Managing a research study

The primary aim of research is to derive new knowledge that can be generalised to a majority of people or cases, whereas the aim of audit and service evaluation projects is to measure standards of care.

If you would like advice from the research and development team about your study, please contact us as early as possible. A member of the team will be allocated to discuss your project with you and give advice. 

You can also determine whether your study is a research study by using this decision-making tool from the NHS Health Research Authority, and whether it will require an ethics review from an NHS Research Ethics Committee via their decision tool.

All research studies require a sponsor organisation to take on the responsibility for the initiation and management of the study. 

Research sponsors are responsible for the review of research applications to ensure they have passed appropriate scientific quality standards, ensuring the study has ethical approval before it begins and, where required, seeking a clinical trial authorisation. 

We currently act as sponsor to the following types of studies: 

• basic science study involving procedures with human participants 
• administering questionnaires/interviews for quantitative analysis, or using a mixed quantitative/qualitative methodology 
• involving qualitative methods only 
• limited to working with human tissue samples (or other human biological samples) and data (specific project only) 
• limited to working with data (specific project only) 
• research tissue bank 
• research database 

If you need to identify a sponsor for your research study, please contact the research and development team as early as possible. A member of the team will be allocated to discuss your project with you and give advice. 

If your study is eligible for Royal Free London sponsorship, a member of the research and development team will facilitate a sponsorship review. 

Most research studies taking place in the NHS require a review by the NHS Research Ethics Committees (NHS RECs). 

NHS RECs are independent committees established under the umbrella of the National Research Ethics Service, part of the Health Research Authority. 

REC review is required if a research project involves:

• potential research participants identified from, or because of, their past or present use of health and social care services 
• potential research participants identified because of their status as relatives or carers from users of these services
• collection of tissue or information from users of these services
• use of previously collected tissue or information from which individual past or present users of these services could be identified

RECs are not expected to review:

• applications in respect of activities that are not research, for example clinical audit, service evaluation and public health surveillance
• research involving health and social care services staff, recruited by virtue of their professional role, except where it would otherwise require REC review

Applications for a review by RECs are submitted by the chief investigator on the national REC application form within the Integrated Research Application System. 

Health Research Authority (HRA) approval is required for all research in the NHS in England. 

It is a process that comprises of a review by a research ethics committee as well as an assessment of regulatory compliance and related matters undertaken by HRA staff located in centres around England.

HRA approval includes a study-wide review in line with UK-wide agreed standards and also new assurances including the co-ordination of clinical support assurances for radiation and pharmacy.

Once HRA approval is in place and local capacity and capability is agreed, sites will be able to confirm with the sponsor their readiness to recruit and the study will be able to start at that site.

Applications for HRA approval are made using IRAS (integrated research applications system) and are e-submitted directly to the HRA through IRAS. Study documents to sites are to be provided directly from the sponsor.

The following types of regulatory reviews might also be required for your research:

• Gene Therapy Advisory Committee: gene therapy clinical trial
• Social Care Research Ethics Committee: social care research studies
• Ministry of Defence Research Ethics Committee: research involving the UK armed forces
• Higher Education Institution Research Ethics Committees: some studies undertaken by researchers in higher education institutions, typically those are not reviewed by NHS RECs
• Confidentiality Advisory Group: research requiring access to confidential patient information without consent
• HM Prison and Probation Service: research taking place in prisons and probation trusts
• Administration of Radioactive Substances Advisory Committee: research involving the administration of radioactive materials
• Human Fertilisation and Embryology Authority: research involving human embryos and gametes
• Medicines and Healthcare Products Regulatory Agency (MHRA):
  • A Clinical Trial Authorisation is required for any clinical trial of an investigational medical product to be conducted in the UK that fall within the scope of the EU Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004.
  • An application to MHRA devices is required where the study is a clinical investigation of a medical device of a non-CE marked product or an investigation of a CE marked product that has been modified or is to be used outside its intended purpose.

For more information, see the NHS Health Research Authority website.

External researchers with no contractual arrangements with the Royal Free London are required to apply to the research and development department to obtain access to the trust premises, patients and patient data.  

Depending on your circumstances and the nature of your research study, the following access documents might be issued:

• Honorary Research Contract: for researchers who plan to undertake research which requires access to patients and identifiable patient data and has a direct bearing on the quality of patient care (for example provision of healthcare, personal care and guidance on wellbeing).
• Letter of Access: 
  • extension of NHS terms of employment for an NHS employee undertaking research in another NHS organisation
  • employee of a higher education institution with no contractual arrangement with the NHS who plans to undertake research which requires access to NHS premises, or access to patients and patient data with no direct bearing on the quality of care, (for example qualitative interviews, focus groups, on-site analysis of patient data).

Please make your application to rf.randd@nhs.net.

The government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. 

The aim is to increase the number of patients who have the opportunity to take part in research and to enhance the nation’s attractiveness as a host for research.

Performance in Initiating and Delivering Clinical Research is an initiative by the National Institute for Health and Care Research that commits to the following:

• Initiation: it should take no more than 70 days from receipt of a valid research application to the recruitment of the first patient to the trial.
• Delivery: for all commercial clinical trials hosted by the trust, the agreed number of patients must be recruited within the agreed recruitment period. 

You can see how we are performing in relation to the above on the National Institute for Health and Care Research website.