Regulatory outline

  • Research & Development
    Research & Development (R&D) aim to improve the environment for health research by facilitating and encouraging sharing of best practice, and working with other organisations.  View info flow diagram.
  • NRES website
    The National Research Ethics Service (NRES) serves to protect the rights, safety, dignity and well-being of research participants.  NRES facilitates and promotes ethical research that is of potential benefit to participants, science and society.
    The NRES website has lots of useful information including an Application Process Flowchart www.nres.nhs.uk
  • IRAS
    The Integrated Research Application System (IRAS) is a single online system for applying for permissions and approvals for health and social care/community research in the UK which streamlines the process for seeking relevant approvals, as researchers are no longer required to enter details of a single project in separate application forms. www.myresearchproject.org.uk
  • All Wales Primary Care RMG for streamlined permission
    The new centralised Streamlined NHS Permissions Approach to Research – Cymru (SPARC) system is designed to provide a streamlined and consistent approach for obtaining NHS permission for primary care research studies in Wales. Further details are available online.
  • UK permissions flow chart
    The UK permissions flow chart, published by the Wales primary care RM&G office, describes the systems for NHS permission across the UK and is designed to help researchers with cross-border multi-centre projects. View UK permissions flow chart [PDF].
  • GafREC
    Governance arrangements for research ethics committees (GafREC)
    A document describing what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Department's responsibility and when review by these committees is required. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_126474
  • UK regulations for CTIMPs
    The legal requirements for a Clinical Trial of an Investigational Medicinal Product (CTIMP) are different to non-CTIMP studies. Further details regarding CTIMPs are available. http://www.crncc.nihr.ac.uk/workforce_development/learning_and_development/gcp/gcp_resource/types_of_study.
  • MHRA
    Any CTIMP conducted in the UK requires both clinical trial authorisation (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) and approval from an ethics committee. Full details are available on the MHRA website.
  • NIGB
    The National Information Governance Board for Health and Social Care (NIGB) is an independent statutory body established to promote, improve and monitor information governance in health and adult social care. The NIGB provides advice on the appropriate use, sharing and protection of patient and public contributor information.  Please see the NIGB website for further information.
  • UKCRN
    The UK Clinical Research Collaboration (UKCRC) Partners’ goal is to establish the UK as a clinical leader in clinical research and aims to benefit the public and patients by improving national health and increasing national wealth. Full details of the UKCRN are available on their website.
  • Research passport
    When research is carried in the NHS setting, the Research Passport system issues honorary research contracts (HRCs) or letters of access to Higher Education Institute (HEI) researchers who need to undertake their research within the NHS. The Research passport provides a streamlined approach for obtaining permission for research from NHS organisations and provides evidence of the pre-engagement checks undertaken on the researcher within the NHS outside of their employing Trust. For further information, please see the following website http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx.