NEWS

New Clinical Trial Regulations come into force from 28 April 2026

Open House session Working with the NHS sponsorship and IRAS process This Open House presentation provides helpful guidance.

Important information for Master's Students If you are a Master's student requiring Sponsorship to carry out a research project please see HRA guidance and associated toolkit to ensure you are eligible before contacting nhs-sponsorship@bath.ac.uk so that we can guide you through the application process.

Background

All research in health and social care that involve NHS patients, their tissue or information, staff, equipment or other resources of the NHS that might have an impact on the quality of health or social care services requires a formal research Sponsor. This is a fundamental requirement for all research falling within the remit of the Secretary of State for Health.

Sponsorship is also required for any project involving the storage of human tissue (as defined under the Human Tissue Act 2004 ). The University of Bath does not hold a Human Tissue Licence and as such all work with human tissue will require formal NHS Research Ethics Committee (NHS REC) approval even if the project does not involve NHS patients.

The Sponsor of a research project is the organisation that takes formal responsibility for the initiation, management and financing of the research. For more information on roles and responsibilities please see the HRA website.

Eligibility criteria

The University will adopt the role of Sponsor when:

• work is undertaken by a Chief Investigator who is a University of Bath employee
• the University of Bath registered doctoral student is acting as Principal Investigator and the supervisor is a University of Bath employee

The University will not normally adopt the role of Sponsor for any other projects.

• Undergraduate level: Health and social care research applications from students working at undergraduate level are no longer being accepted for Research Ethics Committee (REC) review; HRA and HCRW Approval; and/or Research and Development (R&D) study-wide review in Scotland and Northern Ireland.
• Master's level: Applicants should complete the student research toolkit in the first instance, to check eligibility. Some health and social care research applications from students working at Master's level are no longer being accepted for Research Ethics Committee (REC) review; Health Research Authority and Health and Care Research Wales (HRA and HCRW) Approval; and/or R&D study-wide review in Scotland and Northern Ireland.
• Doctorate level: Applicants are eligible to complete health and social care research, subject to relevant approvals being in place. Applicants may find it useful to complete two parts of the toolkit to understand if HRA and HCRW Approval (or equivalent in Northern Ireland and Scotland) and/or NHS Research ethics review is required.

If you are unsure whether your project is considered as 'research' according to the Framework please use the HRA decision tool and HRA defining research table to help you decide whether or not your study is research. The NHS REC decision tool will help determine if you require NHS research ethics review. For more information on this topic please see our FAQ

Each application to the University, is considered on a case-by-case basis.

Sponsorship Application Protocol

Sponsorship should be sought well in advance of the start of the project. We recommend you apply 2-3 months prior to the start date to allow enough time for NHS approvals. No project can be initiated until approval is received.

As of 3 April 2023 applications for Sponsorship should be made by the Principal Investigator, using Ethics@Bath, the University's ethics online system, which can be accessed here. You will need to use your University email address (e.g. ab123@bath.ac.uk) and password to log in.

In line with the UK Policy Framework for Health and Social Care Research and applicable legislation the Principal Investigator (PI) is an individual responsible for the conduct of the research at a research site. There should be one PI for each research site. In the case of a single-site study, the Chief Investigator (CI) and the PI will normally be the same person. For student research that falls under this Framework, students take the role of PI and Academic Supervisors take the role of CI.

Prior to final sign off the application will be reviewed by a member of the External & Sponsorship Ethics Committee. Once reviewed, comments will be provided to the Chair of this Committee who will advise whether the University should sponsor the application.

If the University agrees to offer Sponsorship Approval, a letter will be issued via Ethics@Bath. This letter will form part of your study document pack. The PI/CI will need to upload this letter, along with any supporting documents, to IRAS and request electronic authorisation from the Associate Pro Vice Chancellor-Research (APVC-R) using pro-vc-research@bath.ac.uk.

Research involving NHS resources in England and Wales requires HRA (Health Research Authority) and HCRW (Health and Care Research Wales) approval. The application for HRA and HCRW review is completed via IRAS. Please read the 'Preparing New Projects in IRAS' section for more information.

On submission of the study within IRAS, if NHS REC review is also required you will need to book the meeting date online on the same day. You will be asked a series of questions to determine which Research Ethics Committees (RECs) are suitable, dependent on the study type. Some studies must be reviewed by a REC that is ‘flagged’ for the type of research which is to take place. More information on booking the REC is available here.

If you are conducting a Clinical Trial of an Investigational Medicinal Product CTIMP (e.g. trying out a new drug, using an existing drug for new things) or an investigational medical device/in vitro diagnostic (IVD) device (e.g. testing an innovative surgical technique or medical device software app) you will also need to apply to the MHRA. This review takes place at the same time as HRA and HCRW and/or NHS REC review. Please see further guidance under CTIMP and Medical Device studies.

Following submission in IRAS, initial checks are done and a validation letter issued before the study proceeds to HRA & HCRW and/or NHS REC review. Applicants to an NHS REC will be invited to virtually attend the meeting. The REC will issue their opinion following the meeting. For combined review (CTIMPS/medical devices) the MHRA and NHS REC review occurs in parallel so a joint letter is issued (refer to the following guidance for more information and timelines). The HRA & HCRW assessment also occurs at the same time, but final approval is issued once all other regulatory approvals have been received and a REC final opinion issued. Please see further information HRA Approval and The approvals process for non-CTIMPs - Health Research Authority for timelines.

Please read our section on Continued Project Governance for important information on regarding the mandatory conditions of the ethical approvals, information about amendments/modifications, and other useful guidance.

Forms Required

You will be guided through the application process on the ethics online system. For guidance on completing a sponsorship application click here. You will also need to attach the forms below to your application on Ethics@Bath.

1. IRAS Form (for HRA&HCRW Approval and REC Favourable Opinion (if required). Register at https://www.myresearchproject.org.uk

2. Full CVs for all applicants (staff and students)

3. Sponsorship Risk Assessment Form

4. Local Information Pack which needs to include an Organisation Information Document, Schedule of Events (SoE) or Schedule of Events Cost Attribution Template (SoECAT); applicable model agreements (e.g mNCA, mMPICA, mNCA) and delegation log if appropriate. Please check the IRAS website for details of contents and templates. Guidance on how to complete the SoECAT is available here.

5. Copy of two independent peer reviews/scientific critiques or evidence that the proposed study has been peer reviewed and all comments incorporated into the study.

6. Patient Information Sheet (PIS) - using the HRA template

7. Informed Consent Form - using the HRA template

8. Protocol - using the HRA guidance

9. For projects involving human tissue samples please provide copy of the MRC e-learning certificate on ‘Research and human tissue legislation assessment – England, Wales and Northern Ireland”. This is a training requirement for all staff working with human tissue. The MRC e-learning module can be accessed here. For more information please see Training Requirements for Human Tissue Act 2004.

10. For projects working with human tissue samples defined as Relevant Material by the Human Tissue Act a Human Tissue Risk Assessment Form must be completed. For further information please see Working with Human Tissue at the University.

11. For CTIMPS/medical devices – MHRA documentation (covering letter, investigational medical product (IMP) dossier, labelling content of IMP, manufacturer’s authorisation - See Documents to send with your application along with the annotated checklists indicating MHRA review required (see section CTIMP and Medical Device studies).

Preparing New Projects in IRAS

New users to IRAS should consult the online guide. For CTIMPs and combination trials of an investigational medicinal product and an investigational medical device (IMP/Device) this IRAS guidance is applicable. This guide to using IRAS to apply to conduct research in or through the NHS/HSC provides step by step information on the whole process.

There are a number of errors that are often seen in applications for HRA and HCRW Approval. These usually delay the progress of an application and in some instances may lead to the application being rejected. Please see this page with some tips to avoid some of the common application errors.

The contact, on behalf of the sponsor, for all correspondence relating to applications for projects is the Associate Pro-Vice-Chancellor (Research) , Professor Rachel Arnold. The APVC-R will receive copies of all correspondence from the NHS REC and HRA/R&D reviewers that is sent to the CI. Please use nhs-sponsorship@bath.ac.uk for all communication.

Organisation Information Documents - information to note

The outline OID (Organisation Information Document) should give information that will be common to all participating NHS/HSC organisations undertaking the same activities within the study. In some studies, some NHS/HSC organisations will undertake different activities to others. In this scenario you will need to create and submit an outline OID for each group of NHS/HSC organisation undertaking the same activities.

The outline OID(s) must be electronically submitted as part of the IRAS Form application. This means you must attach the outline OID(s) to the IRAS Form checklist prior to e-submission of the application. Furthermore, the OID(s) need to be submitted to the Sponsor, for approval, when Sponsorship is requested.

The OID can also act as the agreement between the Sponsor and participating organisations in place of any other form of site agreement/contract.

NOTES:

• Where the OID asks for ‘Contact details of sponsor, or sponsor’s delegated point of contact for questions relating to study set-up’,(Q4), this should be a researcher involved in the study, not the PVC-R.

• Where the OID asks for ‘Authorised on behalf of the Sponsor’ (Q18) this will be fully by the Sponsor once the project has been approved by the REC.

• If you require an OID, PIC or any other agreement after Sponsorship has been issued please follow the guidance below.

GDPR advice

The HRA has produced GDPR guidance for researchers and study coordinators.

The HRA has produced recommended wording to fulfil transparency requirements under the GDPR for health and care research that can be included in the PIS or provided as a separate document.

Other templates to help with GDPR compliance are also available from the HRA.

Registration

To promote transparency within research, all studies need to register on a public registry before the first participant is recruited or within 90 days of approval - whichever is earlier. This is a legal requirement for CTIMPs. The ISRCTN is the preferred registry, unless the U.S. Food and Drug Administration (FDA) is involved and then registration with ClinicalTrials.gov is required. The ISRCTN charge £250+VAT for registration. For non-CTIMP studies other public registries can be considered (e.g. Research Registry).

Both ISRCTN and ClinicalTrials.gov also feed into Be Part of Research, an online service run by the NIHR to inform the public and help recruit to studies. To be eligible for the service, the study must be funded or supported by the NIHR and have REC approval. More information is available on Eligibility for NIHR Research Delivery Network support | NIHR.

Working with the Ministry of Defence or His Majesty’s Prison and Probation Services

If your research involves human participants and is funded by the Ministry of Defence (MOD) and/or involves MOD personnel and/or MOD entitled dependents, you will require Sponsorship from the University. Please follow the guidance here.

Research with staff and/or offenders in prisons, the probation service, or within His Majesty’s Prison and Probation Services (HMPPS) will require Sponsorship if approval from health and social care bodies is required too. Please follow the guidance here. If no health and social care body is involved, then Sponsorship is not required and you can proceed with submission to the HMPPS National Research Committee (NRC) as detailed in the guidance. Note, the NRC is not an ethics committee so you will need to seek an appropriate ethics review as well (e.g. University ethics committee).

Continued Project Governance

Monitoring and Auditing

If your study is identified as requiring monitoring and/or audit, you will be informed that sponsorship is conditional to the study being monitored, and you will be asked if you are happy to proceed with it on that basis.

Once confirmed, you will be sent a request asking you to complete an audit and monitoring report by the Research Policy, Governance and Integrity Team.

PICs, OIDs and other Agreements

If a PIC Agreement (mNC-PICA) or a model Non-Commercial Agreement (mNCA) was submitted this will be reviewed as part of the Sponsorship Approval process. Once HRA and/or REC approval is issued, and the participating organisation/s have signed the mNC-PICA or mNCA – return the signed agreement to the Sponsor office highlighting if any changes have been made by the site before the Sponsor signs the agreement. The signed copy should then be sent to each participating organisation by the Chief Investigator or one of their representatives.

If an OID was submitted, once HRA and/or NHS REC approval is issued, and the participating organisation/s have signed the OID please email the signed copy/copies to the Sponsor Office for completion. Please ensure that all documents are completed using track changes and are the most up to date templates from the HRA.

Annual and Final Reports

A final report should be submitted to the REC within 12 months of the end of the study. If you submitted via combined review, you should complete and submit the final report form in IRAS. All other studies need to use this webform.

For CTIMP/medical device studies you do not need to submit a summary report to the MHRA as well, but instead send a short confirmatory email to CT.Submission@mhra.gov.uk after updating the public register. If the trial is not on a public register, summary results should be submitted via MHRA Submissions (contact the Sponsor office for details). This must be completed within one year of the end of the trial. Further information is available on the MHRA website under Clinical trial summary results.

The PI/CI named on the Sponsor letter should ensure that copies of all reports (e.g. annual and/or final) sent to the NHS are forwarded to the VCO for their records.

End of Study

For all non-CTIMP studies, the end of study declaration form should be completed and emailed to the REC within 90 days of the end date.

For studies with both a REC favourable opinion and HRA and HCRW approval, you only need to declare the end of study to the REC, as described above.

For studies that have HRA and HCRW approval, but did not require REC review, you need to notify the HRA directly when the study has ended by emailing [approvals@hra.nhs.uk])(mailto:approvals@hra.nhs.uk) (include IRAS ID and contact information -phone and email). For more information refer to Ending your project - Health Research Authority.

For CTIMPs/medical device studies the same end of trial form is used to notify both the REC and MHRA. If the study was originally submitted through combined review the end of trial form should be submitted in IRAS, otherwise complete a declaration of end of a clinical trial and email this to the MHRA and REC within 90 days of the end of trial. The submission must include an end-of-trial form and a covering letter. It is the manufacturers responsibility to email the MHRA when a clinical investigation of a medical device comes to an end. More information is available on the MHRA website under End of trial.

Informing participants

Where applicable, people who have taken part in a research project should be thanked for their contribution and informed what it helped reveal. See the HRA guidance on writing a plain language (lay) summary of your research findings and communicating study findings and communicating study findings to participants.

Publishing results

Research findings, whether positive, negative, neutral, or inconclusive should be made accessible when the study ends. Where the main findings are to be submitted for publication in a journal, this should be done within 12 months of the end of study and should be published through an open-access mechanism in a peer-reviewed journal.

Samples and data management

If your study involved human tissue at the end of the study (in line with the protocol and terms of the consent from the donors) you may have agreed to dispose of the human tissue or transfer the tissue to a licensed establishment. You should also ensure any research data and personal data is stored or destroyed appropriately, as detailed in your protocol and in line with GDPR and the Data Protection Act.

CTIMP and Medical Device studies

All Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials) need to apply using the combined review service, which can be accessed using the new part of IRAS. Combined review means the MHRA and NHS REC review are done in parallel, so a single decision is issued. The study also goes for study wide review (HRA and HCRW review) which is usually issued around the same time or a little later. Please use the guidance on the HRA website for instructions on how to apply for combined review.

To determine if your study meets the definition of a clinical trial or medical device that requires submission to the MHRA you can check the following charts:

• Is it a clinical trial of a medicinal product requiring MHRA review?
• Is it a medical device requiring MHRA review?
• Is it medical device software/app requiring MHRA review?

Please annotate these charts to indicate and submit them as pdf documents with your Ethics@Bath form.

All applications to run a clinical trial of an investigational medicinal product (CTIMP) must go through the combined review service. The initial combined review assessment is completed within 30 days of submission. If the MHRA request additional information you have 14 days within which to respond otherwise the application will be rejected. See more information under Submit your clinical trial application and Common issues identified during clinical trial applications - GOV.UK.

For Phase 4 and some Phase 3 clinical trials deemed to be of lower risk, application via the MHRA’s Notification scheme enables a faster approach (processed within 14 days, rather than 30). For more information refer to the MHRA Notification scheme.

Note: The MHRA fees related to submission of CTIMP/medical device studies Current MHRA fees - GOV.UK along with costs associated with amendments, reports etc. These costs will need to be factored into the funding application.

Amendments to a study

Amendments are changes made to research projects once a favourable opinion has been issued. For details about definitions of amendments to research projects in general terms please see our guidance page on 'Amendments Process'.

Projects under sponsorship, have an extra set of requirements to ensure that due diligence is carried out with the HRA and/or NHS REC. From 28 April 2026, the HRA have issued new terms and categorisations for amendments, now known as ‘modifications’. In addition to our internal definition of amendments, these modifications are further classified as either substantial, substantial, modification of an important detail or minor modification.

Researchers wishing to amend a previously reviewed project will need to submit an amendment request via Ethics@Bath. For step-by-step guidance on how to submit an amendment via Ethics@Bath, please see here. In addition, researchers will need to complete the modification tool on the IRAS website . This guidance applies to projects processed through Ethics@Bath but also to 'legacy projects' reviewed before Ethics@Bath was launched.

Instructions on how to prepare a modification and how to use the modification tool can be found here. The current version of the modification tool can be accessed via this link. Please ensure you unlock the tool on downloading it so all boxes can be edited (right click on the downloaded file, select ‘Properties’, tick the 'Unblock' box and click 'Apply', ‘OK’). Leave rows 8 and 9 blank (Sponsor reference and date), select ‘Yes’ for row 78 (the University is a non-NHS site) and leave Section 3 for sponsor to sign and lock. To add new NHS research sites/Patient Identification Centres (PICs), a separate modification is recommended to any other changes you’re making to the study. This lets the set-up of those sites/PICs happen while other modifications are being reviewed separately so they can be set up sooner. Please see further guidance on IRAS under 2. Modifications to add new NHS/HSC sites or PICs when adding new NHS organisations.

Once the modification tool is filled, you must submit it together with all relevant supporting information for review via the Ethics@Bath system.

When submitting your request for an modification via Ethics@Bath please include the following documents with your amendment form:

• completed modification tool, unsigned and unlocked
• updated versions of all project related materials (e.g. protocol, participant facing materials etc as applicable) with the revisions shown as tracked changes

The Secretary to the Committee will then progress the review process and will seek Sponsor signature and lock the modification tool before returning it to you via email as a PDF file. You can proceed with submission of the modification following the guidance on IRAS.

Implementation of Modifications

Modifications must not be submitted without prior authorisation from or on behalf of the sponsor. The modification tool will tell you the modification's category based on how you complete it. A modification category is separate from whether it is  substantial, a modification of an important detail or minor modification. The category confirms whether the modification has delivery implications for all, some, or none of the participating organisations. It tells participating organisations to check whether they need to do anything to implement the modification. There are 3 categories: A, B, and C (see table on IRAS website).  

Upon submission of the modification, you will receive a system generated confirmation email. For modifications that require regulatory review (e.g. HRA) you must wait to receive an approval email before implementing the modification. Note: modifications of an important detail and minor modifications do not require a REC review outcome. Further information is available on the NIHR and HRA websites.

You should then follow the guidance in the modification tool and on IRAS (3. Sharing modifications with participating NHS/HSC organisations) on how to communicate the modification to the participating site(s) as this will vary depending on where the sites are located and the categorisation of the modification (A, B or C).

Once you have received the regulatory approvals (where applicable) or when you have completed the steps as per the guidance above the PI/CI is responsible for sharing the completed modification tool with amendment category and, if applicable, amended documents with relevant participating NHS organisations in England and/or Wales (4. Working with participating NHS/HSC organisations to implement modifications). In doing so, you should include the NHS R&D Office, RDN (where applicable) as well as the Research Policy, Governance and Integrity Team.

For further guidance on how to implement modifications please check the IRAS website.

Reporting any adverse events or other incidents

Any SAEs (serious adverse events) and any other incidents relating to sponsored projects should be reported by the CI or their nominee (responsibility lies with the PI/CI) to the Sponsor within 24 hours of their taking place. Further details can be provided when these are available. If the study has received NHS REC review SAEs should be emailed to the REC using the Non-CTIMP safety report to REC form within 15 days copying in Sponsor office (please refer to [Safety reporting - Health Research Authority])(https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/safety-reporting/)

Guidance and a reporting form for this are available here, giving information on responsibilities and other bodies incidents must be reported to.

Guidance and forms for reporting potential fraud or serious breaches of Good Clinical Practice (GCP) or the trial protocol of sponsored projects are available here.

If you need any advice in addition to the guidance documents, please contact the Research Policy, Governance and Integrity Team, in the first instance.

If you need to report a minor breach of the protocol please contact nhs-sponsorship@bath.ac.uk providing the following information:

• date and time of incident/breach
• date and time of being made aware of the incident/breach
• details of the incident e.g. data loss, fraud etc.
• what/who is affected. If a participant, their data or their carer's data is affected please include details of their ages and what measures you have taken to ensure that they are made aware of the data breach.
• any other relevant information

Staff Leavers

If you have University of Bath sponsorship for a study that is current, and you are planning on leaving the University, you must notify the Sponsor, by e-mailing nhs-sponsorship@bath.ac.uk at least 3 months before leaving so that appropriate arrangements are made regarding your study and associated Sponsorship.

Insurance Questions

Example answers to insurance/indemnity questions on IRAS

Please copy and paste responses into the form as appropriate. Refer any queries to insurance@bath.ac.uk

Only use these answers if University of Bath is the research sponsor and it is not a drugs trial

A76. Insurance/ indemnity to meet potential legal liabilities A76−1. What arrangements will be made for insurance and/or indemnity to meet the potential legal liability of the sponsor(s) for harm to participants arising from the management of the research?

Please tick: 'Other insurance or indemnity arrangements will apply' and add: ''The University of Bath has arranged Public Liability insurance to cover the legal liability of the University as Research Sponsor in the eventuality of harm to a research participant arising from management of the research by the University.''

This does not in any way affect an NHS Trust’s responsibility for any clinical negligence on the part of its staff (including the Trust’s responsibility for University of Bath employees acting in connection with their NHS honorary appointments).

Delete this 2nd paragraph if not applicable e.g. if your research takes place on University premises and/or involves no clinical intervention by the NHS.

A76−2. What arrangements will be made for insurance and/ or indemnity to meet the potential legal liability of the sponsor(s) or employer(s) for harm to participants arising from the design of the research?

If the University of Bath designed the research then tick 'Other insurance or indemnity arrangements will apply. and add: 'The University of Bath holds Professional Indemnity insurance to cover the legal liability of the University as Research Sponsor and/or as the employer of staff engaged in the research, for harm to participants arising from the design of the research, where the research protocol was designed by the University."

A76−3. What arrangements will be made for insurance and/ or indemnity to meet the potential legal liability of investigators/collaborators arising from harm to participants in the conduct of the research?

Tick the box 'Research includes non-NHS sites (give details of insurance/indemnity arrangements for these sites below)' and add: "The University of Bath’s Public Liability and Professional Indemnity insurance policies provide an indemnity to our employees for their potential liability for harm to participants during the conduct of the research. Again, this does not in any way affect an NHS Trust’s responsibility for any clinical negligence on the part of its staff (including the Trust’s responsibility for University of Bath employees acting in connection with their NHS honorary appointments)."

Delete this 2nd paragraph if not applicable e.g. if your research takes place on University premises and/or involves no clinical intervention by the NHS.

Option a) Use for clinical research within NHS Hospital Trusts. Add: Professor X/Doctor Y/Nurse Z/Student A also holds an honorary appointment with # NHS Hospital Trust giving him/her the protection of the NHS indemnity scheme.

*Option b) Use for clinical research outside an NHS Hospital Trust (including Primary Care). * Add: Professor X/Doctor Y has the protection of medical malpractice indemnity with MDU/MPS. (delete as applicable)

Option c) Use where there is a collaborating institution Add: The University of Bath’s insurance policies do not provide an indemnity to collaborators or Site Management Organisations (delete as applicable). As Research Sponsor we will ensure as far as reasonably practicable at the outset of the study that collaborators/SMOs (delete as applicable) hold appropriate legal liability insurance.

A76-4 What arrangements will be made for insurance and/or indemnity to meet any potential legal liability for harm to participants arising from any aspect of the research?

This question is rarely used. Refer to Simon Holt if you are required to give an answer. It will probably be a case of simply confirming existing insurance arrangements.

A77. Has the sponsor(s) made arrangements for payment of compensation in the event of harm to the research participants where no legal liability arises?

ALWAYS ANSWER “NO” TO THIS QUESTION – refer to Simon Holt circumstances require you to answer Yes.

Relevant Documents

Evidence of insurance cover is available to download from here

Any questions at all should be referred to : Simon Holt, Insurance Services Manager, Wessex House 4.22, 01225 385129

FAQs

Click here to view FAQs relating to sponsorship.