Following the publication of the Academy's 2011 report on 'A new pathway for the regulation and governance of health research', the Academy, Cancer Research UK and the Wellcome Trust held a workshop five years on from the launch to explore progress. This forms part of the Academy's ongoing work on the regulation and governance framework for medical research.Status: Completed
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- Regulation and governance of health research - follow-up
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.
The Health Research Authority (HRA) was established following the Academy’s report on the regulation and governance of health research. The HRA’s Collaboration and Development Steering Group is a UK-wide group that supports the HRA with implementation of the unified approval process for the regulation and governance of health research in the UK, and helps to drive improvements to this process.
The Academy participates on this group, which enables us to feed into the processes around HRA Approval and the regulation and governance of health research more broadly. The Academy has also responded to HRA consultations such as providing input on its draft UK Policy Framework for health and social care (these responses can be found on the righthand side of this page).