A sponsor is the organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project.

When seeking approval to undertake a research project, the documentation and information required will depend on whether the study sponsor is Aston or if the study sponsor is a third party organisation (e.g. an NHS Trust or another University).

Guidance on what is needed in both cases can be found in the sections below. If you are unsure who is sponsoring your study, please email the Research Integrity Office.

Background information and work involving the NHS

All health and social care research requiring collaboration with the NHS should have a Sponsor. The Sponsor takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project under the UK Policy Framework for Health and Social Care Research. The Sponsor also takes ultimate responsibility for the management of the research. The Sponsor must be made aware of any and all changes in relation to a research project once sponsorship is confirmed. If you wish to name Aston University as the Sponsor of your research project you must follow the guidance below.

Here are the responsibilities if you are the CI of a piece of research.

Where Aston University is not the study sponsor but Aston is a research site then a Governance Review must be undertaken and details of how to obtain approval is given below.

Examples of this type of scenario are:

  • Aston has been asked to identify healthy participants for an ongoing interview study which has NHS ethics and where another University is the sponsor.
  • Aston has been asked to recruit participants for an ongoing contact lens clinical trial which hasNHS REC and HRA approval and where a commercial company is the sponsor.

Whether or not Aston is to sponsor a study, you are encouraged to liaise with AURIO as early as possible in the process. Please email research governance.

Aston University is study Sponsor

The following minimum document set is to be sent as a zip file to the Research Integrity Office via email. If you have a large number of documents and/or wish to share via Box, please email AURIO to facilitate.

  • Complete the HRA decision tools (“Is my project research?” and “Do I need a REC review?”) and save as PDF*)
  • Completed IRAS form as PDF;
  • Study protocol;
  • All participant facing documents e.g. participant information sheet and consent forms (using current templates) and any study measures;
  • Risk assessment;
  • Draft delegation of duties document for each research site.

* If the tools determine that you do not need NHS REC approval (or does not meet their definition of research), you may still require ethics approval from Aston University and you should contact AURIO.

Aston University not the study sponsor

The following minimum document set is to be sent as a zip file to the Research Integrity Office via email. If you have a large number of documents and/or wish to share via Box, please email AURIO to facilitate.

  • Letter of favourable ethical opinion from an NHS REC (if applicable)
  • Letter of Health Research Authority approval (if applicable)
  • Confirmation of any amendments which add Aston as a research site (if not named on IRAS form)
  • Study protocol including work to be undertaken at Aston
  • Copies of any participant facing documents to be used at Aston
  • Delegation of Duties Log for all Aston staff and CVs of all staff listed.
  • Sponsor indemnity or insurance document
  • Draft site agreement for use between Aston and the sponsor
Key information when completing an IRAS submission

The IRAS Form

Complete an IRAS form leaving no questions blank. Guidance is provided within the IRAS system regarding completing your application, but if Aston University is to be named as Sponsor you will need to include the following information:

A3-1 Chief Investigator:

According to section 9.3 of the UK Policy Framework for Health and Social Care Research, students should not normally take the role of Chief Investigator at any level of study, as this function should be undertaken by supervisors or course leaders. Exception is made for an experienced care practitioner or manager undertaking an educational qualification for continuing professional development or doctoral-level study while employed by a health and social care provider or university, or for a researcher undertaking a doctoral-level study in receipt of a fellowship.

Normally the student’s academic supervisor should be named as the Chief Investigator and should complete both the CI and supervisor declarations in Part D.

A4: sponsor contact details for correspondence are:

Matthew Richards

Research Integrity Office

Aston University, Birmingham B47ET

Tel: 0121 204 5069

Email: Research Governance

A64: Sponsor Status: Academic

Contact person: Rebecca Stokes

Research Integrity Office,

Aston University,

Birmingham, B4 7ET

Email: Rebecca Stokes

Tel: 0121 204 3099

A76-1 Management -“Other insurance or indemnity arrangements will apply” - Aston Insurance will apply

A76-2 Design -“Other insurance or indemnity arrangements will apply” - Aston Insurance will apply

A76-3 Conduct –Tick both options if research undertaken at both NHS and non-NHS sites and give details.

A78 – tick yes if you are sure new IP will be generated (if your work could lead to the development of a new product or if you are producing anything other than scholarly works).

Student research

Student applicants must answer yes to Question 9. If it is a student project, as above, the student must not be listed as the CI other than in exceptional circumstances.Note that the eligibility criteria for student research was updated from 1 September 2021 and that some non-doctoral level student projects (i.e. Undergraduate and Master’s level) may not be eligible for NHS REC review. PhD students are not affected. Please ensure you read the latest guidance or contact the Research Integrity team.

Participant facing documents

Please ensure that the latest Aston University templates are used. If your study involves the NHS, you may require their GDPR Transparency wording which can be obtained from the HRA website.

For the the latest Aston University templates please see the Ethics section of our webpages.

Insurance

If Aston University are to sponsor the study, please ensure you have checked the University Insurance website and can confirm that your study is covered.

Schedule of Events Cost Attribution Template (SoECAT) guidance

If you need to complete a SoECAT please see the guidance document below:

The validation process and approval timeline

Aston Sponsoring

The process for review and validation of an IRAS submission where Aston is sponsor is as follows:

Submission to AURIO

If any of the key documents listed above are missing or incomplete, you will be contacted to provide these (please note that this may delay the review process).

Application checked and validated

Upon receipt of your key documents, AURIO will undertake a validation check to ensure that the required information and documentation required has been provided.

Upon completion of the review, you will be provided with feedback in the form of an annotated document set and/or a separate document detailing the points that need to be addressed before we can either agree to sponsor the study or to be a site on a non-Aston sponsored project.

You may be asked to provide updated and/or additional documents showing tracked changes which address any points raised. These points will then be further reviewed and any further clarifications sought prior to submission.

Sponsorship confirmed in principle

When your application is confirmed as valid for review, you will be issued with an “in principle” letter for upload to IRAS along with your submission.

At this point, AURIO will make arrangements to contact any named NHS sites listed on your IRAS form to formally notify them of the research and provide them with a “Local Information Pack”.

NHS REC review

After validation of your application in IRAS, you will be required to book your application in for an ethical review. Guidance to do this is available in IRAS.

After REC review, you may be asked to provide further information or amended documents prior to favourable opinion being issued. AURIO will support you with your response to the REC.

Subject to satisfactory provision of any outstanding documents or clarifications, you will receive a confirmation of favourable ethical opinion. Please read this letter carefully as it outlines any conditions of approval, next steps and your obligations.

HRA approval

If your project involves the NHS, an HRA review will be undertaken in parallel with the REC review (unless your research involves NHS staff only, in which case, only an HRA review will be undertaken).

Please note, even when you receive confirmation of HRA approval you cannot begin to undertake research within the NHS until NHS organisations have confirmed their capacity and capability to host the research.

NHS Capacity and Capability

Upon receipt of HRA approval (and/or NHS REC favourable opinion), AURIO will contact those NHS research sites listed in Part C of your IRAS to request formal confirmation of capacity and capability and provide a final “Local Information Pack” which includes the final clean versions of all study documents and localised Organisation Information Document and Schedule of Events.

When you have receipt of C&C from a Trust, you will be issued with a formal confirmation of sponsorship (also known as our “Green Light”) which will allow the research to commence.

Please note, you must only begin working with NHS sites when they have confirmed C&C with Aston and you have been issued with a letter of sponsor approval listing that site. Failure to obtain appropriate approval is a breach and will be reported to the HRA and your study may be suspended until the issue is resolved.

If you wish to add sites not listed on your IRAS form, you must submit an amendment to add them. Again, please do not begin any research activity at a site until the amendment has been approved and C&C has been received from the relevant Trust.

Changes made without sponsor knowledge can cause sponsor to suspend the study. Under no circumstances must any amendment be submitted to the HRA without sponsor approval. Guidance for completing substantial and non-substantial amendments. Examples of each can be found here, but it is ultimately the Sponsor who determines the category of amendment. https://www.hra.nhs.uk/approvals-amendments/amending-approval/-state here who you send those documents to and what happens next.

NHS Research Passports

Any researcher, whether staff or student who is conducting research in the NHS and who does not already have a contract with the NHS will need either a Letter of Access (LoA) or Honorary Research Contract.

If you think you need a research passport, please e-mail AURIO with the following details:

  • Project details including whether ethics approval has been obtained
  • Supervisor details (if applicable)

LoAs or Honorary Contracts are obtained via the Research Passport process, details of which can be found on the HRA’s website.

The process requires completion of the following document set.

  • Research passport application
  • Current CV (on HRA 2-page template)
  • Evidence of Good Clinical Practice Training
  • DBS Check
  • Occupational health screening
  • Evidence of Hepatitis B immunity (if working with human tissue)

Aston staff: Please contact the HR Business Partner for your College and they will assist in the completion of this document and support you with obtaining any required health screening.

Aston students: Please email research governance and the AURIO team will support you through the process.