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Published: August 14, 2012 02:23 IST | Updated: August 14, 2012 02:23 IST

Health activists oppose clinical trial compensation guidelines

Aarti Dhar

“Age and income cannot be the lone criteria for calculating the amount”

Health activists have strongly opposed the draft guidelines brought out by the Central Drugs Standard Control Organisation (CDSCO) on the quantum of financial compensation to be paid in case of clinical trial-related injury or death, saying age and income could not be the lone criteria for calculating the amount.

The draft guidelines, put up on the CDSCO website for comments, say that for assessing compensation, the age and income of the deceased and the seriousness and severity of the disease the subject was suffering from at the time of his or her participation in the trial should be taken into consideration. It has also suggested a formula for calculating the amount.

Also, the subject shall be entitled to financial compensation as per the recommendations of the Ethics Committee.

Reacting to the guidelines, S. Srinivasan of LOCOST, a rights-based non-governmental organisation, said it appeared that the old would get lesser compensation than the young; the financially better-off would get more compensation than the poor and that the formula provided lesser compensation to the seriously ill and those suffering disability as a result of the trial, than to the healthy persons who are affected. “Much would also depend on how neutral the Ethics Committees are, that normally is not the case,’’ he said.

Mr. Srinivasan said the guidelines were unfair to subjects below the age of 16 or housewives who had no income. Also, there was no clarity on the procedure to decide the percentage of disability. He said it appeared that healthy subjects would get more compensation than those suffering from some ailment at the time of their agreeing to the trial.

N. Sarojini of Sama said: “For me this notion of income is extremely problematic. What about those who are not working, like children, young students or old people? How do we calculate their stream of income? Similarly, the income can also be flexible; it may increase or decrease, particularly in the context of unorganised sector.”

Pointing out how the principle of compensation could be misused, she said: “The formulae in the guidelines are delinked from responsibility. The compensation, either for injury or death, should be multiple times in cases where the agency conducting the trial is held guilty of misguiding or misinforming people. In situations where the negative intent is established, the compensation principle has to be different. Otherwise, the principle of compensation encourages irresponsible trials.”

The compensation should not be restricted to direct short-term injury during the trial. In many cases, the injury to the research participants is not immediate. At present, there is no specific provision under the Drugs and Cosmetics Rules for payment of compensation in case of clinical trial-related injury or death. However, the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India state that the research subject who suffers physical injury as a result of his participation in clinical trials is entitled to financial or other assistance to compensate him equitably for any temporary or permanent impairment or disability, subject to confirmation from the Ethics Committee. In case of death, the subject’s dependents are entitled to compensation.

Keywords: clinical trial compensation, CDSCO, human clinical trial, medical compensation


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Printable version | Aug 14, 2012 9:42:40 AM |

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