Research Ethics and Governance

Relevant background documents for protocol development 

NIHR clinical Trials toolkit Use this to plan a clinical study, apply for ethics and monitor progress.

Protocol guidance and template for use in a Clinical Trial of an Investigational Medicinal Product (CTIMP) 

Protocol guidance and template for use in qualitative research


IRAS Integrated Research Application System common gateway for ethics, R&D, MHRA, SSI an other research-related approval processes.

Keele University Research Ethics guidance

Key documents and regulations

UK Policy Framework for Health and Social Care Research (update 30 Oct 2020: use this for UK)

The Medicines for Human Use (Clinical Trials) Regulations 2004 Statutory Instrument No. 1031

Research Governance

Research Governance Keele University summary (short and informative, good start)

Data Protection

Data Protection Act 2018

Data Sharing

Guidance on data sharing, developing a repository, and data sharing agreements