Module 15 2022

20/05/2022

Ethical Approval in UK

Should be submitted at the same time as the MHRA application.

How to apply: 1. Applications must be made via the Integrated Research Application System (IRAS). 2. Complete the HRA/EC Clinical Investigation Application form on IRAS and upload the relevant supporting documents 3. Call up the Central Booking Service (CBS) submit. 4. The REC will issue a validation letter within 5 working days, to confirm the application is valid. 5. The REC have a requirement to provide an ethical opinion on an application within 30 calendar days (14 days after the meeting)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

49

Health Research Authority HRA Approval - align the Research Ethics Committee approvals process with what was NHS R&D approvals, to reduce duplication – now have a single HRA assessment

Major review of Research Governance Framework … the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

50

25