Recommendation BRIS-100: Mandate ethics committee approval for all new untried invasive clinical procedures
From Bristol Heart Inquiry — Final Report, published 18 July 2001.
Recommendation
Before any new and hitherto untried invasive clinical procedure can be undertaken for the first time, the clinician involved should have to satisfy the relevant local research ethics committee that the procedure is justified and it is in the patient’s interests to proceed. Each trust should have in place a system for ensuring that this process is complied with.
Government response
No government response to this recommendation is on the record yet.
Delivery
DHSC and NHS England say in progress (27 February 2026)
The Royal College of Surgeons has issued a guide to good practice on surgical innovation and new techniques.
This guidance indicates that surgeons must follow local protocols for obtaining approval by the local ethics committee or the local clinical governance committee.
Site note: DHSC and NHS England's own account of progress, supplied to the Thirlwall Inquiry in September 2024 and printed in the Inquiry legal team's Review of Implementation of Recommendations from Previous Inquiries into Healthcare Issues (version dated April 2025, published 27 February 2026). It is not a finding of the Inquiry. Their reviewed extent of implementation reads “Implemented – Ongoing”. Table row: section 6.2 No. 100, PDF page 115-116.
What other bodies have found
In their own words. These do not change the delivery statement above.
Thirlwall Inquiry legal team (15 May 2024)
The Government agreed in principle with this recommendation.
In its January 2002 response, the Department of Health said that new interventional procedures would need to be overseen and scrutinised by the National Institute for Clinical Excellence from April 2002 and local research ethics committees would need to consider any studies of new procedures as advised by the National Institute for Clinical Excellence. The Department said guidance on the new arrangements would specify local systems for managing new interventional procedures and would be issued in 2002.
Site note: The Thirlwall Inquiry legal team's own notes on implementation, from its Review of Implementation of Recommendations from Previous Inquiries into Healthcare Issues (version of 15 May 2024). The review does not colour its Extent of Implementation cell for this recommendation green; it leaves the cell uncoloured where a recommendation was rejected, where evidence of implementation was insufficient, or where steps had been taken but implementation was not yet complete. Table row: section 6.2 No. 100, PDF page 104.
Themes and tags
Who has spoken
- DHSC and NHS England
Delivery statement - Thirlwall Inquiry legal team
Finding