New Delhi: The letter from the ICMR director general asking researchers to speed up trials and processes to meet the government’s deadline of August 15 and be the first in the race to launch a vaccine for Covid-19 has attracted widespread criticism and dented the credibility and reputation of the country’s apex research organisation. On Sunday, India’s foremost science academy, the Indian Academy of Sciences, decried the Indian Council of Medical Research’s directive and the August 15 target to launch the vaccine.
“As a body of scientists, including many who are engaged in vaccine development, IASc believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the mind of our citizens,” IASc said. It cautioned that vaccine development required scientifically executed clinical trials and while there was an unquestioned urgent need, any hasty solution may compromise rigorous scientific process and standards.
Renowned public health advocate Mira Shiva of Public Health Movement said, “ICMR has been responsible for developing the National Ethical Guidelines for Biomedical Research, which lay out details of processes regarding informed consent etc. We would like to see the Ethical Guidelines for Clinical Trials being followed. If on one hand instructions are given for fast forwarding clinical trials of the vaccine for August 15 and that it is being monitored at the top most level of the government, the message is clear about the deadline. A line is added that any non-compliance, would be viewed seriously.
With whom does accountability lie if safety and efficacy issues are blindspotted in an attempt to meet the deadline of August 15. Worse would be if on the basis of these fast forward clinical trial results, the vaccine is introduced with the public made passive recipients.” While ICMR tried to defend its DG’s letter by saying it was only meant to cut red tape, it failed to appease the scientific community which said “serious scientific and ethics review processes by designated committees are not red tape”. Scientists, public health advocates and experts have sharply criticised the content of the letter which also sparked fear that in a rush to meet the timeline, authorities may compromise on the vaccine’s safety and efficacy.
“Serious scientific and ethics review processes by designated committees are not red tape. They are part of a research process. You cut them out or browbeat them, then the possibility of irresponsible science, mismanaged risks and violation of integrity will increase,” said Amar Jesani, editor of Indian Journal of Medical Ethics and a public health advocate.
Researchers from across India demanded an apology from ICMR’s DG for issuing a threat and said the body must clarify the basis of selection of institutions for conducting clinical trials as many of them were small nursing homes unfit for such trials. Anant Bhan, a researcher working on bioethics, said in the absence of best practices, the institutions involved would face a reputational risk along with ripple effects on trust in Indian science.