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What is covered ?
Insurance for UCL sponsored studies is provided by a commercial insurer. For CTIMPS, cover is provided for both negligence harm and non negligence harm. For non CTIMPs, cover for negligence only is routinely provided. Non negligence harm cover can be provided where the Research Ethics Committee requires it.
What should I put on the Ethics Application, Patient Information Sheet and Protocol ?
Information about this can be provided by the Research Co-ordinator responsible for your study.
How does it work ?
For the majority of studies - CTIMPs and non CTIMPs cover is automatic. However, for a minority of studies, the insurer requires notification before cover can be agreed. The studies where notification is required varies from year to year but for 2011/12, the following need to be referred to the insurer (the purpose of the Insurance Form is to identify these studies):
- all intervention studies which enrol children aged 5 years and under where the aim is prophylaxis
- all intervention studies which enrol over 500 subjects
- all intervention studies where an inclusion criteria is pregnancy.
An intervention is:
- a device
- an investigational drug or cellular product
- a procedure which requires entry into a body cavity
- radiation including X-rays
- studies where all interventions are standard of care do not need to be referred.
- radiation including X-rays Studies where all interventions are standard of care do not need to be referred.
What happens if a study is referred ?
The insurer may
- decide the study can go ahead with no further conditions
- decide study can go ahead with an additional payment
- decline to cover the study
In the case of the latter an alternative insurer will be needed and this will result in additional costs. These costs must come from the study budget.
Intending to enrol at sites overseas ?
If you are undertaking an interventional study and intend to enrol at sites outside the UK, then it likely that a 'local' insurance policy will be required. These policies can be expensive and the costs need to be built into any grant application.
For further information
If you have any queries on UCL insurance cover for research studies, please contact: uclh.randd@nhs.net.
