NHS Imperial College and Imperial College Healthcare NHS Trust sponsorship process
All healthcare research projects must gain sponsorship approval from the Research Governance and Integrity team (RGI team) on behalf of Impeial College or Imperial College Healthcare NHS Trust.
Research projects must apply for sponsorship with Imperial College or ICHT whether they are a clinical trial of an IMP or device, human tissue project, observational or epidemiological study.
The RGIT aim to give you a response on registration within 5 working days where possible subject to pressing deadlines of which we are made aware.
IC sponsorship
Registration is required as it allows the RGIT to:
- Assess for Imperial College or Trust sponsorship of your project (as applicable)
- Confirm or arrange appropriate insurance cover for your study
- Discuss research governance issues with you if required
- Ensure you have the necessary regulatory approvals
- Have an overview of the RGIT’s clinical research portfolio and respond to monitoring/audit requests by regulatory authorities
Registration needs to occur prior to submission of your ethics application and before project initiation
Registering is a simple process for projects in which you require the College or Trust to act as sponsor.
Please complete the following documents and send them to the RGIT inbox:
- A completed RGIT_TEMP_021_Sponsorship and Insurance Request Form.docx
- A copy of the research protocol RGIT_SOP_012_Protocol_design_v12.pdf
- A copy of the IRAS form
- And the participant information sheet and consent if applicable: RGIT SOP's
- All study other related documentation i.e questionnaires
- An Organisational Information Document and Schedule of Events (or SoECAT if done at gran stage) for sites outside of ICHNT
The Research Governance and Integrity Team (RGIT) will register the project and advise you on research governance issues if needed. We are happy to arrange to meet with you at your office or laboratory if you would find this helpful.
The RGIT will also do the following (as necessary) for your particular project:
1. Assess for Imperial College or Trust Sponsorship, where applicable.
If you want Imperial to act as the research sponsor, the RGIT will risk assess your project and make a decision on sponsorship.
The RGIT will confirm Imperial College or Trust sponsorship to you by email with a scanned letter and insurance confirmation if applicable. You must not assume that Imperial College will sponsor your project until you have received this confirmation.
The Facilitators will also review the IRAS form, protocol, participant information sheet and consent form for you to ensure that these meet all ethical and regulatory requirements.
2. Assess and confirm insurance cover.
It is extremely important that appropriate insurance is in place for each research project you undertake in order to cover against two types of possible harm to a research participant, negligent and non-negligent.
Not all projects will need cover against both types of harm. It is the RGIT responsibility to determine what insurance is relevant to your research project.
This insurance assessment should provide you with the reassurance that you have the appropriate level of protection.
Due to certain exclusions in Imperial College policies you must not assume that College insurance will apply to your project until it has been confirmed to you in writing or email by a Research Facilitator.
Where necessary we may need to be referred to the College's Insurance Manager or the College's Insurers for further assessment.
It can be complicated to arrange insurance for overseas research so you will need to contact us as early as possible to discuss this.
You will be required to explain what arrangements are in place for negligent and/or non-negligent harm in any NRES ethics application. We can provide you with a standard statement if required.
NHS Imperial College and Imperial College Healthcare NHS Trust sponsorship process
All healthcare research projects must gain sponsorship approval from the Research Governance and Integrity Team (RGIT) on behalf of Imperial College or Imperial College Healthcare NHS Trust.
Research projects must apply for sponsorship with Imperial College or ICHT whether they are a clinical trial of an IMP or device, human tissue project, observational or epidemiological study.
The RGIT aim to give you a response on registration within 5 working days where possible subject to pressing deadlines of which we are made aware.
NHS Imperial College and Imperial College Healthcare NHS Trust sponsorship process
Registering is a simple process for projects in which you require the College or Trust to act as sponsor.
Please complete the following documents and send them to RGIT inbox:
- A copy of the RGIT_SOP_012_Protocol_design_v12.pdf
- A copy of the IRAS form
- And the participant information sheet and consent if applicable: RGIT SOPs
- All study other related documentation i.e. questionnaires
- An Organisational Information Document and Schedule of Events (or SoECAT if NIHR adopted) for sites outside of ICHT
The RGI team will register the project and advise you on research governance issues if needed. We are happy to arrange to meet with you at your office or laboratory if you would find this helpful.
The RGI team will also do the following (as necessary) for your particular project:
-
Assess for Imperial College or Trust Sponsorship
If you want Imperial to act as the research sponsor, the RGI team will risk assess your project and make a decision on sponsorship.
The RGI Team will confirm Imperial College or Trust sponsorship to you by email with a scanned letter and insurance confirmation if applicable. You must not assume that Imperial College will sponsor your project until you have received this confirmation.
The facilitators will also review the IRAS form, protocol, participant information sheet and consent form for you to ensure that these meet all ethical and regulatory requirements.
2. Assess and confirm insurance cover.
It is extremely important that appropriate insurance is in place for each research project you undertake in order to cover against two types of possible harm to a research participant, negligent and non-negligent.
Not all projects will need cover against both types of harm. It is the RGIT responsibility to determine what insurance is relevant to your research project.
This insurance assessment should provide you with the reassurance that you have the appropriate level of protection.
Due to certain exclusions in Imperial College policies you must not assume that College insurance will apply to your project until it has been confirmed to you in writing or email by a Research Facilitator.
Where necessary we may need to be referred to the College's Insurance Manager or the College's Insurers for further assessment.
It can be complicated to arrange insurance for overseas research so you will need to contact us as early as possible to discuss this.
You will be required to explain what arrangements are in place for negligent and/or non-negligent harm in any ethics application. We can provide you with a standard statement if required.