CIC Raps ICMR Over Missing Rotavirus Trial Data, Calls RTI Handling Cavalier, Seeks Affidavit
New Delhi: The Central Information Commission (CIC) pulled up the Indian Council of Medical Research (ICMR) for claiming that participant-level data on a rotavirus vaccine trial is "not maintained".
The ICMR said this in response to an RTI plea seeking statistical details of trial outcomes, including cases of intussusception (a condition where part of the intestine slides into another, causing blockage).
The CIC termed the handling of the RTI plea as "cavalier". It directed the ICMR to conduct a fresh search for the records and file an affidavit confirming their non-availability if they are not found.
The case pertains to an RTI application filed by RTI activist Amrita Johri seeking details of a clinical trial of the 116E strain of rotavirus conducted with government funding and registered with the Clinical Trial Registry of India.
The applicant had sought data on the number of children who received the vaccine and placebo in Vellore, Tamil Nadu, and on cases of intussusception recorded during the two-year study period.
During the hearing, Information Commissioner Jaya Varma Sinha noted that neither the Central Public Information Officer (CPIO) nor the First Appellate Authority had furnished a reply within the stipulated time under the RTI Act.
"The Commission, after adverting to the facts and circumstances of the case, hearing both the parties and perusal of the records, observes that no reply has been given to the Appellant either by the CPIO or by the First Appellate Authority within the stipulated frame as per the provisions of the RTI Act. Therefore, the Commission expresses displeasure at the conduct of both the CPIO and FAA for treating the instant matter in a cavalier manner," the order said.
However, in its written submission, the ICMR said the Clinical Trial Registry-India (CTRI) maintains trial protocols and methodological details but does not hold participant-level data, adding that "the participant's data is not maintained in CTRI and hence the queries are not relevant to CTRI".
Taking note of the contention, the Commission directed the CPIO to make a thorough effort to trace the relevant records and provide the requested statistical information within three weeks, if available.
"On the contrary, if the relevant record is still not found, the CPIO is directed to submit an appropriate affidavit, on non-judicial stamp paper, deposing the factum of non-availability of the relevant record," the Commission said.
Johri told PTI that she had sought details of the trial results, "especially the incidence of the risk of intestine obstruction," but received no response to her RTI application or first appeal.
She said, "The RTI application was filed more than 18 months ago. The ICMR also claimed that they did not maintain this information. In the hearing, it was pointed out that no personal details of the trial participants have been sought, only statistics regarding the results of the study."
She also flagged concerns over transparency, saying such information "should in any case be proactively published since this is an issue of great public interest due to its direct impact on our health".
According to the World Health Organisation (WHO), Rotavirus is the leading cause of severe, dehydrating diarrhoea in children under 5 years old.
