For better treatment and medication, clinical trials are an important procedure. However, this trial on human beings involve a lot of risk. To get protection from these risks, the organisations conducting the experiment can go for an insurance in the form of clinical trial insurance.
What is Clinical Trial Insurance?
Clinical trial insurance is an important section of the liability insurance. This insurance plan offers protection against legal liabilities which
result from clinical trials. Clinical trials refer to scientific tests and treatments experimented on people to understand the efficacy of a medicine or medication. A clinical trial insurance covers physical injury, loss of data or property which occurs during the trial.
Types of Clinical Trial Insurance
Clinical Trial offers protection in two ways:
- Negligent Harm: This is a special policy which offers compensation in case a research subject is harmed due to negligence from the researcher or institute.
- Non- negligent Harm: This is the general insurance policy which covers unintentional physical damage caused to the research subject.
What all Clinical Trial Insurance Covers?
This insurance policy should be one of the first things a research institute should look for. The policy comes with the following coverage:
- Personal damage: All forms of compensatory, monetary and statutory compensation caused due to physical injury or illness of the participants. These physical issues should be a cause of the medical tests
- Material damage: This refers to the damage caused to equipment during the clinical trial
- Data breach: This refers to the expenses associated with the data breach. The data loss must be related to the clinical trial
- Extended period offering: This refers to the time period after the policy period has expired. It might happen that the insured receives a claim after the policy has expired for a trial which took place within the policy period. The insurance companies pay for such claims
- Cross liability: This refers to coverage of more than one insured candidate; the total liability amount remains the same
How Clinical Trial Insurance Functions?
Let us understand how clinical trial insurance functions to know it better:
- Fill up a proposal form
- Provide the research details and the number of trials which will be carried out within the policy period
- The insurance company checks the details and approves the policy
- In case of an eventuality, the claimant contacts the insurer
- The documents required for claim settlement are submitted to the insurance company
- An investigator from the insurance company checks the medical reports and submits a draft of the complete investigation to the company
- The trial subject is interviewed by the insurance company to know the extent of illness. It is also verified whether the physical injury is a pre-medical condition
- If the claim is authentic, the amount is transferred to the beneficiary account, else it is rejected
- The insured has the right to raise a case in the court of law, if he/she is not fine with the resolution
Clinical Trial Insurance Claim Process
The financial institutes ensure that the claim is processed in minimal amount of time. Few steps which are followed in processing clinical trial insurance are:
- Keep well ordered records of the all the trials carried out during the policy period
- The claim must be made in written format within the insurance period
- The underwriters must be notified about the claim within 30 days after the policy has expired
- The claim can be made after the first claim is received from one claimant or from several claimants as a result of some unpleasant event which occurred in the clinical trial
- After the claim is made, an officer from the insurance company verifies the same
- If the clam is valid, the compensation amount is paid to the beneficiary account; else it is rejected
- If the claimant is not happy with the resolution, he/she can raise a case in the court of law
Documents Required for Claim Process
The clinical trial insurance claim processing requires the following documents:
- Duly filled in claim form
- Draft of personal damage
- Evidence to ascertain the facts
- Medical report of the physical injury
- Post-mortem report in case there is a death due to the trial
How Long Does it Take to Pay Out a Claim?
Insurance companies usually take 30 days to settle clinical trial insurance.
Cases Where You Can’t Claim Clinical Trial Insurance (Exclusions)
Clinical trial policies do not cover liability for the following damages caused by the test:
- Genetic damage
- If the claimant already had a medical condition which 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
- Expenses which arise due to unwanted pregnancy or incorrect conception of the insured clinical trial
- Damage costs will exclude any offset, return, fees, charges or commissions which the company has already agreed to pay to the research subject
- Compensation for immaterial damages like pain and sufferings
- Punitive or exemplary damage determined by foreign law
Companies offering Clinical Trial Insurance in India
Some of the companies offering clinical trial insurance in India are:
- Raheja QBE
- SBI General
- ICICI Lombard
- Bajaj Allianz.
While applying for a clinical trial insurance, below facts should be kept in mind:
- Claim should always be in a written format
- Clinical trial should comply with the Indian legislation related to drugs
- The insurance company will provide sum insured till the indemnity limit as mentioned in the policy schedule
- The insurance company is liable to pay only till the limit of liability mentioned in the insurance policy. It should not exceed the limit of liability which also includes the defence costs
Advantages of Buying Clinical Trial Insurance
Some of the advantages of purchasing clinical trial insurance are:
- It compensates for all bodily injuries resulting from one occurrence during the insurance period
- The claim can be offered over the insurance period if the beneficiary feels that the claims will be made against the business at some future date
- It covers the legal fee of lawyers. Businesses usually engage independent lawyers to come to an agreement in the compensation amount with the claimant
Q1. What is the sum insured in clinical trial?
The beneficiary is insured against all sums in excess of the deductibles which he/she needs to pay as compensation for damage, claimant costs and expenses which result from physical injury caused by the clinical trial.
Q2. How is the premium for clinical trial calculated?
The premium amount depends on the number of trials which will take place within the policy period.
Q3. What is Limit of Liability in clinical trial insurance?
This is the maximum amount that the insurance company is liable to pay in respect of a single or multiple claim.
Q4. Can the policy holder cancel the clinical trial insurance?
Yes. The insured can ask to cancel the policy by giving a 30-day notice. Some amount of premium will be withheld by the insurance company which depends on the time period within which the policy was effective.
Q5. Can the insurance company cancel the policy?
Yes, the company can cancel the policy by giving a 30-day notice.
Q6. What protocol should be followed in a clinical trial?
Tolerance, pharmaceutical safety, efficacy and efficiency of the medicines, sponsor protocol number, site address of the research centre are some of the protocols to be maintained.