Written question WQ99940
- Asked by
- Cai Parry-JonesReform
- To be answered by
- Cabinet Minister for Health and Care
- Tabled
- Due
- Answered
- Time to answer
- 13 days
Question
What assurances has the Cabinet Minister sought that health boards participating in clinical trials involving multi-system diagnostic imaging have appropriate procedures for identifying, communicating and following up incidental findings?
Answer
Answered by Cabinet Minister for Health and Care (Mabon ap Gwynfor)
The Welsh Government expects health boards to deliver clinical trials in line with all ethical, regulatory and governance requirements, including approved arrangements for identifying, communicating and following up incidental findings.
The Health Research Authority oversees governance and ethics review, while the Medicines and Healthcare products Regulatory Agency authorises and regulates clinical trials of medicines. The Medical Research Council is not a regulator but provides guidance on managing health-related findings. Health boards must ensure trials follow the approved protocol and participant safety arrangements.