Research, Innovation & Engagement Support

This policy applies to clinical research activity under the sponsorship and co-sponsorship of the University of Glasgow.

Sponsor: The organisation responsible for ensuring appropriate arrangements are in place for the governance, initiation, management and financing of clinical research projects. In this context, the term refers to projects that fall within the UK Policy Framework for Health and Social Care Research (2017 and as updated)

Co-sponsorship: For trials that fall under the Medicines for Human Use (Clinical Trials) Act 2004 (as amended), the University and NHS GG&C have signed a Memorandum of Understanding to agree to act as co-sponsors in specified non-commercial clinical trials of medicinal products for human use. Under the co-sponsorship arrangement, one party may agree to perform certain elements of the study activity for which the other is responsible; this does not constitute a delegation of this responsibility.

Chief Investigator (CI): The person with overall responsibility for the running of a clinical research project, including development of the protocol.

Principal Investigator (PI): Where a study involves more than one research location, the PI is responsible for the running of the trial at their local site.

NHS Patient: For the purposes of this policy an NHS patient is any individual identified in the context of, or in connection with, their past or present use of NHS services and care, including services provided under contract with the private or voluntary sectors. This would include healthy individuals recruited to act as controls in the research and/or individuals recruited because of their status as relatives or carers of past or present users of these services.

Healthy Volunteer: For the purposes of this policy, a healthy volunteer is anyone who is recruited for a research study without reference to a medical illness or condition and without making use of NHS facilities.

Student Study: A research study where the primary purpose is obtaining an educational qualification. If the main purpose is to undertake a specific study and the educational qualification is secondary (i.e. if the study can be undertaken with or without the student, or if a student is joining the research team for an existing study), then this does NOT fall into the category of Student Research. 

1. Clinical Trial Co-sponsorship

1.1 The University and NHS GG&C signed a Memorandum of Understanding (MoU) in August 2004 to the effect that they would co-sponsor non-commercial clinical trials where the CI is substantively employed by the University of Glasgow. This MoU sets out the respective responsibilities of each organisation under this

In 2007, the University of Glasgow and NHS GG&C developed single and multi-site co- sponsorship agreements which must be put in place before a clinical trial can commence. These agreements clearly define the roles and responsibilities of the co-sponsors under the Medicines for Human Use Act (Clinical Trials) 2004 (as amended).

The University of Glasgow may consider third party co-sponsorship of trials with NHS GG&C. Consideration of this is on a case-by-case basis following a detailed risk assessment of each trial by the Head of Research Regulation and Compliance . Sponsorship decisions of this nature lie ultimately with the Head of the College of Medical, Veterinary and Life Sciences. A third-party co-sponsorship agreement has been developed and must be put in place before any third-party CI trial can commence.

The University of Glasgow may consider international co-sponsorship of clinical trials with NHS GG&C when these will take place within the European Union and other territories (excluding the USA and Canada).

In all cases, appropriate insurance cover must be obtained, and be in place, before a trial can commence (1.2). In addition, all relevant contracts must in place before a trial can commence.

1.2 Insurance / Indemnity arrangements: The NHS provides cover for clinical negligence for clinical trials taking place in the UK through its indemnity scheme (CNORIS). The University of Glasgow is responsible for ensuring indemnity is in place in respect of the actions of its employees, students and affiliates, including insurance for risks associated with the protocol, where it is developed by University

2. Clinical Research - Sponsorship under the Research Governance Framework

The UK Policy Framework for Health and Social Care Research (2017 and as updated) encompasses all research that involves NHS staff, patients, and/or their samples, tissue or data. Within the University of Glasgow and NHS GG&C, this definition is key to determining which organisation should act as sponsor for a research study.

2.1 When NHS GG&C will sponsor: Under most circumstances, NHS GG&C will sponsor research that involves NHS GG&C patients (please note the definition of NHS patient above), staff or resources. This is in line with the duty of care for these individuals.

This definition includes:

•  Studies that make use of data provided by the NHS regardless of where the work is undertaken, as the NHS retains responsibility for safeguarding their patients
•  Studies that are undertaken at NHS facilities including Clinical Research Facilities
•  Studies that involve tissue from NHS patients, including if it is processed at University facilities, provided that it is returned to the NHS for further processing or disposal

Confirmation of sponsorship: Where the NHS is sponsor, the research is assessed by an NHS Research Ethics Committee (unless one of the defined NHS REC-exempted categories) and approved via the NHS R&I/R&D Offices.

2.2  When the University will sponsor: The University of Glasgow will take on sponsorship for research where:

• Tissue is donated to the University by NHS patients and will not be returned to the NHS for further processing or disposal
• The research involves only healthy volunteers (see definition above)
• Recruitment does not involve NHS facilities or an association with NHS patients
• The research is conducted by a University of Glasgow matriculated student where the primary purpose is obtaining an educational qualification

2.3 Insurance / Indemnity arrangements: The NHS provides cover for clinical negligence through its indemnity scheme (CNORIS). Where the University is a sponsor, it will ensure adequate insurance / indemnity is in place and that the protocol has been assessed for risk.

The point of contact for all University of Glasgow sponsorship enquiries is:

Research Regulation and Compliance Team rrc@glasgow.ac.uk