Unforeseen risks are inherent in medical research. Specialist clinical 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.
The ethics committee or review board will often require proof of insurance before allowing a trial to start – and failure to arrange the insurance in time can result in costly delays.
How does clinical trials liability insurance work?
Clinical trials are conducted on human volunteers, so 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 clinical trial themselves or engage a Clinical Investigator or CRO (Contract Research Organisation) to do it for them. The insurance is usually a regulatory or contractual requirement.
What if your trial results in participants being harmed and potentially requiring life-long medical care? This could lead to the participate (or their dependents) demanding compensation or rejecting the compensation guidelines and suing you independently for greater damages.
Clinical trials liability insurance provides protection in two ways:
- Negligent harm to trial participants: resulting from negligence, lack of due diligence or care on the part of the sponsor, investigator or CRO. The policy pays for legal costs and expenses with compensation or “damages” awarded;
- 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 may sometimes suffer non-negligent harm, and expect compensation even in the absence of negligence on the part of the sponsor or CRO. The policy pays compensation in accordance guidelines set out by competent authorities, such as the Association of British Pharmaceutical Industries.
NB: If trials are being conducted overseas, it’s often necessary to produce insurance certificates in the local language.
Who is this cover for?
Medical Device Developers
Contract Research Organisations (CRO)
We thought that we had exhausted all options for our type of business. They completely understood the field we operated in and provided us with new options – and then shopped around for us to get a better price.
Insurers will require 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, its duration, the procedures, etc.
- The indemnity limit required for liability insurance – often set by the ethics committee (also known as “institutional review boards” in the USA).
- Details of the investigator or CRO who will conduct the trial.
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 trialled.
- The qualifications of the investigators and the make-up of ethics committees or institutional review boards
- The ethics of participant recruitment techniques
- The informed consent process
- Trial monitoring