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R&D Approval - Guidance for Directorate Research Leads
Guidance for Directorate Research Leads Approving Research
This is guidance for Research Leads who are asked to provide Directorate level approval for research.
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Why and when is R&D Approval required?
All research activity must be registered and approved by the Trust. R&D Approval is required for all projects using Trust:
Staff, patients, their tissue, organs or data or involving Trust facilities or equipment
The Trust will only extend NHS indemnity cover (for negligent harm) to its employees taking part in projects that have been registered with the R&D Department. The Trust therefore cannot accept liability for any activity that has not been granted R&D approval.
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Why is Directorate Level Sign-off of R&D Proposals Required?
The R&D Department undertakes the central review and approval of research proposals as this is essential for maintaining the Trust's indemnity and liability cover.
As each Directorate in the Trust has responsibility for the resource use and management of activity in their area, the central R&D Department can't make decisions about hosting the research on the Directorate's behalf. Directorate approval ensures that issues that can only be addressed at Directorate level are considered before organisational level approval is given.
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Information provided by researchers to Directorate Research Leads
Most of the information needed for Directorate review will be on the Site Specific Information (SSI) Form the researcher is preparing for their R&D and Research Ethics submission. You may also wish to review the protocol.
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Key considerations in providing Directorate level approval
• Financial issues
These should have been reviewed and approved by the Directorate Business Manager. It is important to note that in line with Trust Standing Financial orders, money from commercial sponsors must be paid into Trust exchequer accounts and NOT into charitable accounts.
• Capacity within Directorate to host the project
Issues around the capacity within the Directorate to host the planned research should be considered. Local knowledge of current service demands should be drawn upon when considering this issue, alongside discussion with Directorate colleagues where appropriate. Does the project fit into the Directorate research strategy?
• Capacity within Support Department to provide the services required by the study
The local Principal Investigator should address capacity issues with support departments such as Pharmacy, Pathology etc when developing their proposal, and ensure that their agreement has been confirmed.
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Peer Review
All research undertaken in the NHS Trust must undergo appropriate peer review. This is a key indicator of quality assurance. In cases where external review has not taken place, such as part of a grant-awarding process, arrangements must be made to have the project reviewed by an individual or group external to the research team. For student research the academic supervisor should carry out the review.
Researchers may request that you suggest an appropriate reviewer/s for their project or, where the proposal is low risk (please see guidance notes definitions of high & low risk proposals), provide a peer review of their study. Further information is available in the attached Guidance Notes for the Peer Review of Research Projects.
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Employment Contracts – For Information
Directorate Research Leads are not responsible for arranging employment contracts for research staff - this is the responsibility of the local Principal Investigator. This section is therefore for information only.
All individuals undertaking research in this organisation must have a contract of employment with the Trust (either full or honorary). Non-Trust researchers require an honorary contract if they:
- Have direct contact with patients or staff (including interviews and observations); or
- Visit Trust premises for the purposes of collecting or extracting patient-identifiable information or samples or using trust equipment: or
- Are Principal Investigators of projects which involve access to patient-identifiable information or samples (if the Chief Investigator of a multi-centre project is external to Leeds then the co-investigator based in Leeds will be designated the local Principal Investigator and should obtain an honorary contract).
If a non-Trust researcher requires an honorary contract the local Principal Investigator of the project should complete an honorary contract application form and forward it to the Directorate Personnel Department with a copy of the individual's CV and details of 2 referees. Directorate Personnel contacts will then process the application, issue a contract and inform the R&D Department.
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Providing evidence of Directorate Approval
Researchers should obtain the Directorate Research Lead's signature on the SSI form or for ask the Research Lead to provide a brief letter or email for R&D confirming his/her agreement. A letter template for this purpose is attached.
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