Breach reporting to the REC

Catherine Blewett, HRA Improvement & Liaison Manager

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)

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

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

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

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

Thank you

catherineblewett@nhs.net