With the majority of research involving human participants there are elements of risk. It is therefore essential that such research has the required approvals and appropriate insurance arrangements in place before it commences.
The insurance for all UCL studies is provided by a commercial insurer. For the majority of studies the cover is automatic. However, for a minority of studies, primarily in areas of clinical research, the insurer requires prior notification of the project before cover can be provided.
Staff or students undertaking the following types of studies will need to complete an insurance form(see → Insurance Form) when applying to the UCL Research Ethics Committee for ethical approval of their project:
- all intervention studies which enrol over 5,000 subjects
- all clinical intervention studies which enrol children aged 5 years and under where the aim is prophylaxis
- all clinical intervention studies where an inclusion criteria is pregnancy *
- any studies conducted in the USA and Canada.
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.
A cover note summarizing the terms and conditions of the UCL Insurance Policy is available from the Administrator of the UCL Research Ethics Committee.
The Joint UCL and UCLH Research Office (JRO) administers the insurance form on behalf of UCL. Completed insurance forms should therefore be sent to the Joint UCL and UCLH Research Office using its → generic email address, and copied to the → Administrator of the UCL Research Ethics Committee.
You should also attach a copy of this form and any related correspondence to your application to the UCL Research Ethics Committee.