All research requires a sponsor. The sponsor is the individual, company, institution or organisation that takes on legal responsibility for the initiation, management and/or financing of the research.
Specifically, the sponsor takes responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.
The sponsor's responsibilitiesThe sponsor's responsibilities
The sponsor is responsible for checking that:
- Independent scientific peer review has demonstrated that the research is deemed to be worthwhile and high value for money.
- The necessary resources are in place to deliver high quality, value for money research.
- The investigators, research team and research sites are suitable.
- The division of responsibilities within a project are agreed and documented.
- The appropriate approvals are in place before research begins.
- Any necessary permissions/licences are acquired before research begins.
- The appropriate indemnity is in place before research begins.
- Systems are in place to investigate complaints and deal with any misconduct.
- Systems are in place for reporting, recording and reviewing any adverse events.
- Agreements are in place for the identification, protection and exploitation of Intellectual Property.
- The research is managed and conducted according to all relevant law and good practice (including General Data Protection Regulation, 2018; Human Tissue Act, 2004; Mental Capacity Act, 2005).
- The research is conducted in accordance with the approved protocol and the terms and conditions of the relevant approvals.
- The research is subject to monitoring.
- Key research records and documents are maintained in a legible condition.
- Any modification to the design of studies is approved by the sponsor, and arrangements are in place to obtain any further necessary approvals.
- There are arrangements in place for notifying any relevant approval bodies when the research is finished.
- Any data collected is retained for the appropriate period.
- There are appropriate plans for the dissemination of study findings.
Who is the sponsor?Who is the sponsor?
A sponsor can delegate specific responsibilities to any other individual, company, institution or organisation that is willing and able to accept them. Any delegation of responsibilities should be formally agreed and documented by the sponsor.
Newcastle University acts as the sponsor automatically for most research undertaken by Newcastle University staff and/or students.
The key exception is for research involving NHS/HSC facilities, staff or service users.
Research that involves NHS patients, staff, services and/or facilities may be sponsored by either the NHS trust or Newcastle University, as detailed below.
- The NHS trust will act as sponsor for projects, involving Secondary Health Care (e.g. Newcastle upon Tyne Hospital NHS Foundation Trust, NuTH) patients and/or facilities, AND where the principal investigator is a staff member of NuTH or of Newcastle University’s Faculty of Medical Sciences (FMS).
- Newcastle University will act as sponsor for all other projects including, for example, projects involving Primary Health Care (GPs, community pharmacists, opticians, dentists), and projects where the principle investigator is a Newcastle University student or a non-FMS staff member.
What do you need to do?What do you need to do?
If your research does not involve NHS/HSC facilities, staff or service users, your research will automatically be sponsored by Newcastle University. On completing your ethics application, you will not need to take any further action, but you should ensure that your study is conducted in line with Newcastle University's research policies and procedures.
If your research involves NHS/HSC facilities, staff or service users, you will need to apply for sponsorship:
If you wish to recommend any changes to the information above, please contact email@example.com.