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 click on the Contact
Me link.
