Covid-19: Indian health officials defend approval of vaccineBMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n52 (Published 07 January 2021) Cite this as: BMJ 2021;372:n52
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Indian COVID-19 vaccine trials have become further mired in controversy relating to alleged violations of ethical principles at the People’s College of Medical Sciences and Research Centre, Bhopal. When the death of a participant came to light through the media rather than the regulator and sponsors, broader concerns quickly emerged as to the conduct of the study. These included recruitment of vulnerable people with medical problems related to the 1984 gas disaster; questions over adequacy of informed consent; financial inducement to participate; lack of documentation; failure to monitor trial participants.
Bhopal based civil society organisations have called for an immediate end to the trial for Bharat Biotech’s COVAXIN; a full and independent investigation of the concerns; responsible parties to be punished if found negligent; officers of the institutional ethics committee to be held accountable; an audit of scientific and ethical standards in the Research Centre; data gathered so far to be excluded from the trial analysis; access to free medical care and compensation for any participants injured; transparency over the death of the participant. Support for these demands is being requested from individuals and organisations, and in particular from those with a medical background (email email@example.com for details).
Bhuyan A. India's COVID-19 Vaccine Trial Participants Claim They Were Misled. IndiaSpend 2021 Jan 12.
Competing interests: No competing interests