Research at University Hospitals Sussex is conducted in accordance with strict policies and procedures to ensure high standards are maintained. The regulation of health research provides participants with the reassurance that any research they take part in will be of high quality. Robust regulation also ensures that the results of research can be relied upon and used as evidence to inform future decisions about healthcare and treatment.
The following information will help you plan and prepare before you apply for your research approvals. Not doing so may mean that you encounter unnecessary delays and complexity.
As a minimum, all research studies must:
- Have a sponsor – to ensure an organisation or partnership takes responsibility for confirming there are proper arrangements in place to initiate, manage, monitor and finance the study.
- Have ethical approval – to protect the dignity, rights and safety of participants.
- Have Health Research Authority (HRA) approval – to ensure governance and legal compliance.
- Have management permission from the NHS organisation hosting the research – to ensure the site has assessed, arranged and confirmed its capacity and capability to deliver the study.
- Have secured funding – either external or internal.
Your study may require review by other regulatory bodies. Further information to help you determine if additional approvals are necessary can be found on the Health Research Authority website.
Once your study has sponsorship, it is recommended that you apply for the other approvals in parallel. Applications should be made using the Integrated Research Application System, for which you will need to have an IRAS account.
Steps in the approval process
The precise steps involved in the approval process may change in response to new directives. The following information therefore serves as a guideline – you should contact the Research & Innovation (R&I) Department before undertaking any research activity to ensure compliance with current requirements.
Most research conducted at UHSussex will require an independent Research Ethics Committee (REC) opinion provided through the HRA’s research ethics service. This is applied for via IRAS and is incorporated into the HRA Approval process. Further information on REC review requirements / exemptions can be found on their website.
Studies exempt from REC review may still require ethics review by a higher education Iistitution. All students and researchers employed by universities must check their university’s internal policies.
HRA approval is the process that brings together the assessment of governance and legal compliance for the NHS in England, and was fully implemented on 31 March 2016. HRA approval is undertaken by dedicated HRA staff, and replaces the need for local checks of legal compliance and related matters by each participating organisation. HRA approval assures NHS sites that the study has been reviewed and ratified by all the applicable regulatory bodies and therefore allows sites to focus their resources on assessing, arranging and confirming their capacity.
For more information on HRA approval and the application process please their website.
Please remember to inform the R&I Department of your intent to apply for HRA Approval so that we are aware of your plans.
NIHR CRN Support
If you would like your project to be considered for National Institute for Health Research (NIHR) Clinical Research Network (CRN) support and inclusion on the NIHR CRN Portfolio, you must answer ‘yes’ to question 5b of the IRAS Project Filter – this will ensure that information from the IRAS submission is automatically shared with the NIHR. Please note that Portfolio Adoption Forms are no longer required and were removed from IRAS in November 2020.
If you are setting up an English-led Clinical Trial of an Investigational Medicinal Product (CTIMP) then you must apply for CRN support through the new non-commercial portfolio application service.
If your study does not require HRA approval, for example through running outside of NHS settings, then you can now apply for NIHR CRN support via the non-commercial portfolio application service. Please ensure you have discussed your study with CRN Kent, Surrey & Sussex prior to application.
NHS research management approval
Alongside seeking HRA Approval, researchers / Contract Research Organisations (CROs) wishing to conduct research in the NHS in England need to inform the NHS organisations in which they wish to conduct their study so that those organisations can confirm:
- they have the capacity and capability to deliver the study
- arrangements are in place to do so
- they are ready to start the study
You are expected to discuss the project with the local research team and the research management staff supporting them before the HRA Approval application is made: we can begin to assess our capacity and capability to support you. It is vital that the R&I Department is copied into the correspondence with the local research team, so that we can help you determine what steps you need to take and when. In this way, we aim for study set-up to be a collaborative and efficient process.
Once a submission has been made to the HRA, the following document package needs to be sent to the study team and research management team:
- Copy of IRAS Form (combined REC and R&D form) as submitted for HRA Approval
- Protocol (and amendments, if applicable)
- Participant information and consent documents (without local logos/ headers)
- Relevant model agreement
- Commercial studies only – NIHR Costing template (validated) and delegation log (including known research team names but not signatures)
- Non-commercial studies only – Statement of Activity and Schedule of Event templates (including known information)
- Any other documents that the sponsor wishes to provide to support the set up and delivery of the study
- Copy of HRA Initial Assessment Letter (if one is issued) and (when issued) HRA Approval Letter and final documents
The study sponsor is responsible for providing us with the most up to date documents and copies of approvals, in order to facilitate study set up.
NHS research management permission will be sent via email, usually shortly after HRA approval has been granted. You must wait for the management permission email confirming ‘capacity, capability and readiness’ before you can commence your research. This assures you that contractual and financial arrangements have been finalised, internal support department approvals have been received, relevant HR arrangements are in place, and the study documents have been localised ready for use.
Working with human tissue – the Human Tissue Act
The Human Tissue Act 2004 (and subsequent amendments) covers England, Wales and Northern Ireland.
As a result of the Act, the Human Tissue Authority (HTA) was established to regulate activities concerning the removal, storage, use and disposal of human tissue. The HTA also licenses organisations that store human tissue for research activity. Consent is the fundamental principle of the legislation.
Retention of tissue after project completion
Brighton & Sussex Medical School (BSMS) holds an HTA licence which allows researchers to store human material collected for a defined (and Ethics approved) project for future unspecified research once the original project has been completed – this licence extends to researchers at UHSx. The facility is only available on application and is subject to review by the BSMS Tissue Bank Committee.
All work at UHSussex that comes under an HTA licence must conform to Trust standard operating procedures.
Samples not accepted into the BSMS Tissue Bank will be required to be destroyed or transferred to another HTA licensed facility. Accepted samples will be subject to certain conditions detailed by BSMS. Researchers wishing to retain tissue for future unspecified research should amend their participant consent forms accordingly and include this information in their initial Research Ethics application.
Use of banked samples for projects will be subject to application and approval by the BSMS Tissue Bank Committee.
For further information, please visit the BSMS HTA website.
Further information about research
The HRA has produced a wide range of training resources, including slides, checklists, flowcharts, leaflets and e-learning modules.