Although one may like to believe that parents/legal guardians would always make the decision that is in the best interest of their children/relative, the possibility of compensation distorting their decision cannot be ruled out. However, many debate that parents/legal guardians incur animal study costs for making it possible for the subjects to participate and therefore they should be rewarded and supported financially.[3] Efforts could be made in offering options that will make the task of such patients?? care takers?Cparents/legal guardians easier and relieve their burden of caring for these patients. For the poor, illiterate and the unaware, monetary inducements can easily be enticing. Poverty and illiteracy are known to coexist.

[6] In this situation, they are unable to comprehend the research information provided in the informed consent document but they do clearly understand the importance of monetary benefits and their utility in their lives. They may pay less attention to the risks involved and participate in the study only for the monetary benefits. Although they cannot be excluded from trial population as they represent a certain group of the society and contribute to generalizability of the research findings,[6] their inclusion should be carefully evaluated and also, whenever their inclusion is necessary, a cap could be placed on the number of subjects that can be included from these populations so that they do not constitute the entire target subject population. COMPENSATION IN DISCUSSIONS IN THE MEDIA Compensation is one of the most talked about topic in the media in recent times.

In the recent past, the parliamentary standing committee was appointed by the Ministry of Health and Family Welfare to evaluate the functioning of the Central Drug Brefeldin_A Standard Control Organization (CDSCO). The reports suggested that in 2010, currently 668 cases of serious adverse events (SAEs) were reported, of which 22 were related to clinical trials; in 2011, 16 cases of the 438 reported SAEs were research related.[7,8] The committee observed that no compensation was paid for these cases. The respective sponsors were asked to pay the compensation for all of the study-related death cases.[7,8] Following this, there have been many discussions over the regulations regarding compensation to research participants. The CDSCO has issued draft guidelines for compensation in case of injury or death during the clinical trial[9] and guidelines for determining the quantum of financial compensation to be paid in case of clinical trial-related injury or death.[10] There have been certain criticisms regarding these draft guidelines.[11?C13] Expert groups of all stake holders have been formed to deliberate and provide suggestions to the ministry on these guidelines.