Are the informed consent forms of clinical trials silent on the rights and obligations of participants with respect to their life insurance policies?
Though life insurance in India has poor penetration, it has increased over the last couple of years after the entry of private insurance providers. When a person buys his life insurance, the insurance company carries out the process of underwriting which involves the risk profile assessment of the individual on the basis of information provided, including reports of medical investigations (if done). The policy documents of the majority of insurance providers state that a claim is not allowed in a case of suicide within one year of commencement, or revival, of the policy. In a parallel situation, assume that a person enters a drug trial leading to change in the risk profile. Do our informed consent documents inform insured persons about their rights and obligations? Should the participant inform the insurance company? Can his claim be rejected later if he dies because of the effects of a drug trial? The recently introduced compensation clause and its calculation mechanism may or may not be equivalent to the amount of insurance the individual might have taken (1, 2). Nowadays, due to various market forces, the usual online term plan offers insurance of Rs 1 crore or more at a relatively affordable premium.
Consider a second example, where an individual is part of a clinical trial and applies for an insurance policy. Has his risk profile changed? Is his premium going to be high? Or will he be denied an insurance policy? Is his premium going to be reduced after one year or so when he is out of the clinical trial? Who will compensate for the high premium? The most important issue is: what happens if his policy is declined? Probably after this, the participant will not be able to take any future polices as he needs to mention that earlier he had been denied a policy due to his involvement in a clinical trial and none of the companies will take the risk of providing him with life insurance. Are we going to compensate him for this?
Now consider a third scenario: the person may have been lucky enough to get the policy as he did not inform the insurance company about the clinical trial unintentionally, since the informed consent document is silent on this issue. What happens if the company becomes aware of the facts at the time of the claim, as it will ask for all previous medical records?
In a fourth scenario, a participant with very high insurance due to a terminal illness, like cancer for which no treatment is available, enters a clinical trial. If he dies, it may be difficult to prove he died due to illness during the clinical trial or due to a drug used in the clinical trial. What happens to his insurance policy?
In any of these cases, if the insurance company denies the claim, can family members approach the insurance ombudsman and hope to be considered? Should the insurer never deny any claim if the death occurs more than one year after the policy?
All these are grey areas. As a research community, we need to come forward and design a model informed consent which covers all these issues of importance to the trial participant for the protection and care of his family, in case of his unexpected death.
Pankaj Shah, Professor, Department of Community Medicine, Sri Ramchandra Medical College and Research Institute, Sri Ramchandra University, Porur, Chennai, 600 116, INDIA e-mail: firstname.lastname@example.org