CIC Slams ICMR for Lack of Data Transparency in Vaccine Trial

The Central Information Commission reprimanded the Indian Council of Medical Research for failure to maintain participant data in a rotavirus vaccine trial. The action followed an RTI petition seeking trial statistics. The CIC demanded exhaustive record searches and an affidavit if records remain unfound.

The Central Information Commission (CIC) has criticized the Indian Council of Medical Research (ICMR) for not maintaining participant-level data from a rotavirus vaccine trial.

Responding to an RTI plea, the ICMR indicated that relevant statistical data, including instances of intussusception, isn't kept. The CIC called the handling of the RTI request 'cavalier' and instructed the ICMR to conduct a fresh records search. If the data remains unavailable, the ICMR must file an affidavit confirming this.

The case emerged from a plea by RTI activist Amrita Johri, aiming to reveal details of a clinical trial for the 116E rotavirus strain. Despite significant public health implications, information on vaccine recipient data and recorded issues during the trial period was not provided in a timely manner.

The World Health Organisation notes that Rotavirus is a leading cause of severe diarrhea in young children, emphasizing the need for transparency.