Initiating research led by St Georges
All clinical research follows a series of pre-defined standards. This guide will help you to manage the process appropriately.
Is your proposal research?
The first step is to determine if your clinical project can be categorised as research.
Not every clinical project will be research. Some proposals may fall under other categorisations and therefore will be managed in a different way.
The Health Research Authority (HRA), along with the Medical Research Council (MRC) has published a decision making toolkit (http://www.hra-decisiontools.org.uk/research/) to determine whether a project is classified as research under the definition of the UK Department of Health and Social Care.
The outline below should help you understand how to manage your proposal based on its categorisation:
Sponsorship: required. Depending on who you are employed by and why you are undertaking the project, your sponsor will be St. George’s, University of London or St George’s Hospitals NHS Foundation Trust.
HRA approval: required, unless you are not using patients/services/space within the NHS (this may include NHS provider services).
Ethics approval: required (ususally national ethics)
Confirmation of capacity and capability (NHS R&D approval) / site approval: required from every site undertaking protocol outlined activity
Sponsorship: not required.
HRA approval: not required.
Ethics approval: required only if you are using patient-facing documents.
Confirmation of capacity and capability (NHS R&D approval) / site approval: not required but needs to be registered with the audit department
Sponsorship: not required.
HRA approval: not required.
Ethics approval: not required.
Confirmation of capacity and capability (NHS R&D approval) / site approval: not required, but needs to be registered with the audit department.
If you are unsure whether your work should be defined as research, service evaluation or “other” please contact the JRES research governance team.
If the project is research, the following will apply.
Chief investigator (CI)
The person with overall responsibility design, conduct and reporting of a study.
Principle Investigator (PI)
The person delegated responsible for the leadership and conduct of a research study at their site
Site research delivery team
Members of the research team (other than the CI and PI) who support and/or undertake research-related activity. The CI and or PI are responsible for delegating out tasks on the study to appropriately trained/qualified individuals within the research delivery team.
The organisation taking the lead in assuring the study (insurance, compliance, finance etc). For St George’s-led research projects this will either be St George’s, University of London or St George’s University Hospitals NHS Foundation Trust.
The organisation (commercial company, research council, charity, trust etc) providing the money and/or equipment and/or resources to undertake the project. Visit our funding team pages to find out more.
Different studies in different setting will require different types of training. It is expected the chief investigator is a specialist within the subject and/or patient population the study is looking into. The principal investigator should equally be experienced with the same subject matter and patient population within their respective site. This should be evidenced by their CV. There are many online training opportunities available free to clinical researchers. Please visit the Medical Research Council (MRC) and Health Research Authority (HRA) for further resources.
For clinical trials (drug and/or device) that are sponsored by St George’s, the CI, PI and research teams must have attended a recognised Good Clinical Practice (GCP) training course. The National Institute of Health Research (NIHR) online and face-to-face course is available free to UK-based researchers.
Approvals before you start
The regulatory and governance approvals you need to apply for will vary depending on the type of study, participants involved and research sites.
- Sponsorship (this may be St Georges Hopsital or University if the study is lead by us)
- Protocol Management
- Compliance i.e Human Tissue, GDPR/Data Proection etc.
- Information sheets/consent forms
- Health Research Authority
- NHS/Social Care REC
- St Georges (Uni) Research Ethics (for non-clinical internal projects only)
All clinical research requires formal sponsorship before a study can progress to the HRA approval process. The JRES Research Governance and Delivery team provides guidance on the St Georges sponsorship application process.
All research which falls within the scope of the UK Policy Framework for Health and Social Care Research requires a sponsor. The sponsor organisation agrees to act as guarantor for the research ensuring that it is designed, conducted and reported to internationally recognised principles of Good Clinical Practice (GCP) and relevant legislation1.
Sponsorship should be discussed and agreed as early as is possible in the study set-up. Ideally a sponsorship request should be made at the time the research protocol is being developed or at the grant application stage. Formal declaration from the designated sponsor is required before any application to the Research Ethics Committee (REC), NHS R&D and other regulatory authorities can be made.
How to request St Georges sponsorship
Sponsorship should not be assumed.
Requests for sponsorship of all non CTIMP(drug) and or Device trials should be submitted formally by emailing the email@example.com . Please insert “sponsorship request” into the subject line.
You will have to include the following documentation BEFORE the review can commence:
- Draft completed IRAS/Ethics form
- Draft Protocol within St Georges templates (please see standard templates page)
- CV of Chief Investigator
- Draft Patient/Participant Information Sheets (PIS) , Consent Forms (PCF) , GP letters, invitation letters (please see standard templates page)
- Draft SoECAT (required for all non-commercial studies to be based within the NHS/Health sector regardless of funding – please consult your JRES Funding Officer)
- Details of study level funding
Funded Projects: 2-3 weeks
Unfunded projects: 4 plus weeks
Due to the timelines on publicly and or charity funded projects these will be prioritised
What we will not sponsor
The JRES will not process a request for sponsorship where:
- the CI is not a substantive employee of St Georges University of London and or St Georges University Hospitals NHS Foundation Trust, or
- the academic supervisor/accrediting institution for an educational project is not St Georges University of London.
- The study protocol has been written and led by another institution (nationally or internationally)
- Appropriate funding and or study management processes are not available
What about Drug and Device Trials?
For Drug (Clinical Trial of an Investigational Medicinal Product (CTIMP)) and or regulated device trials, the request for sponsorship should be made directly, by the CI, to the Head of Research Governance and Delivery or Research Development and Governance Manager within the JRES and PRIOR to any grant submission.
The decision on whether a St Georges is willing to sponsor a research study will be made on a case-by case basis following receipt and review of a valid sponsorship request.
For clinical trials, the JRES will formally delegate certain responsibilities to the Chief Investigator through a Delegation of Responsibilities Agreement; this agreement must be signed to acknowledge that s/he understands the responsibilities delegated prior to the study being activated.
As sponsor representative office for both SGUL and St Georges University Hospitals NHS Foundation Trust, the JRES retains the right to withdraw or suspend sponsorship at any time if deemed necessary
Help with documentation
The JRES has a number of templates and Standard Operating Procedures (SOPs) to help researchers structure their documentation when applying for sponsorship and for regulatory and ethical approvals.
The protocol should contain a full description of the research study and will act as a ‘manual’ for members of the research team to ensure everyone adheres to the methods outlined. It will be used by St George’s and/or regulatory and ethical bodes to monitor the study’s progress, ensure adherence and evaluate its outcomes. It will be an evolving document as the study progresses, so it should be kept up-to-date and include a version number and approval history.
Whilst no two research protocols will be the same, there are common elements and items that need to be addressed. The protocol is one core document of your minimum application pack. For a copy of the appropriate template relevant for your study please see our templates table.