation of revised Caldicott principles regarding information governance in the health sector, specifically the handling of patient-identifiable information

Drafting and subsequent implementation of new EU General Data Protection Regulation (Regulation EU 2016/679)

New EU regulation of clinical trials on medicinal products for human use (Regulation EU 536/2014)

New EU regulations of medical devices (Regulation EU 2017/745) and in vitro diagnostic medical devices (Regulation EU 2017/746)

Changes to HRA regulatory approvals system, namely HRA Approval, bringing together the assessment of governance and legal compliance

Brexit (i.e. the potential withdrawal of the United Kingdom from the European Union)