NEWS
In light of the launch of Ethics@Bath system, changes have been made to the Sponsorship process.
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.
HRA NEWS New quality standards for participant information materials published.
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 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 decision tool to help you decided where or not your study is research.
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 the Ethics@Bath, the University's new 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 APVC-R using pro-vc-research@bath.ac.uk. Please note that while the draft Organisation Information Document is authorised by the sponsor at the point of sponsorship approval, it is not signed by the University until REC approval has been issued.
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. |
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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 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.
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.
IRAS Form (for HRA&HCRW Approval and REC Favourable 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.
Copy of peer review/scientific critique or evidence that the proposed study has been peer reviewed and all comments incorporated into the study.
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.
Preparing New Projects in IRAS
New users to IRAS should consult the online guide. 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.
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 Associate Pro-Vice-Chancellor (Research) , Professor Julie Barnett. The APVC-R will receive copies of all correspondence from 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 completed by the VCO 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 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 audit and monitoring report by the Research Governance and Compliance Team.
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 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. In addition to our internal definition of amendments, these types of amendments are further classified as either substantial or non-substantial.
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 amendment 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 an amendment and how to use the amendment tool can be found here. The current version of the amendment tool can be accessed via this link.
Once the amendment tool is completed, you must submit it together with all relevant supporting information for review via the Ethics@Bath system.
When submiting your request for an amendment via Ethics@Bath please include the following documents with your amendments form:
- completed amendment tool
- 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 lock the amendment tool before returning it to you in as a PDF file. You can proceed with submission of the amendment following the guidance on IRAS.
For information on what happens once you submitted your amendment via IRAS 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 Research Governance and Compliance Team.
For further guidance on how to implement amendments 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.
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 Governance and Compliance 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.