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Most studies require an ethical review. Some studies will require additional regulatory reviews. The JRO (or Clinical Trials Unit) will advise on which reviews are needed. The main regulations applicable to clinical research are:
- Research Ethics Review
The vast majority of studies that involve human participants, their tissues or data should undergo a research ethics committee (REC) review and many research studies will require an NHS REC opinion. Please visit the HRA decision tool; Do I need NHS REC approval? for more information.
For non-NHS research please see UCL REC.
- GDPR
The General Data Protection Regulation (GDPR) came into force on May 25th this year.
Visit the Health Research Authority's website for more advice about what you need to do to comply with GDPR.
The Health Research Authority (HRA) requires investigators to provide additional information to research participants. This information tells participants how their data will be used.
All studies which are collecting new data will need to provide this information to participants. If you have stored data you should await further guidance.
The information which participants should receive will be placed in a separate document using the HRA approved templates (non-notifiable amendment) or within your existing patient information sheet (a substantial amendment is required). Sponsor's research teams are responsible for making these changes and also for notifying sites.
Information for CI's on all UCL and UCLH Sponsored studies
The JRO have prepared a step by step guide for Chief Investigators whose studies are UCL or UCLH sponsored studies. The guide should be read in conjunction with the information provided on the HRA website. The guide and the website will allow you to determine which changes will be required and provide you with templates to make these changes. If you are not making a substantial amendment then you must use the text verbatim.
If you are planning a new study but do not yet have approved patient information sheet, you should also incorporate the new requirements.
If you have finished collecting data but still undertaking the analysis no action is required at present.
Information for PI's on studies taking place at UCLH
In most cases, the Sponsor of the study is the data controller. Therefore you should expect any updated patient information to be sent to you from the Sponsor. This information should be given to participating patients (as per the instructions provided by the sponsor).
The JRO recommends that you make contact with your sponsor to enquire about their plans for disseminating updated patient information. Once received, please do forward the updated documents to the JRO, making the email clear that you have received updated GDPR patient information for a UCLH hosted study. You should also update your study file (refer to the guide on UCL and UCLH sponsored studies above for details on how to update files).
Further information can be obtained from our GDPR FAQs or by contacting uclh.randd@nhs.net
If you have prepared your transparency notice and what to check it a check list please see the Transparency Checklist below.
- HRA Approval
HRA Approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England.
- MHRA
The Medicines and Healthcare Products Regulatory Authority is the regulatory agency that reviews and authorises all Clinical Trials of Investigational Medicinal Products (CTIMPs) and Medical Device Trials with the intention of obtaining CE marking in the UK.
To find out if your study is a CTIMP or not, use the MHRA's algorithm 'Is it a clinical trial of a medicinal product?'. If you are still unsure please contact the JRO uclh.randd@nhs.net
For international CTIMPs, an application to the competent authority in the country of each trial site will be required.
- Other Approvals
Research involving the administration of radiaoactive substances will require authorisation from the Administration of Radioactive Substances Advisory Committee (ARSAC).
Clinical trials involving the administration medicines classified as genetically modified organisms (GMOs) will require review and approval from the local Genetic Modification Safety Committee at each trial site prior to commencement of the project.
If you intend to access confidential patient information without consent in England and Wales as part of your research you should also apply to the Confidentiality Advisory Group (CAG).
The JRO can help researchers prepare applications for REC and other approval bodies. Most regulatory approvals are submitted via the national system called IRAS.
For example, for studies involving administration of radioactive material, ARSAC (Administration of Radioactive Substances Advisory Committee) approval is required. For detailed guidance on how and when to submit please refer to Government guidance.
For queries or questions contact the JRO on uclh.randd@nhs.net or visit the Health Research Authority pages on the types of approvals required.
