1. Breach reporting to the REC Catherine Blewett, HRA Improvement & Liaison Manager

2. Breach reporting to the REC The REC wants to be reassured about research governance to ensure the favourable ethical opinion remains valid and that good research is supported to continue What has happened, why has it happened, what is being done to put it right and what is being done to prevent the same thing from recurring? Gives confidence REC expectations - Timely and appropriate action taken by the research team / sponsor. - Action should be investigator / sponsor driven. Don’t wait for the REC to request action - Afforded a proportionate level of seriousness - Sponsors will take general, not just study specific, action when appropriate Why report violations and breaches? –Ensure individual incidents are dealt with –To have a wider overview –Identify areas to focus on (consent & compliance with inclusion criteria)

3. Review of all REC reported breaches – commonly occurring issues Recruitment outside inclusion criteria Unapproved/incorrect documentation being used Correct consent procedures not being followed Records not complete or inaccurate Correct approvals not in place Safety reporting errors Randomisation errors

4. Review of all REC reported breaches – commonly occurring causes Miscommunication Misunderstanding Lack of clear processes Staff pressures / Changeover of staff Confusion regarding current version of documents

5. Review of all REC reported breaches – Recommendations to take forward in the replacement for the Research Governance Framework Recommendations –The importance of well planned and written protocols and internal processes –The importance of protocols and internal processes being followed – The importance of good communication processes and lines of responsibility –The importance of document management systems or good version control –The need to ensure learning rather than just delivering training –The importance of encouraging open and honest reporting

6. Review of all REC reported breaches – Comments received Are all breaches reported? CTIMP / non CTIMP – the regulation effect – particularly when managing limited resources Differentiating between clinical practice and research procedures Clear responsibilities Difference between commercial and non commercial sponsors – particularly with audit and monitoring Quality – during planning stages and throughout the duration of the study – reduces unnecessary work Researcher & sponsor working relationship

7. Thank you catherineblewett@nhs.net