Sponsor

.

• Sponsor principles
• WAHT process for requesting sponsorship
• University of Bristol processes
• University of the West of England, Bristol (UWE) processes

What is a sponsor?

Under the Research Governance Framework for Health and Social Care (RGF) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (Clinical Trials Regulations) the Trust is required to have oversight of research it sponsors and hosts.

The sponsor is defined in two ways:

• RGF: Sponsor: 'Individual, organisation or group taking on responsibility for securing the arrangements to  initiate, manage and finance a study.'
• Clinical Trials Regulations: "sponsor" means, in relation to a clinical trials, the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial'

The sponsor will usually be the Chief Investigator's employing organisation, or 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.

For any research study covered by the Medicines for Human Use (Clinical Trials) Regulations and the Research Governance Framework, the sponsor must be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing.

Discussions with prospective sponsors should start during the protocol development phase to ensure all their requirements are incorporated prior to ethics review.

Roles of a sponsor:

An organisation with the status and authority to sponsor research in health and social care must be in a position to ensure that:

• The dignity, rights, safety and well-being of participants are given priority at all times by the research team.
• The research proposal is worthwhile, of high scientific quality and represents good value for money.
• An appropriate research ethics committee has approved 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.
• The arrangements and resources proposed will allow the collection of high quality accurate data and the systems and resources being proposed are those required to allow appropriate data analysis and data protection.
• Intellectual property rights and their management are appropriately addressed in research contracts or terms of grant awards.
• 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.
• Organisations and individuals involved in the research all agree the division of responsibilities between them.
• There is a clear written agreement identifying the organisation responsible for the ongoing management and monitoring of the study, whether this is the organisation employing the researchers, the sponsor, or another organisation.
• Arrangements are in place for the sponsor and other stakeholder organisations to be alerted if significant developments occur as the study progresses, whether in relation to the safety of individuals or to scientific direction.
• 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.
• All scientific judgements made by the sponsor in relation to responsibilities set out here are based on independent and expert advice.
• Assistance is provided to any enquiry, audit or investigation related to the work.

More detailed information regarding the responsibilities of the sponsor for trials using investigational medicinal products is available from the Department of Health website and the Office of Public Sector Information (SI 1031 and amendments).