Clinical Trials Liability Insurance

Because clinical trials are conducted on human volunteers, rigorous controls and procedures must be in place to ensure the wellbeing of the participants - often including clinical trials insurance. The developer or “sponsor” may conduct the trial themselves or engage a Clinical Investigator or CRO (Contract Research Organization) to do it for them. The insurance is usually a regulatory or contractual requirement.

What if...

• Unforeseen risks result in participants being harmed - potentially requiring life-long medical care?
• The participants (or their dependents) demand compensation?
• Particpants reject the compensation guideliness and sue you independently for greater damages?

Unforeseen risks are inherent in medical research. Specialist clinicial trials insurance is a vital piece of the jigsaw and is designed to provide financial protection for those conducting clinical trials and to provide compensation for the trial participants in the event they suffer harm.

How can I get a quote for my organization's clinical trial insurance?

Insurance carriers will need the following information in order to quote:

The Protocol Document, which acts as the trial plan and includes details such as:

• Location(s) of the trial, whether hospital, surgery or lab-based
• Trial volunteers (“participants” or “subjects”) – how many, what sex, age etc. Trials involving vulnerable groups such as children and women of child-bearing age will come under particular scrutiny.
• Informed consent documents - describing for the participants the purpose of the study, its risks and potential benefits and its duration, procedures, etc.

The indemnity limit required for liability insurance - often set by the ethics committee or iinstitutional review board.

Details of the investigator or CRO who will conduct the trial.

Remember that the review board will often require proof of insurance before allowing a trial to start. If trials are being conducted overseas, it’s often necessary to produce insurance certificates in the local language. Failure to arrange the insurance in time often results in costly delays.

How does clinical trial insurance work?

Clinical Trial Liability Insurance is available from specialist carriers. The policy provides protection in two ways:

• Negligent harm to trial participants: caused as a result of negligence, lack of due diligence/care on the part of the sponsor, investigator or CRO. The policy pays for legal costs & expenses and compensation or “damages” awarded to the participant.
• Non-negligent harm (or “no-fault” compensation): harm with no specifically identified cause, but likely to have arisen from the participant taking part in the research. Participants in clinical trials will inevitably sometimes suffer non-negligent harm, with the expectation of being compensated despite there having been no negligence on the part of the sponsor or CRO. The policy pays compensation in accordance guidelines set out by competent authorities.

How can I manage my risk exposure in relation to clinical trials?

Insurance is only part of the solution. You can take positive steps towards protecting yourself from liability by keeping a close eye on:

• Avoiding conflicts of interest - for example by reviewing any financial interests the clinical investigators or CRO may have in the drug or device being trialed.
• The qualifications of the investigators and the make-up of institutional review boards
• The ethics of participant recruitment techniques
• The informed consent process
• Trial monitoring