Regulatory requirements and approvals

Further information about sponsorship can be found on the sponsorship page.

Most research conducted at BSUH will require an independent Research Ethics Committee (REC) opinion provided through the Health Research Authority’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 here.

Studies exempt from REC review may still require ethics review by a Higher Education Institution. 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 visit http://www.hra.nhs.uk/research-community/applying-for-approvals/hra-approval/.

Please remember to inform bsuh.rd.approvals@nhs.net of your intent to apply for HRA Approval, so that we are aware of your plans. You can also use this email address if you have any queries that the HRA guidance does not answer.

Please note that if you would like your project to be considered for NIHR Clinical Research Network (CRN) support and inclusion on the NIHR CRN Portfolio, you must submit a Portfolio Application Form (PAF) before your IRAS application form.  The PAF is listed in the Project Forms in IRAS if you answer ‘Yes’ to Question 5b of the Project Filter questions.

Alongside seeking HRA Approval, researchers / 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 that:

• 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 (bsuh.rd.approvals@nhs.net), before the HRA Approval application is made, so that we can begin to assess our capacity and capability to support you. It is vital that the R&D office 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 BSUH 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.

The Human Tissue Act 2004 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 facility is only available on application and is subject to review by the BSMS Tissue Bank Committee (Chair: Kevin Davies).

All work at BSUH that comes under the HTA must conform to BSMS SOPs. The tissue is collected at BSUH, but stored at BSMS for the future.

Samples not accepted into the Bank will be required to be destroyed or transferred to another HTA licensed facility. Samples accepted into the Bank will be subject to certain conditions detailed by BSMS. Researchers wishing to retain tissue for future unspecified research should amend their Consent Forms accordingly and include this information in their initial 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 click here to visit the BSMS HTA webpage.