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Regulation and good practice

Last reviewed 
31 July 2013

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 do not 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 a 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 tissues

Experimental Medicines Toolkit

  • Experimental medicine is research undertaken in humans to understand how diseases develop, or demonstrate proof-of-concept information. It is often done before clinical trials, and although it may involve NHS patients.

NIHR Research Design Service (RDS)

  • The RDS helps researchers to develop and design high quality clinical research applications. 

Universities UK' Innovation Explorer

  •  an online map of health-related research infrastructure showing geographical connectivity, or 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

Organisations

Health Research Authority (HRA)

Human Fertilisation and Embryology Authority (HFEA)

  • HEFA regulates the use of gametes and embryos in fertility treatment and research. Approvals for research are managed via IRAS.

Human Tissue Authority (HTA)

  • 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)

  • 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.

National Research Ethics Service (NRES)

  • NRES is in charge of ethical review of all research involving NHS patients, their tissue or data. Researchers apply for ethical review via the Integrated Research Application System (IRAS)

NIHR Clinical Research Network (NIHR CRN)

  • The 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.