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Research and knowledge exchange

Sponsorship Sub-Committee

The University's Sub-Committee has formal responsibility for oversight of all Âé¶¹´«Ã½ÉçÇøÈë¿Ú sponsored research.

SSC Committee dates | Covid-19 requirements

Overview

When is it appropriate for the University to Sponsor?

Preparing documents

PSRP and formal acceptance of Sponsorship

Once Sponsorship has been granted (HRA processes)

Standard Operating Procedures

Key links and resources


Please note that the University reserves the right not to sponsor studies when it believes the proposed project constitutes a risk to the organisation on patient safety, financial or legal grounds.

Overview

The Sponsorship Sub-Committee (SSC) has responsibility for formal oversight to all forms of sponsored research

  • acceptance of Sponsorship
  • amendment requests
  • protocol deviations/ breaches of Good Clinical Practice (GCP)
  • Serious Adverse Event (SAE) notifications
  • reports to NHS Research Ethics Committees (RECs) 

Researchers wishing to submit to the  Sponsorship Sub-Committee should ensure they check the meeting and submission dates in good time to plan their research activity. Please contact researchsponsorship@sussex.ac.uk 

* Should you wish to receive sponsorship for a study, please ensure that you understand how both the  and the Sponsorship Sub-Committee Operate *

When is it appropriate for the University to Sponsor?

  1. For the University to act as sponsor the Chief Investigator (CI) must be a substantive employee of the University.
  2. The Sponsor needs to be satisfied that the CI is appropriately qualified as demonstrated by their C.V. and training record.
  3. It is expected that research will be funded and that funding will sit with the University.
  4. Unfunded projects will only be considered if there is a clear route to future funding and two external peer reviews from two independent and expert reviewers[1].  Direct costs for sponsorship are the responsibility of the researcher who must clarify the source of funds.
  5. Requests for sponsorship of internally funded projects must be supported by external peer review2.
  6. Post graduate research and Masters student projects (where applicable[2]) must have a supervisor who is substantively employed by the University. Where the student is the proposed CI instead of the supervisor, the supervisor must be willing to take over the role of CI should there be an unforeseen absence of the student.  
  7. If a CI leaves the University and funding for the project moves with them, arrangements must be made for sponsorship to be transferred to the new institution in advance of the CI leaving the University.
  8. In advance of securing sponsorship, the proposed CI must identify a substantively employed member of staff who is competent and willing to take over the role of CI should there be any absence of the CI e.g., maternity cover, extended sickness absence. The Sponsor needs to be satisfied that the temporary CI is appropriately qualified, as demonstrated by their C.V. and training record. A change of CI would need to occur through a substantial amendment request to the sponsor and subsequently the REC.
  9. Co-sponsored studies must be accompanied by a contract outlining responsibilities of each co-sponsor.
  10. Clinicals trial of an investigational medicinal product (CTIMPs) and Clinical Investigation of a Medical Device (IMD) studies must always have a clinical trials unit to support[3].


[1] Independent reviewers must be external to the host institution, have no conflict of interest and not involved in the study in any way. Independent reviewers must also be expert reviewers. Expert reviewers should have knowledge of the relevant discipline to consider the clinical and/or service based aspects of the protocol, and/or have the expertise to assess the methodology and statistical aspects of the study.

[2]

[3]

Preparing documents

The are the minimum required to ensure sponsorship review. The Âé¶¹´«Ã½ÉçÇøÈë¿Ú  SSC also requires in addition:

  • After PSRP recommendation: A letter to the Chair of the Sponsorship Sub-Committee with an overview of the study indicating in a numbered list how each of the points raised by the PSRP has been addressed. Documents that have been amended in response to review should feature tracked changes and updated version control.

 To avoid delays in receiving University sponsorship, please submit to researchsponsorship@sussex.ac.uk at the same time as sending to psrp@sussex.ac.uk

Applicants are strongly advised to read carefully the  to understand the subsequent processes to be followed and the documents needed to support an application.

PSRP and formal acceptance of Sponsorship

Once the PSRP has recommended your application to the Sponsorship Sub-Committee for formal Âé¶¹´«Ã½ÉçÇøÈë¿Ú sponsorship to be granted (and a letter has been issued to confirm this), you will be able to proceed with gaining HRA and NHS Research Ethics Committee approval.

The majority of studies that are reviewed by the PSRP will be accepted for Sponsorship (after receiving recommendation from the Panel) by Chair's Action between SSC meetings. Exceptions to this are:

  • Applications for clinical trials of investigational or medicinal products (CTIMPs)
  • Applications for research tissue banks (RTBs)
  • Basic science studies (or similar) requiring specific medical supervision and oversight and/or those specifically requiring the declared University’s Clinical Trials insurance extension in addition to standard insurance
  • Any other studies identified as leading to non-standard risks or additional liabilities to the Sponsor (typically invoking additional insurance or specific risk mitigation measures)

All researchers who have been granted University Sponsorship are required to agree to follow the University's Conditions of Sponsorship Agreement.

Once Sponsorship has been granted

The Chief Investigator will follow  until formal notification of approval.

HRA approval

 

The Chief Investigator has the responsibility to ensure that all amendments, Serious Adverse Events, Annual Progress Reports, protocol or GCP breaches and end of study reports are submitted to the Sponsorship Sub-Committee (in addition to requirements stipulated by the HRA or MHRA (CTIMPs). Please see http://www.sussex.ac.uk/staff/research/governance/sponsorship/sponsorshipduties for further details.

All queries should be submitted to researchsponsorship@sussex.ac.uk