Regulation and governance of health research: five years on

The Academy, Cancer Research UK and the Wellcome Trust have published the report of the joint FORUM workshop on the regulation and governance of health research, held five years on from the Academy’s report on ‘A new pathway for the regulation and governance of health research’.

This workshop brought together participants from across the life sciences sector to explore developments in the regulatory and governance landscape over the past five years, and any new challenges arising, in three particular areas: Health Research Authority (HRA) Approval; regulation of clinical trials; and data privacy and governance. Key points of discussion at the meeting included:

• The overall improvements in simplification and coordination of NHS research governance, and the importance of striving to embed a research culture in the NHS.
• Difficulties of over-interpretation of guidance and the need for more proportionality such as in application of ICH Good Clinical Practice (GCP).
• Anticipated improvements to regulation of clinical trials through the EU Clinical Trials Regulation, and the need to address remaining burdensome or ineffective aspects of trials regulation
• Importance of a whole systems approach to regulation supported by end-to-end metrics across the research pathway.
• Access to health data remains a critical barrier.

The meeting report can be downloaded from the righthand side of this page.