The majority of research which requires human volunteers involves a degree of risk, and so it is essential that specialist insurance arrangements are in place.
The review board or ethics committee will often require proof of insurance before allowing a trial to start and, 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 can cause costly delays.
Events which can lead to claims include:
• Trial participants being harmed – sometimes seriously
• Participants (or their dependants) demanding compensation
• Participants rejecting the compensation ‘rulebook’ and suing independently for increased damages
How we can help you
We have extensive expertise in arranging Clinical Trials insurance in the UK and around the world and we have access to a specialist panel of expert insurers.
We will conduct all the negotiations on your behalf to get you the best possible solution.
What will we need from you?
• The Protocol Document, which acts as the trial plan, and includes details such as:
– Trial participants – how many, ages, genders etc. Trials involving vulnerable groups such as children and women of child-bearing age will come under particular scrutiny.
– Location(s) of the trial
– Informed consent documents – description of the purpose of the trial, its potential risks and benefits, procedures and duration 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
What cover does clinical trial insurance provide?
Clinical Trial Liability Insurance provides protection in two ways:
1 . Negligent harm to trial participants: caused as a result of lack of due diligence/care or negligence by the sponsor, investigator or CRO. The policy pays for legal costs & expenses and compensation or “damages” awarded to the participant.
2 . Non-negligent harm / “no-fault” compensation: harm to participants of clinical trials with no identified cause, but likely to have arisen from their involvement in the research. The policy pays compensation in line with guidelines set out by competent authorities, such as the Association of British Pharmaceutical Industries.
How can I reduce my clinical trials risk exposure?
Whilst having specialist insurance solutions in place is a key element of your risk management arrangements, you can also protect yourself from liability by focussing on:
• Avoiding conflicts of interest – such as 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