Sponsor clinical trials insurance will be required against negligent harm where there is a risk of harm to a patient when the clinical trial is conducted by any authorised individual according to the protocol i.e. the “protocol risk”.

In some cases, a policy for non-negligent harm (no- fault) may be taken out which would cover patient harm that has a causal link to the trial, without evidence of fault by either the sponsor or research site. Although a no-fault policy provides greater coverage, these types of policies are often much more expensive in comparison to policies to just cover the “protocol risk”.

The two main options to source sponsor insurance and indemnity arrangements for international trials are:

• Insurance to cover the protocol risk is taken out by the sponsor/host institution to provide cover for the trial in relevant countries. Depending on the country, this may require the issue of a local policy via a local insurer, which often include a minimum premium charge. In the case of a sponsor insurance, this may be taken out as an addition to a clinical trials policy already held by the sponsor to conduct trials in the UK, as a trial specific policy or covered by a generic insurance policy with worldwide coverage.
• Insurance to cover the protocol risk is taken out by the participating site for the trial carried out in their country. The responsibility for this arrangement of insurance and indemnity would need to be contractually required in the site agreement. It is unlikely that a participating site would be willing to fund a local policy, so it is likely the UK host institution will be required to reimburse this cost.

Research sites who are conducting the clinical trial (usually identification, recruitment and treatment of patients) should be required to have in place insurance or indemnification to cover claims made in relation to harm to participants as a result of negligence of their employees i.e. to cover the “treatment risk”. This type of insurance is normally medical negligence or malpractice insurance. Ordinarily within the UK, this is covered by the NHS Clinical Negligence Scheme however this isn’t the case for international research sites, so the requirement for insurance to cover clinical negligence at international sites should be contractually required within the research site agreement.

Specific limits of insurance for both sponsor and research site insurance may be required by the funder, the sponsor or by local legislation which may affect the overall cost of insurance to cover international recruitment. If it is decided limits are required, these limits should be clearly detailed within the contract with the research site.

The active insurance period will cover any events and consequent claims that occur within that period. The overall period of insurance cover required will depend on the nature of the trial e.g. if the trial is felt to be low risk, and the trial intervention is delivered soon after entry into the trial and the trial has a long follow-up period, active insurance cover may not be required for the full duration of trial follow-up. If an insurer is willing to link to period of active insurance cover to recruitment, this may provide some protection against future insurance costs should there be a need to extend the trial.

Extended reporting period

Claims can be made during the period of active insurance cover. An extended reporting period means claims can be brought for a set amount of time after the active cover has expired, providing the event occurred within the active reporting period. This can sometimes be provided at no additional cost, or may incur a small additional premium. This can be decided up front whether to take this out, or it may be that this is decided upon at the end of a trial using a risk based approach depending on the number of safety events observed within the trial.

Insurance policies covering international recruitment often entail a minimum charge but may also require the number of patients from each country to be specified. A balance should be struck between providing a conservative figure per country (which may require adjusting at future date) and overestimating this figure (which may result in an additional premium cost up front). It should be explored whether there is the option to adjust these numbers dependant on actual recruitment and whether there is the option to recoup any monies if recruitment is vastly below that specified in the policy. It is recommended where possible that insurance policies for international sites are only activated when a sites participation is fully confirmed as to not lose money on insurance that is not required.

The requirement for local site insurance should be clearly detailed within the contract with international research sites. Will any further evidence of local site insurance be required in addition to this? If insurance policy documents are to be collected in, these will most likely be in a different language and therefore may require translating. Other options include creating an insurance declaration proforma to be completed by the local site in English confirming what level of insurance is in place, along with limits if required.

Not all grant funders will take on the additional costs of insurance to cover international recruitment. Where this is to be taken out specifically for one trial (rather than a generic international clinical trials policy), it is recommended that it is reiterated and made clear to the funder that this is a trial specific cost to see if this is possible to have funded. If the trial funder is unable to fund clinical trials insurance for international trials, other options for funding should be identified as this could be a significant amount of funding to source.

Insurance arrangements for the trial are normally detailed within the Patient Information Sheet/Informed consent form, so it is important to ensure this is reflective of the insurance arrangements in the relevant country as this may differ between sites depending on local requirements.