Transparency Tensions: The Missing Data on Rotavirus Vaccine Trial

The CIC criticized the ICMR for not maintaining detailed participant data from a rotavirus vaccine trial. Despite the RTI request by activist Amrita Johri, essential trial statistics, including adverse events, remain undisclosed. The ICMR is tasked with locating or confirming the non-availability of these records.

The Central Information Commission (CIC) has criticized the Indian Council of Medical Research (ICMR) over its lack of transparency concerning a rotavirus vaccine trial. According to the CIC, participant-level data from the trial is missing, despite a Right to Information (RTI) request seeking these details.

The case was brought forward by RTI activist Amrita Johri, who sought statistical information from a trial of the 116E strain of rotavirus, focusing on cases of intussusception. The lack of response from both the Central Public Information Officer and the First Appellate Authority within the stipulated time prompted the CIC to express displeasure over the handling of the RTI request.

The ICMR has been instructed to conduct a thorough search for the essential data. If the records remain untraceable, they are to provide an affidavit confirming their non-availability. Johri emphasized the importance of disclosing such information due to its significant public health implications.