There are many risks in conducting a clinical trial, with the main risk being harm to patients; the majority of sponsors will require some form of insurance to cover this risk. There are also specific requirements under national and international law which require an organisation to have an insurance policy in place. Insurance for clinical trials that are recruiting internationally can result in significant additional costs being incurred, even when a clinical trials insurance policy is held as in the majority of cases, international recruitment will not be covered by a standard UK policy.
Patient harm can be broadly categorised into negligent and non-negligent harm
Negligent Harm: Failure to exercise the care toward others that a reasonable or prudent person would use in the same circumstances, or taking action that such a reasonable person would not, resulting in unintentional harm to another. This might include a lack of due diligence, lack of care, error or omission, breach of duty or an act of carelessness towards a participant in a clinical trial which may arise from:
- An error in the design of the trial or writing of the protocol termed “protocol risk”
- Clinical negligence termed “treatment risk”
Non negligent harm: Circumstances where there is no specifically identified causative factor relating to the harm of a participating, but harm is likely, on the balance of probabilities, to have arisen from the patient taking part in the research.
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 Site Insurance
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.
Limits of Insurance
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.