Clinical Trial Insurance

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.

Why do I need Clinical Trials Insurance?

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.

Clinical trials insurance provides protection in two ways:

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.

Clinical Trials Insurance questions

To get your clinical trial approved by an ethics committee, you will need a clinical trials liability certificate of insurance specific to the territory in which the trial will take place.

The ethics committee or review board will often require proof of insurance before allowing a trial to start. Failure to arrange the insurance in time often results in costly delays or not having the permission granted to conduct the trial.

How can I get a quote for clinical trials insurance?

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 including trial site details
    • Number of Trial volunteers/research subjects
    • Details of the investigator or CRO who will conduct the trial.
  • Informed consent documents – describing for the research subject 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).

With this information FOCUS can provide you with the a solution to suit your needs.