04.01.22 - Combined Review The only way to apply for new clinical trials of investigational medicinal products (CTIMPs) or combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials).
04.01.22 - Automatic registration of clinical trials: all studies submitted through combined review on or after after 1 January will be automatically registered with ISRCTN registry when given approval. Read the news story.
27.05.21 - New eligibility criteria for the review of student research from 1 September 2021. Applying across the UK to ensure students gain the best learning experience of health and social care research.
24.03.21 - Changes to UK amendment process. For more information please see the HRA bulletin.
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.
|The University will adopt the role of Sponsor when:|
|- work is undertaken by a Principal Investigator who is a University of Bath employee|
|- the University of Bath registered doctoral student is acting as Chief 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 research or placement is not considered 'research' according to the UK Policy Framework for Health and Social Care Research, unless advised to the contrary, and therefore will not require a sponsor. If you are unsure whether your project is considered as 'research' according to the Framework please use the decision tool to help you decided where or not your study is research.
|If you require information about ethical consideration for undergraduate research and/or student placements please contact your Faculty Research Governance Coordinator.|
Where it is proposed that the University acts as a Sponsor you must follow the agreed protocol which to meet the DoH and NRES' requirements. Each application to the University, is considered on a case by case basis. Application forms must be submitted by the PI or supervisor of a Doctoral student.
Sponsorship Application Protocol
Sponsorship should be sought well in advance of the start of the project. 2-3 months prior to the start date is recommended to allow enough time for NHS approvals. No project can be initiated until approval is received.
The Principal Investigator (PI) (or in the case where a doctoral student is the Chief Investigator (CI), the Academic Supervisor) is responsible for providing all relevant information, including the monitoring and reporting arrangements to be undertaken. Having considered the requirements of the Sponsor's role, the PI/Academic Supervisor is required to complete a Sponsorship Application Form details below where they confirm that the information provided is accurate as well as assuming responsibility for compliance with the Policy Framework and with all University policies.
The PI (or in the case where a doctoral student is the CI, the Academic Supervisor) will then present the form to their Head of Department (HoD) for countersignature. The form should be supported by the HoD or appropriate representative prior to it being submitted by the Faculty Research Governance Framework Coordinator (FRGC).
Once the FRGC has checked the forms, they will forward all documents to firstname.lastname@example.org for processing by VCO. All received document sets will be sent to a member of the 'Sponsorship Risk Management Group' who will make a recommendation to the Pro-Vice-Chancellor (Research) (PVC-R).
If the University agrees to offer Sponsorship Approval, a letter will be issued and the Organisation Information Document (s) authorised. This letter will form part of your study document pack.
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.
If you are conducting a Clinical Trial of an Investigational Medicinal Product (i.e. trying out a new drug, or using an existing drug for new things) or testing an innovative surgical technique you will also need to apply to the MHRA.
|Before starting your research please ensure that all correspondence and approvals from the NHS REC, HRA&HCRW and MHRA (if applicable) are forward to the VCO. Please note that no study can commence until the VCO receives and acknowledges these documents.|
Please read our section on Continued Project Governance for important information on regarding the mandatory conditions of the ethical approvals, information about amendments, and other useful guidance.
If the University is content to offer Sponsorship, a Letter of Sponsorship will be issued. This letter will form part of your study document pack. The PI would need to upload this letter to IRAS and request elctronic authorisation from the PVC-R using email@example.com.
If you are conducting Clinical Trial of an Investigational Medicinal Product (i.e. trying out a new drug, or using an existing drug for new things) or testing an innovative surgical technique, then you will need to obtain MHRA approval.
Research involving NHS resources in England and Wales requires HRA and HCRW (Health and Care Research Wales) approval. More information can be found on the IRAS website. The application for HRA and HCRW review is completed via IRAS.
All applicants for university sponsorship should provide the following documents:
CRA1 form (Sponsorship Application for Research Projects (not clinical trials) Or CTA1 form (Sponsorship Application for Clinical Trials involving drugs or surgery, if the project is a clinical trial) which can be found on our website
Ethical Implications Research Assessment 1 Form (EIRA1) Please note: the electronic EIRA form needs to be electronically authorised by the second reader and HoD before you download and submit it with your sponsorship application. If you have any queries about this process, please contact your Faculty Research Governance Framework Coordinator
IRAS Form (for HRA&HCRW Approval and REC Favorable Opinion (if required). Register at https://www.myresearchproject.org.uk
A summary (max 1/2 page) of your research, suitable for a lay audience
Local Information Pack - please check the HRA website for details of contents and templates.
Patient Information Sheet (PIS) - using the HRA template
Informed Consent Form - using the HRA template
Protocol - using the HRA guidance
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.
|Additional Forms To Be Completed During the Pandemic:|
|These forms are designed to be completed by Researchers (staff or students) who are:|
restarting projects currently under Sponsorship which have been paused due to the pandemic
starting projects already under Sponsorship which were not able to be started due to the pandemic
applying for Sponsorship of new projects which will start during the pandemic
Preparing New Projects in IRAS
A step by step guide for seeking HRA and HCRW approval can be found on here.
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 this project is the Pro Vice-Chancellor (Research) The PVC-R will receive copies of all correspondence from REC and HRA/R&D reviewers that is sent to the CI. Please use firstname.lastname@example.org 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.
• 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 completed by the VCO once the OID is approved.
• If you require an OID, PIC or any other agreement after Sponsorship has been issued please follow the guidance below.
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 HRA.
Continued Project Governance
Monitoring and Auditing
If your study is identified as requiring annual monitoring and audit, you will be informed that sponsorship is conditional to the study being monitored annually, and you will be asked if you are happy to proceed with it on that basis.
Once confirmed, you will be sent a request once a year asking you to complete an annual monitoring report. The PA to the PVC-R will also contact you with an audit form to check that paperwork relating to the study is in order. Both forms are available from our website.
PICs and OIDs and other Agreements
If a PIC Agreement 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 PIC or mNCA – return the signed agreement to the Sponsor office so that the agreement can be checked and signed by the Sponsor. 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 REC approval is issued, and the participating organisation/s have signed the OID please email the signed copy/copies to the Sponsor Office for their records. Please ensure that all documents are completed using track changes and the most up to date templates from HRA.
Annual and Final Reports
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.
Amendments to a study
Amendments are changes made to research projects after review body(ies) approval has been given (and sometimes during the approval process itself) and can be classified as either substantial or non-substantial.
To make an amendment to your research project, you need to complete the amendment tool on the IRAS website .
Once the amendment tool is completed, you must submit it together with all relevant supporting information to your FRGC for an initial review. The paperwork will then be forwarded to the PA to the PVC-R for review by the Risk Assessment Panel. The panel will make a recommendation to the sponsor on whether or not the amendment should receive Sponsor sign off. As the ammendment tool automatically categorises the type of ammendment(s) you will no longer receive this information as a separate notification.
Please include: - a summary of the changes - completed amendment tool
The PA to the PVC-R will authorise and lock the amemdment tool and send a pdf copy to you. You can proceed with submission of the amendment following the guidance on IRAS.
For information on what happens once you submitted your amendment please here.
Implementation of Amendments
Upon submission of either a Non-Substantial or Non-Substantial, No Study-wide Review amendment, you will receive a system generated confirmation email. You should then follow the guidance in the amendment tool on how to communicate the amendment to the participating site(s) as this will vary depending on where the sites are located and the categorisation of the amendment (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 Amendment Tool with confirmation of amendment category and, if applicable, amended documents with relevant participating NHS organisations in England and/or Wales. In doing so, you should include the NHS R&D Office, LCRN (where applicable) as well as the local research team and the VCO.
For further guidance on how to implement amendments please check the IRAS website.
Changes to UK amendments were announced by HRA in March 2021. This guidance has been updated accordingly.
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 PI or their nominee (responsibility lies with the PI/CI) to the Sponsor within 24 hours of their taking place (an initial report, further details can be provided when these are available).
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 Project Manager (University Research), in the first instance.
If you need to report a minor breach of the protocol please contact email@example.com 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, fraude 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
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 firstname.lastname@example.org at least 3 months before leaving so that appropriate arrangements are made regarding your study and associated Sponsorship.
Example answers to insurance/indemnity questions on IRAS
Please copy and paste responses into the form as appropriate. Refer any queries to email@example.com
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 Batth 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.
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,