Responsibilities of the Sponsor

What is a Sponsor?

Under the Research Governance Framework for Health and Social Care (RGF) and the Medicines for Human Us (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 trial, the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial.

In general

The Research Governance Sponsor is normally the organisation which substantively employs the Chief Investigator. The Chief Investigator has the responsibility for managing the trial (writing the protocol, managing and running the study, enrolment of patients, reporting to regulatory authority as required and writing the study report) this is regardless of where the project will take place.  Some of these main responsibilities can be formally delegated to other persons or institutions. For any research that takes place in the context of the NHS in England there must be a sponsor. If the sponsor is outside the United Kingdom, it must have a legal representative in the United Kingdom.

Where the study is funded by a research council, medical charity or other non-commercial body, the funder may be willing to act as a Sponsor, especially if it employs members of the research team or retains an interest in any intellectual property that is generated. 

Student Projects or Projects undertaken as part of an academic course

Where a project is being undertaken as part of academic study, then the University where the course is being undertaken will be the Research Governance Sponsor. This is regardless of where the project will be taking place and where the patients are being accessed. The University and the project supervisor are responsible for the design, management and running of the study. LCHS NHS Trust will extend normal indemnity arrangements to projects which are being undertaken by normal R&D approval arrangements. The student and supervisor will be responsible for ensuring that they have checked that all regulatory approvals are obtained prior to the project commencing.

CTIMP (Clinical Trials of an Investigational Medicinal Product)

If no formal sponsor is formally identified the clinical trial may not proceed within the LCHS NHS Trust. 

LCHS NHS Trust Sponsorship

LCHS NHS Trust may agree to act as Sponsor. In order to accept this responsibility, the organisation needs to be assured that there are adequate arrangements in place for the management of the study. The Researcher must contact the R&D department at the draft protocol stage, if their study requires sponsoring by LCHS NHS Trust. 

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.

ICH Good Clinical Practice guidelines on Sponsor responsibilities:

 ICH Good Clinical Practice Guidelines