Clinical Trial Liability Insurance

Clinical trial liability insurance provides financial protection for those sponsoring and conducting the trials as well as to provide suitable compensation to the volunteers if they are harmed in the process of trial.

Clinical Trial Liability Insurance covers liability arising out of personal damages, material damages and damages arising from breaches of data protection. It also covers the cost of expert evaluations and reports, legal court, arbitration, and commission costs.

Clinical Trial offers protection in two ways:

• Negligent Harm: This offers compensation in case a research subject is harmed due to negligence from the researcher or institute.
• Non- negligent Harm: This covers the unintentional physical damage caused to the research subject.

Normally, both defense costs and claims are payable under the policy up to the policy limits. The sum insured depends upon a number of things, including the size of the trial being conducted, the trial phase, the financial strength of the company conducting the trial, the type of drug or device to be tested, and the location where the trial will be conducted.

Some common exclusions of Clinical trial insurance are:

• Genetic damage
• If the claimant already had a medical condition that led to the physical injury during the medical test
• If the research subject deliberately does not follow the instructions provided during the experiment
• Bodily injury as a result of addiction; even though the addiction developed as a result of the test
• Compensation for immaterial damages like pain and sufferings

Some of the companies offering clinical trial insurance in India are:

• Tata AIG
• SBI General
• ICICI Lombard
• Bajaj Allianz.