Sponsorship

What is a Sponsor?

It is a requirement of the UK Policy Framework for Health and Social Care Research (PDF, 380kB) that any research governed by it (broadly speaking any research that requires an IRAS application) must have a designated Sponsor, who takes ultimate responsibility for the oversight of the research project. The Sponsor will usually be:

  • an academic organisation,
  • an NHS Trust,
  • or a commercial company (typically a pharmaceutical company).

Responsibilities

The Policy Framework states that Sponsors are ultimately responsible for:

  1. identifying and addressing poorly designed or planned research and poor-quality research proposals, protocols or applications and ensuring that research proposals and protocols:
    • take into account systematic reviews of relevant existing research evidence and other relevant research in progress,
    • make appropriate use of patient, service user and public involvement and
    • are scientifically sound (e.g. through independent expert review) (For educational research, the scientific validity and quality may be established by the chief investigator (i.e. the supervisor) at a level appropriate to the nature of the course), safe, ethical, legal and feasible and remain so for the duration of the research, taking account of developments while the research is ongoing;
  2. satisfying itself that the investigators, research team and research sites are suitable;
  3. ensuring that roles and responsibilities of the parties involved in the research and any delegation by the sponsor of its tasks are agreed and documented;
  4. ensuring adequate provision is made for insurance or indemnity to cover liabilities which may arise in relation to the design, management and conduct of the research project; and 
  5. ensuring appropriate arrangements are made for making information about the research publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee); agreeing appropriate arrangements for making data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after it has finished; and ensuring arrangements for information about the findings of the research to be made available, including, where appropriate, to participants (For educational research, registration, accessibility of data and tissues, and dissemination may be limited to institutional arrangements);
  6. ensuring that, where expected or required, the research has approval from a research ethics committee (Whether outright or following a provisional opinion, resubmission or appeal) and any other relevant approval bodies before it begins;
  7. verifying that regulatory and practical arrangements are in place, before permitting the research to begin in a safe and timely manner; 
  8. putting and keeping in place arrangements for adequate finance and management of the research project, including its competent risk management and data management; 
  9. ensuring that effective procedures and arrangements are kept in place and adhered to for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments.

Commercial Sponsors are generally also the Funder of the project, but the Funder of a project is not necessarily the Sponsor.

A Non-Commercial Sponsor (NHS or academic) would generally be the employer of the Chief Investigator. However, this is not automatic. The organisation must be asked to take on the role of Sponsor, and will only agree to do so if they believe that it is in the best interests of their organisation.

University of Bristol as Sponsor

If you are an employee, are studying for a PhD or are the supervisor of a Masters student at the University of Bristol, you can request Sponsorship by the University. If this is agreed, the Research Governance Team will act as the Sponsor's Representatives.

Application for UoB sponsorship

The first step for any UoB sponsored study will be to complete a Research Registration Checklist (Microsoft Forms)‌, if you have not already done so.

A member of the Research Governance Team will contact you to arrange to review your study documents and your IRAS form and will manage your application process. They will also be able to advise you on appropriate collaboration agreements for any external research sites (this may mean referring you to Research Contracts if an mNCA or non-standard agreement is required).

When can I start?

Once all required approvals and agreements are in place, Research Governance will issue a confimation of Sponsorship. You must not carry out any study-related procedures until this confirmation is in place.

Peer review

It is a responsibility of the Sponsor to ensure that appropriate peer review has been conducted. For most funded research, this will have been conducted through the funding process and we simply need to see confirmation of this. However, if your research is unfunded or the funder did not require a peer review, this does not mean that we do not require proof of independent peer review. The only exception to this is educational research: if an academic supervisor is acting as Chief Investigator they may attest to the scientific validity and quality of the study. 

Safety reporting

As part of the application process, Research Governance will review the intended safety reporting process in your protocol. This should be proportionate to the nature of your study while meeting any applicable REC/MHRA expectations. Where there is any requirement to Report events to the Sponsor, this is managed on our behalf by University Hospitals Bristol and Weston NHS Foundation Trust (UHBW). Research Governance will provide you with appropriate contact details.

Breaches

A Breach is any deviation during the course of the study from your approved study protocol or from the Conditions and Principles of Good Clinical Practice. If a Breach occurs, you must notify Research Governance as soon as possible after your becoming aware of it. We will then, as Sponsor Representatives, determine whether any further reporting is required, or if it is sufficient to document the Breach along with all Corrective and Preventative actions taken in response to it.

Monitoring

Monitoring is a formal process of reviewing the conduct of a research project, usually during that conduct but sometimes retrospectively. Your study may be monitored because a concern has been raised or, more commonly, because it has been randomly selected as part of the 10% annual monitoring of our study portfolio. Monitoring activities are conducted on our behalf by UHBW. Staff from their Research and Innovation department (R&I) will contact you directly to arrange monitoring. It is a requirement that all necessary records are made available to the Monitors; this includes participant records - agreement to this access should be included in consent forms.

Amendments to sponsored research

If you need to make any change to a study over the course of its conduct, this is referred to as an Amendment. This could be, for example, a change to protocol procedures, to participant-facing documents, to key study-staff, to the sites conducting the study, etc.

For any such change you will need to complete the Amendment Tool. You can find the current version of the tool in the IRAS Help pages. This may be updated without prior warning and you are expected to submit using the current version,so please download from IRAS each time, rather than saving a local version.

Once you have selected the appropriate categories to describe the nature of your amendment, the tool will determine for each of the bodies that approved your study whether this is a Substantial Amendment, requiring full review; a Non-Substantial Amendment, requiring formal submission and acknowledgement; or a non-Notifiable Amendment, which will be managed by your sponsor.

Categories will be checked as part of Sponsor Review, to ensure that they are the most accurate available descriptions of the intended changes.

Sponsor review

It is a requirement that the Sponsor organisation review Amendments prior to their being submitted. Once you have drafted the Amendment Tool, please send it to research-governance@bristol.ac.uk, in its original Excel format.

Leave lines 8 & 9 and all of Section 3 blank, these will be completed by the Sponsor.

Once the form has been reviewed and agreed, it will be returned to you as a pdf. It should then be submitted via the IRAS amendments system, for which you will need to create an account, in addition to your regular IRAS account.

Annual reports and end of study/trial

Annual reporting

From 1 August 2024, the HRA removed the requirement to make annual progress reports to the REC. More information is available on the HRA Website.

At the end of the study, an End of Study notification must be submitted to the approving REC. More details can be found at the HRA. For UoB Sponsored studies, Research Governance will prompt you when these are due, but it is the Chief Investigator's responsibility to ensure that they are submitted.

CTIMPs and CIMDs

In addition, MHRA approved studies are required to submit a Development Safety Update Report to the MHRA, every twelve months from the date of your initial CTA, and an End of Trial notification within 90 days of the Protocol defined end-point (or within 15 days of termination, if the trial terminates early for any reason). 

In this case, Research Governance will prompt the investigator team to complete the relevant document, but we will then review and submit it via our central account.

Archiving

After closure, documents and data should be archived as described in your IRAS submission and Protocol, and in accordance with any requirements that your funder may have. So long as the process is as planned, you do not require any approval to do this.

It is not required that you retain things in multiple formats, if paper records have been digitised, they can be destroyed - however it is required for CTIMPs, and recommended for all studies, that validation / QA be conducted to ensure that scans are complete, accurate and legible, prior to the destruction of paper copies.

Destruction

After the archiving period has elapsed, records can be destroyed completely, but you must first seek the approval of the Sponsor and the Chief Investigator.

University of Bristol as host site

If a study is being Sponsored by another organisation but research procedures will be conducted at UoB premises or facilities, then UoB will need to be setup by the Sponsor as a host site. You will need to complete a Research Registration Checklist (Microsoft Forms) so that we have the necessary details to register the study and to determine whether any additional oversight is required.