Some believe

Some believe that extra-care is required to be taken in pediatric clinical trials, because it is parents, who are not at any risk of physical injury, provide permission to include their children in the study.[37] In such a situation, compensation amount could act as bait and induce them to overlook the risks involved and use children as a commodity.[1] At the other extreme is the opinion that providing compensation is a must to facilitate enrollment and enhance retention of participants in the trial. For greater clarity, we can classify the compensation for participation into two categories. The first one consists of providing reimbursement of costs of participation in research such as for travel and meals. It is unfair to ask parents and children to bear additional costs resulting from participation in research.

It is, therefore, generally accepted that they should be reimbursed on the basis of actual expenses incurred or a realistic estimate of such expenditure.[1] The second category of compensation can be sub-divided into three types: compensation for time spent in participation, enticements for recruitment and retention; and gifts of appreciation at the completion of the study.[33] A small token gift to the child as a means to say ??thank you?? for participation is not uncommon. The value of the gift could be varied as per the length of time spent in research-related activities. It should never be determined on the basis of level of risk.[1] The American Academy of Pediatrics suggests that if remuneration is to be given directly to the child in research, it GSK-3 is best not discussed until after the study so as not to affect voluntary participation.

[32] Keeping the compensation amount reasonable and minimal will ensure that the participation is voluntary.[22] The regulators have delegated the responsibility of determining the quantum of compensation for participation to the Ethics Committees, since third it is the responsibility of the ECs to ensure that participation in research studies is voluntary, unpressured and not unduly influenced by external factors (such as payment). It is also because the quantum of compensation would be dependent upon the local population characteristics (at times even individual family characteristics), number of visits envisaged in the individual protocols, etc. Thus, it is the prerogative of the ECs determine the quantum, methods and timings of compensation and make sure that these payments would not compromise voluntariness of participation. It must, however, be conceded that this unlimited latitude given to the ECs for determining compensation leads to great variability in practices related to and amounts of compensation approved by the ECs.

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