Clinical research involves patients, their tissue or cells or their data. It is subject to regulation and good practice to ensure that the rights, safety and dignity of participants is protected.

In the past decade, there has been an increase in the number of legal and best practice directives that govern how researchers work, and there is a strong desire to streamline the initiatives, so that they don’t create barriers to good quality research but do provide the protections patients deserve.

Resources

The MRC, NIHR and HRA support toolkits to help researchers and funders.

Clinical Trials Toolkit provides practical help to guide researchers to design and carry out clinical trials of medicines, including links to all approvals that are required.

Data and Tissues Toolkit helps researchers who are carrying out research using patient data or tissue.

Experimental Medicines Toolkit supports investigators, research managers and ethics committees in assessing the risks involved in experimental medicine studies and devising risk proportionate management and monitoring strategies.

NIHR Research Design Service (RDS) helps researchers to develop and design high-quality clinical research applications.

Universities UK's Innovation Explorer is an online map of health-related research infrastructure showing geographical connectivity to find organisations with a particular thematic interest.  So far, users can see Academic Health Science Networks (AHSN), Local Enterprise Partnerships (LEP). Clinical Commissioning Groups (CCG's) and Local Education and Training Boards (LETBs) will be added soon.

Ethical Review: ​The HRA have developed two tools to help researchers work out if their project is research and if it needs NHS REC approval.

Organisations

Health Research Authority (HRA) was set up in 2011 to create a unified approval process for clinical research and to promote proportionate standards for compliance and inspection. It manages the National Research Ethics Service and is piloting a single application package for both ethics and NHS permissions.

Human Fertilisation and Embryology Authority (HFEA) regulates the use of gametes and embryos in fertility treatment and research. Approvals for research are managed via the Integrated Research Application System (IRAS)

Human Tissue Authority (HTA) regulates organisations that remove, store and use tissue for research, medical treatment, post-mortem examination, teaching and display in public. Approvals for research are managed via IRAS.

Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines, medical devices, medicinal products containing gene therapies, cell therapies or tissue engineered products and blood products used in healthcare. It also investigates harmful incidents and regularly inspects organisations that host or sponsor clinical trial.

Research Ethics Service is in charge of ethical review of all research involving NHS patients, their tissue or data. Researchers apply for ethical review via the IRAS.

NIHR Clinical Research Network (NIHR CRN) provides the infrastructure that allows high-quality clinical research to take place in the NHS. The network structure is being modified and from April 2014 will be made up of twelve NIHR CRN themes that will work via six national thematic research delivery divisions and 15 local research networks.

NIHR INVOLVE supports public involvement in NHS, public health and social care research. It is one of the few government funded programmes of its kind in the world.