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Starting a new study?

Setting up a new study? What approvals do you need?

Does your study involve health or social care and involves NHS patients, their tissue or data?

Does your study involve the testing of a drug or device in any human being?

Is your study considered to be clinical research by the Health Research Authority?

While latterly focussed on student research, the HRA student decision toolkit can help answer the following core questions which help classify all health and social care research projects:

  • is my study research under the UK Framework definition?
  • is my research taking place in the NHS and will need NHS approval?
  • do I need NHS Research Ethics Committee (REC) review?
  • what type of NHS ethics review do I need?”

If the answer to any of the above is yes, and you are affiliated to UCL or UCLH, then it is likely that your study requires an approval from UCL or UCLH and potentially a regulatory body before it can start.

There are typically three stages of approval that must be considered before conducting clinical research:

The JRO and UCL Clinical Trials Units (CTUs) will support researchers with the set-up of research studies. 

If you are a UCL or UCLH researcher conducting research in these categories, it is likely that you will need a sponsor. 

Granting of sponsorship does not automatically confirm regulatory approvals or approval for a study to take place at UCLH (NHS site Assess, Arrange and Confirm). All three stages are required. Each stage will provide a confirmation. Do not begin your study until all stages are in place. 

If you are a UCL or UCLH researcher, conducting research at UCLH or UCL and have already obtained sponsorship (UCL, UCLH or other such as commercial or other university), you will still need NHS Site Assess, Arrange and Confirm approvals.

Read the current JRO policy in place for how we are handling study authorisations and review.

The JRO will now be reviewing and approving requests for the renewal of NIHR CRN funding (existing posts and like-for-like replacements). The Central and East London LCRN will continue to review applications for new posts. Read more about the renewal of NIHR CRN funding.

Student research

Student research means studies which are primarily for the purpose of obtaining an educational qualification.

Current HRA guidance on student research is on the HRA website. There are new eligibility criteria for student research from 1 September 2021. For queries, contact the JRO on uclh.randd@nhs.net.

Research Tissue Bank or Research Database

Researchers wishing to set-up a Research Tissue Bank or Research Database should contact the JRO in the first instance to discuss their proposals.

Brexit

For information and FAQs on how Brexit may affect your research, see our dedicated Brexit page.

For queries or questions contact the JRO on uclh.randd@nhs.net or visit the Health Research Authority website.