The regulatory and governance environment for clinical research and experimental medicine studies is complex and changing. Researchers need to understand and comply with a wide range of legal requirements and keep up-to-date with changes in the environment. The sections below and the links contained in them direct you to sources of guidance and information.

What are the regulatory & governance requirements for experimental medicine studies?

Investigators need to determine which good practice guidelines and statutory requirements apply to their research study. The MRC Regulatory Support & Centre in Edinburgh is developing an Experimental Medicine Toolkit to provide guidance on the requirements and guidelines that apply to experimental medicine studies.

In addition the MRC Regulatory Support Centre has developed a Data and Tissues Toolkit to provide 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, e.g. Data Protection Act (1998), Human Tissue Acts.

Where can I get specific advice about regulatory and governance issues?

The UKCRC Regulatory and Governance Advice Service, which is coordinated by the UKCRN and the MRC Regulatory Support Centre, is a UK-wide resource which is intended primarily to support local advice providers in health research (including non-portfolio studies), such as NHS R&D departments, university research managers, MRC grant holders and employees or Clinical Trial Unit staff without access to R&D offices within the NHS or universities.

How is the regulatory and governance environment changing?

The UKCRC provides an umbrella under which activities to streamline the regulatory and governance environment are negotiated, brought together and coordinated. The UKCRC has a number of initiatives underway to effect consistency and standardisation in process, interpretation and advice. For further information refer to the UKCRC Regulatory and Governance Environment web pages.