Study Approval Process Flowchart

A flowchart has been created to advise on study approval by a local NHS Trust and University of Hull, describing the route for a commercial clinical trial, a charitable body or research council application, or an in-house project.

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Research Study Approval

All research work carried out in the Trust by Honorary or contractual staff, using facilities or involving Trust patients or staff requires Trust approval as well as Local Research Ethics Committee (LREC) approval before proceeding.

For Trust Approval

Please submit one copy of the following to the Trust R&D Office:

(Note: The COREC and R&D forms should be submitted in .pdf & .xml format as well as a paper copy)

• A Study Protocol or Proposal (See template).
• A completed R&D Application Form
• A Patient/Subject Information sheet, Informed consent form and GP letter (See template)
• A copy of the Ethical Committee submission-parts A and B, and C if applicable. Part D is not necessary as the above resource form covers this.
• If the study has been considered by the LREC or an MREC, copies of Ethical Committee correspondence from and to the committee including approval letter.
• The submission should be made electronically

For commercially sponsored studies you will need to submit:

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• Proposed financial and study agreement. The Trust is now using the model Clinical Trial Agreement as approved by the DoH, ABPI, and the NHS. For a copy of this agreement please contact Nina Dunham on 01482 623206.

If the study involves researchers working in the Trust who are not Trust employees an Honorary Contract will be required

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• Submit a copy of the researchers' CV together with information clarifying the Trust based supervisor and length of time the researcher may need access to the Trust (premises, patients and/or staff).

For Ethics Committee Opinion

Local Research Ethics Committee (LREC) approval is a separate process. For submission to the LREC:
Please complete the application form and ring LREC for an application number. Submit the form to the appropriate LREC. This can be done electronically, but must be followed up by a signed hard copy.
For multi-centre studies involving 2 or more centres in the UK, the same application form needs to be sent to an appropriate MREC and only part C to an LREC for site specific assessment (where applicable).

Independent Peer Review

Due to the DoH Research Governance Framework, all studies have to go through an Independent Peer Review, to assess the quality of the study. The Trust is responsible for obtaining such a review.
To help speed up the overall approval process, you can if you wish obtain a review yourself - by someone you feel is qualified to review the area of your research, but is not directly involved in the project. To help with the review, we issue a Review Sheet, which can now be downloaded and filled in by the reviewer.

Federal Wide Assurance

Any trial that is funded by, or in collaboration with, any American funding body, needs to have FWA. the Trust has applied for and received this due to a recent trial needing it. The Assurance is valid for 3 years, and will cover any other studies that require it. Contact the department for the Assurance number if needed.