ICMR guidelines, however, say children should not be included in the studies if these can be conducted on adults. “There are certain diseases like jaundice in children, neonatology highline membrane disease, sepsis where inclusion of children becomes mandatory as the diseases involve children,” added Dr Paul.

Once the inclusion criteria of the subjects is reviewed by the ethics committee, the funding agency gets it reviewed by their set of experts which is then followed by funds provided by them. The parents are also brought into the loop for including their children in the trials. “Parents are given a consent form by the ethics committee. A patient information sheet is developed in which study risks are also mentioned. The children are included only when the parents give their written consent,” said Dr Shinjini Bhatnagar of AIIMS.

Dr M K Bhan, head of Department of Biotechnology, said the trials were done in the best possible way. “As many as 1-3 per cent patients always die when the trials are conducted as these are severely ill patients. These are the best trials as 30 per cent reduction in death rate has been seen,” he added.

Said Dr Nikhil Tandon, endocrinologist, AIIMS, a former member secretary of the ethics committee: “Multiple checks and balances are maintained before conducting such trials. All trails are taken up only after having multiple discussions with the ethics committee. The committee checks if the project is ethically correct or not, whether it is to be done. The committee may then suggest some modifications. If a new agent is to be used in the trial, consent by the Drug Controller General of India (DCGI) becomes mandatory. The ethics committee then has an advisory role.”

... contd.