Clinical research involves people or the use of human tissue, cells or personal data and is subject to legislation, regulations and requirements. Many of these are in place to ensure that the rights, safety and dignity of those participating in the research are protected, and there is a drive towards standardisation across Europe, and with the US.

Researchers have complained that these regulations have led to an increase in bureaucracy, making it more difficult to undertake clinical research.

In response to this, partners within the UK Clinical Research Collaboration (UKCRC) have worked together to streamline the regulatory and governance environment and have produced a leaflet that describes the most recent of these initiatives.

Useful resources and organisations:

• Integrated Research Application System (IRAS) is a single system of applying for the permissions and approvals for health and social care/community care research in the UK.

• Clinical Trials Toolkit: toolkit devised to streamline the process of meeting the regulatory requirements for clinical trials. 

• Data & Tissues Toolkit: provides practical help with the legislative and good practice requirements relating to the use of personal information and human tissue samples in healthcare research in the UK, eg Data Protection Act (1998), Human Tissue Acts.

• The Human Tissue Authority licenses organisations that store and use human tissue for purposes such as research, and provides codes of practice along with advice and guidance on the implementations of the Human Tissue Act and the EU Tissue and Cells Directive. 

• The Medicines and Healthcare Products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medicinal devices work, and are acceptably safe.

• The Research Governance Framework for Health and Social Care governs research taking place in the NHS.

Updated February 2010