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Covid vaccine trials in Bhopal without participants’ informed consent?

Some trial participants were gas tragedy survivors, activist alleges medical malpractice

Sabrangindia 06 Jan 2021

covid vaccine

People in Bhopal were allegedly misled into participating in a Covid vaccine trial in Bhopal, according to an NDTV report. Participants were neither informed that they were participating in a trial, nor told about side-effects. What’s worse, they weren’t even given copies of the consent form, something that is mandatory in all human trials.

A participant told NDTV, “Nobody told me about any side effects and nobody gave me a copy of the informed consent form. Participants were allegedly only told that the injection would prevent Covid. The trials were conducted by People’s College of Medical Sciences.

According to the NDTV investigation people residing in Gareeb Nagar, Shankar Nagar, Oriya Basti and JP Nagar were targeted by hospital staff and offered Rs 750/- each. It is noteworthy that the residents of these neighbourhoods not only hail from extremely impoverished backgrounds, but many of them are also survivors of the Bhopal Gas Tragedy.

These neighbouhoods are located in close proximity of the Union Carbide plant from where poisonous Methyl Isocyanate gas leaked on the intervening night between Dec 2 and 3, 1984. Over 5,00,000 people had been exposed to the gas and over 3,800 people were killed within the first few days of the Bhopal Gas Tragedy. Moreover, close to 20,000 others died subsequently due to gas exposure related health complications. Additionally, 38,000 people suffered temporary or partial disability, while almost 4,000 suffered from permanent disability or health problems.

Activist Rachna Dhingra who works closely with Bhopal Gas Tragedy survivors also raised concerns about the trials in a tweet saying, “3rd Phase #Covaxine trial taking place in Bhopal has violated every rule in d book Poor & vulnerable residents of gas affected communities r herded by d People's  with a promise of Rs750. No copy of informed consent is being given 2 d participants

@CDSCO_INDIA_INF”

 

 

In a series of tweets, Dhingra also alleged, “Participant's 'Informed consent' is not obtained prior to enrollment in d study but after d end of trial. Recvd first shot on 7Dec& second on 4Jan. Consent signed on 4Jan. @CDSCO_INDIA_INF really needs to take cognisance of these violations & intervene”. She tweeted the video statement of Jitendra Narwariya, a trial participant.

 

 

Meanwhile, the hospital’s Dean, Dr. AK Dixit rubbished claims of any malpractice or wrong doing. He told NDTV, that all protocol and trial related rules as laid down by the Indian Council of Medical Research (ICMR) were followed. “This information (allegations that participants were not given informed consent forms)... I don't think is correct. 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,” NDTV quoted Dr Dixit as saying.

Madhya Pradesh Medical Education Minister Vishwas Sarang has said that an investigation will be conducted.

 

Related:

Battling Covid: New vaccines, new concerns

After trial Covaxin shot, Haryana health minister Anil Vij test Covid-19 positive

COVISHIELD vaccine trial participant sues Serum Institute 

Covid vaccine trials in Bhopal without participants’ informed consent?

Some trial participants were gas tragedy survivors, activist alleges medical malpractice

covid vaccine

People in Bhopal were allegedly misled into participating in a Covid vaccine trial in Bhopal, according to an NDTV report. Participants were neither informed that they were participating in a trial, nor told about side-effects. What’s worse, they weren’t even given copies of the consent form, something that is mandatory in all human trials.

A participant told NDTV, “Nobody told me about any side effects and nobody gave me a copy of the informed consent form. Participants were allegedly only told that the injection would prevent Covid. The trials were conducted by People’s College of Medical Sciences.

According to the NDTV investigation people residing in Gareeb Nagar, Shankar Nagar, Oriya Basti and JP Nagar were targeted by hospital staff and offered Rs 750/- each. It is noteworthy that the residents of these neighbourhoods not only hail from extremely impoverished backgrounds, but many of them are also survivors of the Bhopal Gas Tragedy.

These neighbouhoods are located in close proximity of the Union Carbide plant from where poisonous Methyl Isocyanate gas leaked on the intervening night between Dec 2 and 3, 1984. Over 5,00,000 people had been exposed to the gas and over 3,800 people were killed within the first few days of the Bhopal Gas Tragedy. Moreover, close to 20,000 others died subsequently due to gas exposure related health complications. Additionally, 38,000 people suffered temporary or partial disability, while almost 4,000 suffered from permanent disability or health problems.

Activist Rachna Dhingra who works closely with Bhopal Gas Tragedy survivors also raised concerns about the trials in a tweet saying, “3rd Phase #Covaxine trial taking place in Bhopal has violated every rule in d book Poor & vulnerable residents of gas affected communities r herded by d People's  with a promise of Rs750. No copy of informed consent is being given 2 d participants

@CDSCO_INDIA_INF”

 

 

In a series of tweets, Dhingra also alleged, “Participant's 'Informed consent' is not obtained prior to enrollment in d study but after d end of trial. Recvd first shot on 7Dec& second on 4Jan. Consent signed on 4Jan. @CDSCO_INDIA_INF really needs to take cognisance of these violations & intervene”. She tweeted the video statement of Jitendra Narwariya, a trial participant.

 

 

Meanwhile, the hospital’s Dean, Dr. AK Dixit rubbished claims of any malpractice or wrong doing. He told NDTV, that all protocol and trial related rules as laid down by the Indian Council of Medical Research (ICMR) were followed. “This information (allegations that participants were not given informed consent forms)... I don't think is correct. 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,” NDTV quoted Dr Dixit as saying.

Madhya Pradesh Medical Education Minister Vishwas Sarang has said that an investigation will be conducted.

 

Related:

Battling Covid: New vaccines, new concerns

After trial Covaxin shot, Haryana health minister Anil Vij test Covid-19 positive

COVISHIELD vaccine trial participant sues Serum Institute 

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