Parents claim they were fooled into giving consent

The mother of an infant, whose death on Friday was blamed on the rotavirus injection, claimed she and her husband were fooled into giving their consent for the clinical trial.

The couple was read out the terms and risks involved with the trial in English, a language they did not understand, Afsana alleged.

On Friday, some mothers at Centre for Health, Research and Development (CHRD) with whom Deccan Herald spoke to, were found unaware of the vaccination their child was to be administered.

Afsana, however, said she was aware that her daughter’s vaccination was part of a trial.

Authorities at CHRD, where the dead infant was vaccinated, said they have followed the protocol by the book.

“The consent of at least two family members of a child is taken. Their signatures are obtained and they are clearly told about the possibility of death or problems recurring, if any,” said R B Goel, office manager at CHRD.

He dismissed as “lies” allegations that the risks were read out in English.
“Everything, including the documents work, is in Hindi. In rare cases where we have someone who can’t speak Hindi, we seek out someone who can speak their language,” said Goel.

Afsana’s family and friends also alleged that the centre lured the parents into risking their daughter’s safety with offers of a mobile phone, a blanket and Rs 500 in cash, all of which the parents had taken.

Goel said all mothers of infants are offered mobile phones to keep in contact with doctors and field workers of the organisation in an emergency. Cash is given to help them cope with the day’s loss of work.

The “benefits” that come with volunteering for clinical trials draw parents in large numbers to the centre, claimed Goel.

“We care for the child for an entire year after birth. Their every medical need is taken care of. Our doctors visit them once every fortnight. In fact, we have spent many lakhs of rupees on some children,” Goel said, adding risks involved are negligible because it is the last phase of the trial.

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