Regulation and governance of health research - follow-up

The Academy's report on  'A new pathway for the regulation and governance of health research' was first published in January 2011. Five years on, significant changes had taken place in the environment including the establishment of the Health Research Authority (HRA), a recommendation from the report, and preparations for the incoming EU Clinical Trials Regulation and the EU General Data Protection Regulation. Therefore the Academy, Cancer Research UK and the Wellcome Trust held a FORUM meeting on 1 November 2016 to explore progress five years on from the report, with a focus on three particular areas: HRA Approval; regulation of clinical trials; and data privacy and governance.

Key points identified 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.