Governance
Clinical research governance may be defined as the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality.
Sponsorship
The Sponsor Office at the University takes responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study, and provides formal sponsor approval for relevant University-led clinical research studies.
Sponsorship is required for clinical research that involves NHS staff, patients or their data, or NHS facilities.
A more detailed explanation of the sponsorship process and the type of study that requires sponsorship can be found on the Clinical Directorate Intranet (staff only).
All applications for sponsorship should be made using the LHP SPARK Joint Research Service sponsorship application form.
Further information on sponsorship
Any queries about Sponsorship should be directed to the Sponsor team via sponsor@liverpool.ac.uk
The sponsor is the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. All health and social care research requires a sponsor. This includes all research that involve NHS patients, their tissue or information. The University also requires that Human Health related based Studies taking place at international sites obtains Sponsorship.
Does my project require sponsorship?
As per POL001, the University requires Sponsorship be obtained for the below types of research where the CI is an employee of the University;
- Involvement of patients and users of the NHS including use of their data, tissue or other bodily material
- Involvement of relatives or carers of NHS patients
- Use of NHS premises or resources
- Recruitment of NHS Staff as participants
- Any Clinical Trial of Investigational Medicinal Product (CTIMP), regardless of the proposed participant population
- Human Health related based Studies taking place at international sites
- Recruitment of participants who lack capacity to consent
- Research involving participant exposure to radiation
- Research involving identification and recruitment of participants via private healthcare providers, including from Care Homes and palliative care facilities.
The University may require Sponsorship be obtained for research that may not be listed above if there is deemed to be a risk to the institution and as such require a higher level of oversight. Any such decision will be made between the Senior Clinical Research Governance Manager and the Chair of the SPARK Sponsorship Committee.
Will the University sponsor my research?
The University will consider undertaking sponsorship for the following:
- Research being undertaken by employees of the University
- University Student research projects (where the academic supervisor is a University employee)
- Submissions from Investigators external to University will be considered on a case-by-case basis, but it is expected the employing organisation will undertake the role of Sponsor.
Policies and Standard Operating Procedures
The University has developed Policies and Standard Operating Procedures (SOPs) to provide guidance to researchers and to ensure that their responsibilities are met.
View our Policies and Standard Operating Procedures.
Human material
The use of human tissue for research purposes is governed by the Human Tissue Act 2004 and any subsequent amendments. This legislation regulates the removal, storage, use and disposal of human tissue defined as 'relevant material' from both the living and the deceased for 'scheduled purposes'.
If you plan to carry out any research with human material, you must have the appropriate approvals in place before you start your research. All researchers are responsible for:
- Gaining sponsorship, where appropriate as required according to UK Framework for Health and Social Care Research or the Medicines for Human Use (Clinical Trials) Regulations 2004
- Obtaining appropriate ethical approval to use human material
- Providing annual returns detailing the samples held on University premises to the Human Tissue Act Designated Individual upon request.
More details, including an overview of our Human Tissue Act 2004 responsibilities and a list of accessible Research Tissue Banks can be found on the Human Materials webpage (staff only).
Clinical research governance team drop-in sessions
The clinical research governance team are holding drop-in sessions for staff and students to discuss any questions or queries relating to sponsorship and human material.
Sessions will be held most Wednesdays between 10-12 am and conducted through Zoom.
To book one of the forthcoming drop-in sessions, please complete the registration form.
You will receive a time slot and link to join the session by email on the day of the drop-in.
Contact
Any queries about sponsorship and human material governance should be directed to the appropriate team
Sponsorship Team
Email: sponsor@liverpool.ac.uk
Tel: +44 (0)7717 863747
Human Material
Email: humanmat@liverpool.ac.uk
Tel: +44 (0)7799 343797