Our policy on research regulation
Medical research involving patients is one of the most heavily regulated sectors in the world.
Regulation ensures that patients are protected when taking part in research and that the data generated from research is robust and applicable to future clinical practice.
Our policy team works with researchers and regulators to ensure that the regulation that governs research is proportionate – protecting patients whilst ensuring unnecessary red tape does not impede our researchers.
In recent years the research community has highlighted numerous ways that European and UK laws along with processes in the NHS have damaged their ability to run clinical trials and research studies. This is because excessive or unnecessary regulation can slow down or stop clinical research taking place as well as greatly increase the cost to funders.
We’ve recently seen commitments from both the UK government and the EU to improve the situation for medical research. In the UK the formation of the Health Research Authority and a renewed focus on improving the approval times for research in the NHS are already having positive effects on our availability to conduct research. At an EU level the new Clinical Trials Regulation will make it easier and faster to set up a clinical trial and promote collaboration across Europe.
We also work on other regulatory issues including: management of human tissues, ethical principles of research, and development and availability of paediatric medicines.
Statement: UK health and research community welcomes way forward for scientific advice in Europe (May 2015)
Letter to European Commission President on vital need to maintain Chief Scientific Adviser Post (July 2014)
Joint Statement on the Commission’s proposals for the Clinical Trials Regulation
Response to EMA consultation on Good Pharmacogenomic Practice Guidance (August 2016)
Response to House of Commons inquiry into leaving the EU: implications and opportunities for science and research (August 2016)
Response to EU consultation on Ethical considerations for clinical trials on medicinal products conducted with minors (August 2016)
Response to EU consultation on Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs) (August 2016)
Response to EU consultation on Risk proportionate approaches in clinical trials (August 2016)
Response to EU consultation on Summary of clinical trial results for laypersons (August 2016)
Response to MHRA consultation on Guidance for companion in-vitro diagnostic tests (July 2016)
Comment on the UK Policy Framework for Health and Social Care Research (May 2015)
Response to the European Medicines Agency on the transparency addendum to the functional specifications for the EU portal and database (February 2015)
Cancer Research UK response to the Health Research Authority Strategy for Public Involvement (January 2014)
HRA’s Transparent Research Paper (June 2013)
Response to proposed updates to Declaration of Helsinki (June 2013)
Response to House of Commons Committee inquiry – Clinical Trials and Access to Data (February 2013)
Get in touch with our policy team to find out more information about our policy on supporting research.
Call our policy team for more information.