Because clinical trials are conducted on human volunteers, strict controls and processes must be in place to ensure the wellbeing of the participants – including clinical trials insurance. The insurance is usually a regulatory or contractual requirement.
If your company is involved in medical research programmes, clinical trials insurance is an essential component of your risk management package. This will provide protection for your participants as well as your business should something go wrong.
Negligent harm to trial subjects
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 subject.
Non-negligent harm (or “no-fault” compensation)
Harm with no specifically identified cause, but likely to have arisen from the subject taking part in the research. Subjects 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, such as the Association of British Pharmaceutical Industries or the equivalent in the country where the trial is taking place.
Whether you’re running mass clinical trials, smaller studies, or just beginning your recruitment, you’ll know that clinical trials can come with significant negligence, malpractice and liability risks.
