Research approvals

Every study needs the right approvals before it can start. The approvals you need will depend on the nature of your research.

Is my project research?

Research Ideas around a table

  • Before applying for any approvals, you should determine whether your project qualifies as research.
  • Use the HRA decision tool to check.
  • If your project is classified as a service evaluation or clinical audit, different approvals may apply. If your research is based in NHS Lothian, contact the Quality Improvement Team for advice.

Do I need a Sponsor?

Jigsaw puzzle

  • All health and social care-related research needs a Sponsor, with some exceptions - systematic reviews, studies using aggregated publicly available data and studies evaluating student educational needs/methods.
  • If you are using samples or data from a research tissue bank or database, a Sponsor may be required, even with existing ethics approval.

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Research ethics

  • Most research requires a favourable opinion from a Research Ethics Committee (REC).
  • If your study involves NHS patients, tissue, data, or facilities, you’ll need an NHS REC opinion.
  • If there's no NHS involvement, you may still require University REC review. Within the Edinburgh Medical School, the Edinburgh Medical Research Ethics Committee (EMREC) can advise or review.
  • There are other scenarios (e.g. Adults with Incapacity) that may require NHS REC approval even without NHS involvement. Your Sponsor Representative can advise.
  • Students: Check with your supervisor or programme lead about any additional approval requirements.

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NHS management approval

If your research involves NHS patients, data, tissue, staff, facilities or carers, you will need NHS R&D management approval from each host NHS organisation.

Applications can be made via the Integrated Research Application System (IRAS).

Regulatory approvals

MHRA logo

You’ll need regulatory approval if your project is:

  • A Clinical Trial of an Investigational Medicinal Product (CTIMP)
  • A Clinical Investigation of a Medical Device (CIMD)
  • A combined drug and device trial

Our Clinical Research Facilitators will support you with preparing a combined review submission to the Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency (MHRA).

Other approvals

Checklist surrounded by researchers

Depending on your project, additional approvals may include:

  • Administration of Radioactive Substances Advisory Committee (ARSAC) – for the use of radioactive substances
  • Public Benefit and Privacy Panel (PBPP) – for multi-site access to unconsented data
  • Confidentiality Advisory Group (CAG) – for accessing identifiable, unconsented data in England/Wales
  • Caldicott Guardian (Scotland) – for single-site access to unconsented data. Submit a Caldicott Guardian Application Form to accord@nhs.scot.

Phase I and ATMP committee approvals

  • Phase I Study Review Committee (PISRC)
  • Advanced Therapy Gene Modification Safety Committee (ATGMSC)

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If in doubt, ask us

This list of approvals is not exhaustive. Always speak to your Sponsor Representative for tailored advice.

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