IIT-Madras under scanner for making school students participate in product test without telling parents

The test took place on August 19. According to parents, students were made to wear a “smart insole” inside their shoes and a smartwatch. They were asked to walk and jump short distances while data was collected. Parents allege they were not informed about the test.

The school is run by IIT-Madras and operates on the institute’s premises. After complaints to the IIT-Madras management and the director K Kamakoti allegedly went unanswered, parents filed a complaint with the State Human Rights Commission (SHRC), alleging that the test violated rules under the New Drugs and Clinical Trials Rules, 2019, and the Drugs and Cosmetics Act, 1940.

The SHRC member, V Kannadasan, told The Indian Express that he received complaints alleging that clinical product trials were conducted without the parents’ consent. “The latest complaint talks about certain invasive aspects of the trial process. We have already demanded a reply from the state school education director,” Kannadasan said.

IIT Madras, however, issued a statement denying that clinical trials or medical device testing had taken place. It said the activity was a feasibility study to test the potential of a cost-effective smart insole assembled from commercially available components. They claimed that the study lasted less than ten minutes per student and involved no invasive procedures or administration of substances. The institute said the insole did not make direct contact with the students’ bodies.

A communication from the school’s managing committee to parents said no stimulants, invasive procedures, or harmful actions had been part of the study. It also said there were no implications for the students’ health but advised that parental consent must be obtained for future activities.

Sources in IIT-Madras claim the process was all about assessing the walking ease with the insole and data was collected using a smartwatch, and argue that the activity did not fall under the category of clinical trials and therefore did not require parental consent.

“A fact-finding committee was formed by IIT-Madras to investigate the incident. The committee found that the faculty did not seek prior approval from parents. It found that while the study did not involve medical or clinical procedures, the protocol had not been followed,” the official source said.

Based on the findings, IIT-Madras replaced the school principal, M Sathishkumar, and issued warnings to the faculty involved. The study was stopped the same day it began, August 19.