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:
- 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;
- satisfying itself that the investigators, research team and research sites are suitable;
- 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;
- 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
- 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);
- 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;
- verifying that regulatory and practical arrangements are in place, before permitting the research to begin in a safe and timely manner;
- putting and keeping in place arrangements for adequate finance and management of the research project, including its competent risk management and data management;
- 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.
