A new pathway for the regulation and governance of health research

At a glance

Health research depends on regulation and governance that protects participants while enabling valuable studies to take place. This report set out a vision for a simpler, more proportionate and better coordinated system that would reduce unnecessary bureaucracy and support high-quality research for public benefit.

Published: January 2011

Summary

The UK has long been a world leader in health research, but the report argued that an overly complex regulatory and governance environment was undermining its competitive advantage. Delays, duplication and inconsistent requirements across approvals, permissions and authorisations were increasing costs, slowing studies and making the UK a less attractive place in which to carry out research.

The evidence gathered for the review highlighted the scale of the challenge. After funding for a study had been agreed, it was taking an average of 621 days to recruit the first patient in a Cancer Research UK study. The report also pointed to a sharp decline in the UK’s global share of patients in clinical trials, which fell from 6% to 2–3% between 2000 and 2006.

In response, the report called for a more proportionate, efficient and coordinated pathway for health research, underpinned by four principles: safeguarding participants, facilitating high-quality research for public benefit, ensuring that processes are proportionate and coordinated, and maintaining public confidence through independence, transparency and accountability.

Its most significant recommendation was the creation of a new Health Research Agency to simplify the approvals landscape and provide a single point of entry for applications.

The report also argued that the new body should improve the regulation of clinical trials, streamline research governance in the NHS, and support more consistent access to patient data and tissue for approved research.

Many of the principles set out in the report remain highly relevant today. Proportionate regulation and effective governance are still essential to enabling innovation, maintaining public trust and ensuring that research can deliver benefits more quickly and efficiently.

What's happened since

The report helped shape a major shift in the UK’s approach to health research regulation and governance. In particular, it informed the creation of the Health Research Authority, which has played a central role in simplifying ethics and governance processes, improving consistency and supporting a more streamlined research environment.

The challenges identified in 2011 continue to resonate today, including the need for proportionate regulation, clearer and faster routes through approvals and permissions, better support for research in the NHS, and more effective use of health data for approved research.

Building on the report’s recommendations, we continue to contribute to debates on regulation and system reform through our Forum, including work on regulating artificial intelligence (AI) and computational models in clinical trials that has helped inform Medicines and Healthcare products Regulatory Agency (MHRA) thinking on risk-proportionate, innovation-enabling approaches.

Together, these developments demonstrate the report’s lasting influence and show how its recommendations continue to shape discussions on clinical trials, research governance and wider system reform.

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Work with us

To create a research environment that is robust and enabling, there needs to be collaboration across policy, regulation, healthcare and research. We welcome opportunities to work with policymakers, researchers, healthcare leaders, regulators and others to build a more proportionate, efficient and trusted system for health research.

About this report

The report was chaired by Professor Sir Michael Rawlins FMedSci and informed by a working group of Fellows and experts from across research, healthcare, industry and policy. 

Fellows in the working group

Read the report

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