IIT M researchers’ experiment leads to complaints of unauthorised ‘clinical trials’

Preliminary study at IIT Madras' Vana Vani School raises concerns over unauthorized clinical trials on students.

A preliminary study on students at Vana Vani School inside the Indian Institute of Technology Madras has put the institute in a spot after a parent complained to the State Human Rights Commission.  

According to the complaint, a section of students at the matriculation higher secondary school underwent clinical trials violating the New Drugs and Clinical Trials Rules 2019 and the Drugs and Cosmetics Act, 1940. The tests were conducted by IIT Madras authorities “without prior permission from their parents”, one of the parents wrote to the institute officials. 

It is understood that in a letter the secretary of Vana Vani Matriculation Higher Secondary School’s managing committee admitted that students were part of trials on August 19. The complainant then approached the SHRC. 

A statement from the institute on Wednesday said, IIT Madras administration had constituted a fact-finding committee to ascertain the facts.  

The statement said a preliminary study was conducted on August 19 at the school “to understand the feasibility of a cost-effective smart insole assembled using commercially available items. Neither clinical trials nor any medical-related device trials were conducted. Neither medicine nor stimulants were given. The assembled smart insole was placed inside the students’ shoes to study the ease of walking (the study lasted less than 10 minutes for each student), which had no contact with the human body. Along with the assembled insole, a commercially assembled smartwatch was used to collect the data separately. According to the faculty, this was just a feasibility test and not a clinical trial, and hence it may not require permission from the parents.” 

The statement further said that “no invasive procedures were performed, and no liquid or solids were administered to any of the students before or during the study”.  

The statement further said the issue was “viewed seriously by the school management, and the principal of the school has been replaced. The faculty of IITM was also warned, and administrative action was taken for not ascertaining that permission from parents was to be obtained before performing the feasibility study. The feasibility study was immediately stopped on the same day on 19.08.2024.”