What is covered?
The insurance for all UCL sponsored studies is provided by a commercial insurer. The insurance policy provides two types of cover for all studies:
- Cover for claims against UCL for negligence by research participants and others
- Cover for non-negligent harm to study participants, that is compensation to participants where negligence cannot be, or is not proven.
A note summarising the terms and conditions of the policy and a cover note is available from firstname.lastname@example.org
Studies where the insurer needs to be notified before cover is provided
For the majority of studies - CTIMPS and non-CTIMPs, cover is automatic, and we are required only to provide the insurer with a list of all studies covered by the policy. However, for a minority of studies, in certain categories, the insurer requires prior notifications before cover can be provided. These are
- Trials which aim to enrol pregnant women
- Trials where subjects are under 5 at the time of entry to the study and the aim is prophylaxis (treatment given or action taken to prevent disease)
- Studies which enrol more than 5000 subjects
- Studies with international sites (outside of the UK)
- Studies involving a gene therapy medicinal product
These types of studies will only be covered with the approval of the insurers. In addition, special insurance arrangements may be required for participatory sites in CTIMPs or device trials outside the UK. Where studies are referred to the insurer, the insurer may:
- Decide that the study can go ahead with no further conditions
- Decide that the study can go ahead with the provision of an additional payment
- Refuse to provide cover.
All UCL sponsored studies must complete an insurance form. The purpose is to identify those studies where cover is not automatic and where the insurer's approval is required before sponsorship can be agreed.
If the insurer's approval is required and agreed, a confirmatory email will be sent by the insurer.
Who to contact
The UCL and UCLH Joint Research Office administers the insurance form on behalf of UCL for all UCL sponsored clinical research studies managed by the JRO.