Who is the UoB sponsor contact?
The Sponsor is Professor Julie Barnett, Associate Pro-Vice-Chancellor (Research)
The University of Bath
Who is the lead NHS R&D contact?
The lead NHS R&D contact may be the R&D contact for:
- The Chief Investigator's employing NHS organisation
- A partner NHS organisation of the university employing the Chief Investigator
- A main NHS collaborator
The contact details for the lead NHS R&D can be found on the NHS R&D Forum
How long should data be kept?
Please see the University's Records Retention Schedule
Please see guidance for details about the length of time you can store research data.
Is an OID (Organisation Information Document) needed for Participant Identification Centres (PICs)?
No. PICs are not research sites and as such are not set up in the same way as research sites. A model non-commercial PIC agreement should be used with NHS organisations acting as PICs. Further guidance and the template agreement can be found here.
How long will the internal Sponsorship review take?
Please allow at least 2 weeks from the date all documents are received by the Research Governance and Compliance Team.
Do I need NHS REC approval?
Please complete the decision tool to confirm what type of approvals you require.
What is a SoECAT?
The Schedule of Events Cost Attribution Template (SoECAT) captures and calculates the different activities and costs associated with clinical research in a standardised and consistent way. It is completed at the point you are costing your project.
All researchers applying for certain clinical research grants will need to complete a SoECAT as part of the grant application process. This allows funders to receive reassurance that the cost activities within the study have been attributed correctly in line with AcoRD.
The SoECAT and additional guidance can be found here.
Where can I find examples of Participant Information Sheets (PIS) and Informed Consent Forms (ICF)?
HRA guidance and template can be found on their website.
How do I register a study on clinicaltrials.gov?
The University has an account, and researchers should register for a ‘PRS Individual Account’ under the overarching University account using this link and submit the information directly.
The registration asks for an 'organisation contact'. Please include Professor Julie Barnett's contact details firstname.lastname@example.org
Do I need to obtain peer review?
As per the UK Policy Framework for Health and Social Care Research it is a requirement for sponsors to have in place adequate peer review systems proportionate to the research activity. The sponsor is responsible for the assessment of the scientific quality of the proposed research. The research proposal must be subjected to review by experts in the relevant fields able to offer independent advice on its quality. Arrangements for review should be commensurate with the scale of the research and the potential risks or burdens involved for participants. The level of peer review for UoB sponsorship depends on the potential risk, prior peer review or type of study (staff/student).
Doctoral students and staff whose research has not been reviewed externally as part of a competitive funding round, will require peer review by two external reviewers. An external reviewer would be someone suitably experienced in the research area who has no direct involvement in the set-up, funding or management of the proposed research project.
All other students require 1 internal review (supervisor) and 1 external review.
Peer reviewers should consider whether (i) it is clear why this research is exciting/original/transformative (e.g., if the aims, research questions and hypotheses address a gap in existing knowledge), (ii) it is clear why the research question is important to society, and (iii) there is adequate reference to similar work done by others.
For more information please see guidance on the NHS HRA website
Can doctoral students be Chief Investigators?
The UK Policy framework stipulates that 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. For undergraduate and master’s courses, the supervisor should always take the role of chief investigator. For PhD courses, the student may take the role of chief investigator if the supervisor and the sponsor agree that this is appropriate. If a special case needs to be made to have a Doctoral Student take on the role of CI, instead of the Supervisor, a request will need to be made in writing to email@example.com before Sponsorship is requested. This request should explain how the Doctoral Student is better placed to take on the CI’s responsibilities as defined in the framework.
For further information
For further information re the process of obtaining Sponsorship please review our guidance here