methodology recommended for computing the compensation. We illustrate this by computing the sums to be paid under various assumptions, and then discuss the ethical dilemmas involved.
Formulae for computing compensation
The guidance recommends the following formula for computing compensation for a trial-related death (C1):
C1=A x B(1-F/100)
In this formula, 'A' is 50% of the participant's monthly income; this represents what the participant would be contributing to his/her dependents. If the monthly income is less than what it would be with the legal minimum wage, or if the participant does not have any monthly income, 'A' will consist of the legal minimum wage (calculated monthly).
'B' is a multiplier that is given and varies with the age of the research participant. In this case, age is taken as the age of the research participant at death or disability.
'F' is the seriousness or severity of the participant's disease at the time of recruitment into the trial. The compensation for a participant with a disease is computed as a fraction of what would be due to a healthy individual; for a healthy individual it would be 'A' x 'B' alone.
'F' is to be determined on a scale of 0 to 100, where '0' represents "no deviation from good health" and '100' represents death. The study investigator is required to set the seriousness or severity to this scale, while ensuring that the most serious or severe condition is not set at more than 50%. This means that even for participants for whom death is imminent due to an underlying health condition, the seriousness will not exceed 50%.
To determine compensation for injuries (C2), the guidance suggests the application of a different formula:
C2=A x B(1-F/100) x D/100
Here, 'A' is 60% of the participant's salary, representing the contribution for his/her dependents. 'B' varies with age, as it does in the formula for computing compensation for a participant's death. 'F' is the seriousness or severity of the disease at the time of participation. As the formula estimates the compensation for injuries and not death, another variable, 'D', is included: the percentage of disability caused to the participant due to trial participation. It is not clear how this is to be determined, but perhaps this is left to the ethics committee.
An attempt to mathematically compute the quantum of compensation has the potential to reduce a morally compelling act to one of administrative largesse, with attendant clerical rather than moral responsibility. It would be more advantageous and ethical to provide guidance to IECs on how to make this determination along the lines of what other countries have done (12) and leave the responsibility for determining the exact amount of compensation to them. The guidance could list the various criteria that need to be used and the rationale for these criteria, and the potential for trade-offs across criteria. Some possible criteria would be the extent of handicap in everyday social and professional life experienced by the participant as a result of the disability, the number of dependents and their characteristics, and so on. This would provide the flexibility required to manage the known criteria, and any others that may be recognised by the EC while undertaking this exercise. If such general guidance has served well in the determination of potential risks and benefits (which to this day have not been converted to an exact measurement of a net risk-benefit ratio), it would serve to determine a just compensation for a life lost or disabled. It has the potential to make ECs more meticulous in their engagement with research protocols. In the long run, one hopes that it would serve us to make death or disability due to clinical trial very rare for a participant.www.icbiocro.com
