Many participants of a coronavirus vaccine trial in Madhya Pradesh’s Bhopal city have alleged that they were given the shots without informed consent, NDTV reported on Tuesday. The trials were held at the People’s College of Medical Sciences, a local private hospital.
The news channel reported that it has spoken to many of the trial’s participants, who claim that they were not informed about the trial and its risks and were also not given copies of the consent form, which is mandatory for conducting such trials. The hospital, however, has denied all the allegations.
The hospital is located half a km from areas occupied by the poorest and 1984 gas tragedy-affected communities. The hospital allegedly approached the residents of these areas, including Gareeb Nagar, Oriya Basti, Shankar Nagar and JP Nagar, and offered Rs 750 for the injection. The residents also said vehicles were sent to take them to the site of the trials.
Rekha, a resident of Bhopal’s Oriya Basti, told the news channel that she was not given a consent form or even told about the trial. “I have never got a call from the hospital,” she said. “... the hospital said [if I take if this injection] I won’t get coronavirus.”
Savitri, a resident of Savitri Nagar, alleged that the hospital authorities told her that they were administering a coronavirus vaccine, without mentioning anything about the trial.
According to the statements of some of the trial participants as reported by the news channel, about 250 people signed up. It is alleged that only a few were told about the risks, given consent forms or informed if they would be insured. The hospitals reportedly collected nasal, urine and blood samples after which it gave the participants a four-page booklet to jot down any side effects they have. Many of the participants do not know how to write.
Jitendra Narwaria, a daily wage earner, told the news channel that he signed up because his friend told him that the hospital was conducting blood tests. He claimed that the doctors told him that the shot would cure any blood-related problems.
The hospital, however, has claimed that they followed all the Indian Council of Medical Research guidelines regarding conducting vaccine trials, including giving half-an-hour counseling session where the participants were informed about the doses and potential side effects.
“This information [allegations that participants were not given informed consent forms]... I don’t think is correct,” Dr AK Dixit, the dean of the hospital, told the news channel. “It [their consent] is recorded with us... anybody who asks for the report, we give them. Otherwise, it is with us. Informed consent is always taken.”
Madhya Pradesh Education Minister Vishwas Sarang said that the government would look into the matter. He, however, said people supporting the “tukde tukde gang” were indulging in politics. “Tukde-tukde gang” is a term used to target people the BJP and its supporters allege are out to balkanise India.
“We will definitely look into the cases,” he said. “My feeling is a section of society who wants to scare people is indulging in politics. It is a big issue... our scientists have developed a vaccine and those who are from tukde tukde gang are opposing... those supporting Kanhaiya [Kumar], Pakistan.”
Meanwhile, India on Tuesday registered 16,375 new coronavirus cases, taking its overall count to 1,03,56,844. The country’s toll rose by 201 to 1,49,850. India’s active cases stood at 2,31,036, while the recoveries reached 99,75,958.