Human clinical trials insurance

The rules governing insurance of human clinical trials are complex, particularly if multi-site site trials are undertaken in different locations around the world.

However, in broad terms, anyone undertaking a formal human clinical trial is required to carry ‘non-negligence’ liability insurance to cover any potential claims emanating from that trial.

In order to provide quotations it is usual for insurers to request the following:

Confirmation that approval for the trial has been received from the local ethics committee or is in the course of being applied for.

A copy of the trial protocol. If the trial is to be undertaken overseas a copy of the local language protocol and an English translation is required.

A copy of the patient consent form and the patient information sheet, again in English and the local language.

Local rules exist in different territories about the amount of cover that must be arranged and in some territories the policy must be issued by an office of an insurer situated in that country. MFL will administer the arrangement of all such policies.

Unfortunately, given the complexity of these covers it is not possible to arrange such covers on line. Please contact one of the team to obtain bespoke advice surrounding any trials that you are to undertake or request a call back using the link on the right hand side of this page.