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Obtaining sponsorship for research studies

What is a Sponsor?

A sponsor is an organisation which takes responsibility for the quality and conduct of a research project. All research conducted within the NHS is required to have a research sponsor.

The sponsor can be defined in two ways:

  • The Research Governance Framework describes a sponsor as an 'individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study'.
  • The Clinical Trials Regulations describes a sponsor, in relation to a clinical trial, as the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial.

What does a Sponsor do?

A sponsor is required to ensure that:

  • The dignity, rights, safety and wellbeing of participants are given priority at all times
  • The research proposal is worthwhile, of high scientific quality and represents good value for money
  • An appropriate research ethics committee has given a favourable opinion to the research proposal
  • Appropriate arrangements are in place for the registration of trials
  • The principal investigator, and other key researchers, have the necessary expertise and experience and have access to the resources needed to conduct the proposed research successfully
  • Arrangements proposed for the work are consistent with the applicable laws, guidance and regulations, including ICH GCP, Medicines for Human Use (Clinical Trials) Regulations and/or the Department of Health Research Governance Framework
  • An agreement has been reached about the provision of compensation in the event of non-negligent harm and any organisation, including the sponsor itself, offering such compensation has made the necessary financial arrangements
  • Arrangements are proposed for dissemination of the findings

University or Trust?

The Sponsor will usually be the Chief Investigator's employing organisation, the lead organisation providing health or social care, or the main funder. For research undertaken as part of a qualification, the university at which the student is registered should act as sponsor. Details on the sponsorship processes for the University of Bristol and the University of the West of England are available on their websites:

University of Bristol

University of the West of England

UH Bristol - how to apply

If you wish for the Trust to act as sponsor for your research study you should:

1. Contact any departments within the Trust who will be asked to provide resources or services and where necessary arrange an appointment to discuss what is required.

2. Complete a  'Request for UHBristol to be Research Sponsor' form and e mail a copy to r& .  A copy of the study protocol should be included with the request form. At this stage it is acceptable to name UH Bristol in the protocol as the sponsor of the study, despite formal approval not having been received. In the event of the Trust not agreeing to sponsor the study the protocol will, of course, need to be amended.

On receipt your form will be reviewed by a member of the team and if fully completed your application will be referred to the Research & Innovation Management Team.  The team meet on a weekly basis to discuss requests for sponsorship, and will make an assessment of whether UH Bristol would be a suitable organisation to act as sponsor for your project. You will receive a response as to whether your study will progress into the sponsorship process within 7 working days

3. If your study is considered suitable for sponsorship you will receive an e mail from the team informing you that a record for your study has been created on the EDGE research management system and a Research Management Facilitator and R&I reference number have been allocated. You will also be asked to send the following documents:

  • Final study protocol*
  • Study costing and funding award letter
  • Support department pro formas*
  • Chief Investigator CV
  • Evidence of peer review (if not previously submitted).

*Before agreeing to act as sponsor the Trust will need assurance that the protocol contains all required information. Guidance on writing a protocol can be found in the associated SOP (Standard Operating Procedure).

**Pro-formas should be completed for feasibility and used as a basis for discussion when contacting support departments e.g. pharmacy, radiology, laboratory medicine or MEMO. 

Assessing Scientific Quality

  • If your study has been or will be reviewed for scientific quality by an external funder and this can be evidenced it may not need further review.
  • Where external review has been conducted you must send us a copy of the reviewers' comments and any responses.
  • If the study has not been reviewed by an external funder, you can either:
  • Obtain peer review from two reviewers who are independent to your study by requesting that they complete the Scientific Review Form.  Send these completed forms, along with their accompanying emails (if applicable) to the Research Management Office as part of your submission for sponsorship. Or,
  • Request that the Research Management Office arrange for this to be undertaken for you, prior to agreeing to act as sponsor.*

*When appropriate reviewers have been identified, your allocated Research Management Facilitator will make contact with the reviewer and ask whether they would be willing to review your study. If the reviewer agrees, a 2 week time period is given within which we would ask for the review to be undertaken. Any comments or suggestions for improvement would then be fed back to the applicant. If amendments are suggested, a revised protocol or rationale for being unable to accommodate the amendments would be fed back to the reviewer to give their opinion. Please note we are reliant on reviewers having sufficient time within their clinical workload to carry out reviews and as a consequence the 2 week time period may not be adhered to. The RMO will chase the reviewers where possible but this process can take an extended period of time. It is therefore strongly recommended that where there is urgency in opening the study in a short timeframe the CI obtains peer reviews themselves prior to submission for sponsorship.

  • Where the Trust agrees to act as sponsor we will provide a provisional sponsorship letter outlining responsibilities; the Trust may then be named as the sponsor on subsequent applications to the MHRA (Medicines and Healthcare Products Regulatory Agency) and NRES (National Research Ethics Service).
  • UH Bristol's agreement to act as sponsor is not approval for the study and is conditional on full Trust approval being gained through the normal study approval processes

When sponsorship has been issued, requests for electronic authorisation by the sponsor on the IRAS system can be sent to (r&

A minimum of 6 weeks should be given from initially requesting that UH Bristol act as sponsor before submitting an application to the Research Ethics Committee.