What is a Clinical Trial?
It’s a medical research study that seeks a better way to treat a human disease. Trials are required to establish the safety and efficacy of a new drug, vaccine, medical device or procedure. Because trials are conducted on human volunteers, rigorous controls and procedures must be in place to ensure the wellbeing of the participants. The developer or “sponsor” may conduct the trial themselves or engage a Clinical Investigator or CRO (Contract Research Organisation) to do it for them.
Why is insurance required?
Unforeseen risks are inherent in medical research. Specialist 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 insurance is usually a regulatory or contractual requirement.
How does the insurance work?
Clinical Trial Liability Insurance is available from specialist insurers. The policy provides protection in two ways:
What information is needed to obtain a quote?
Insurers will require the following information in order to quote:
- Location(s) of the trial, whether hospital, surgery or lab-based, and any local clinical trials legislation in that country.
- 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.
Remember that THE ethics committee or 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 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:
Suggested further reading:
Heading off a Clinical Trial Liability Lawsuit, Jill Wadlund, Vice President, Chubb & Son.
Annette B, Company Secretary, ICT
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