College sponsorship process
All healthcare research projects must be registered with the Joint Research Compliance Office (JRCO).
The project must be registered with the JRCO whether it will be sponsored by Imperial or another organisation (including a commercial company) whether it is a clinical trial of an IMP or device, human tissue project, observational or epidemiological study.
The JRCO aim to give you a response on registration within 5 working days where possible subject to pressing deadlines of which we are made aware.
Registration is required as it allows the JRCO 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 JRCO’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 appropriate Research Governance Manager responsible for your hospital campus or College site:
- A completed insurance registration form
- A copy of the research protocol
- A copy of the ethics application form
- And the participant information sheet and consent if applicable
The Research Faciltators and Research Governance Managers 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 Facilitators 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 Research Facilitators will risk assess your project and make a decision on sponsorship in consultation with the Research Governance Manager.
The Research Facilitator 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 ethics application form, participant information sheet and consent form for you to check for common errors that can slow ethics review.
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 JRCO 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.