Is ‘new normal’ really a return to the old ways?

Poverty. Inequality. Precarity. Vulnerability. These are mere words, until they hit us directly or confront us in a way which makes it difficult to look away.

A flood of images of migrant workers walking down national highways burst into middle class India’s living rooms following the nationwide lockdown announced by Prime Minister Narendra Modi in March last year. The lockdown came into effect with barely four hours’ notice. All economic activity came to a grinding halt; and there was no transport.

Those searing images of migrant workers —men and women reduced to collateral damage for the State in its battle against the coronavirus — jolted many people.

Suddenly, everyone was talking about the heartbreaking conditions in which all daily wage earners — the face of the country’s vast informal sector — lived and worked.

For a fleeting while, optimists wondered if the Covid-19 pandemic had sledgehammered some fundamental lessons about the need for solidarity between the “formal” and ‘informal’ sectors, if not for anything else but enlightened self-interest.

Almost a year down the line, as we get ready for the vaccine rollout and for the economy to recover fully, what really has changed?

Are we trying to do science and fix the economy in a way that factors in the needs and rights of our most vulnerable? Or is our “new normal” really going back to the old ways?

Last week, once again, images of precarity and poverty came together through the testimonies of desperately poor people who had volunteered to participate in the ongoing clinical trial of Bharat Biotech’s Covid-19 vaccine candidate, Covaxin, in Bhopal.

Covaxin, as everyone knows by now, has been cleared by India’s drugs controller for restricted emergency use. This means, along with Covishield, the Serum Institute of India's coronavirus vaccine, it is part of the vaccine rollout.

Hyderabad-based Bharat Biotech has given safety and immunogenicity data. But there is no efficacy data yet. This data is expected in a couple of months.

Meanwhile, the ongoing trial has attracted a lot of public attention after the allegations of irregularities and violations of ethics. Many questions are being asked about the manner in which People’s Hospital in Bhopal, one of the trial sites, enrolled participants for the Covaxin trial.

Once again, we are face to face with stark images of vulnerability.

The video testimonies arranged by a Bhopalbased human rights group in the wake of the death of a participant in the trial made it clear that those who had signed up to participate in the trial had little idea of what it entailed. Bharat Biotech says the post-mortem analysis has revealed that the death was not related to the vaccine. The family of the deceased feel differently.

Most of those who offered their testimonies on camera are victims of the horrific Bhopal gas tragedy, the world’s largest industrial disaster in December 1984; and many said that they could not read or write.

What leaps out from among the many statements they made is the stark reality of “informed consent” when it comes to poor people with no education and little bargaining power.

As is widely known, there are four key parts of informed consent in a clinical trial — information, comprehension, voluntariness and documentation. “Giving information does not mean it has been comprehended. According to the new clinical trial rules in India, there should be an ‘impartial witness’ while informed consent is being taken from an illiterate participant,” says Dr Anant Bhan, a wellknown researcher in global health and bioethics.

Additionally, for vulnerable participants, there is a requirement for audiovisual documentation of the process, Dr Bhan points out.

“The recent testimonies of volunteers, many of whom are illiterate and poor, for a Covaxin trial site in Bhopal, show big gaps in oversight in the regulatory process,” he adds.

Doing science must not mean playing with the basic human rights of vulnerable people, says Dr Bhan emphatically. Clearly, this is in no one’s interest and will also raise questions on the quality of data coming out of such trials.

“The seriousness of the allegations made by some volunteers in public in full view of the national media raises a question about whether audiovisual recordings of the informed consent process were done in line with the protocol laid down by the Central Drugs Standard Control Organisation (CDSCO),” says Amar Jesani, another leading expert on ethics, rights and health systems and editor, Indian Journal of Medical Ethics.

“This is not filming a wedding party,” says Jesani acerbically. “There is a specific protocol on how these situations need to be filmed. Many of the volunteers are from highly vulnerable groups who did not know their rights. But just because someone does not know his/her rights does not mean rights don’t exist.”

There are many legitimate questions. Do audiovisual recordings of the informed consent process exist for all trial participants from vulnerable groups? Or was it done for only a few? Why?

“This also raises questions about the role of the local ethics committees. Have they investigated whether the audio-visual recordings were done and according to protocol? if such video recordings exist, they can be made public by blanking the face and identity of participants who have not on their own publicly identified as participants,” Jesani adds.

The face of vulnerability is equally stark when it comes to the green shoots of economic recovery.

“There are reasons to fear that economic recovery from the pandemic, like the ‘growth story’, will be shouldered by precarious labour. An already deep employment crisis is worsening further,” wrote SOAS academic Dr Subir Sinha in a recent essay in Open Democracy, a website covering international affairs.

So, is there any reason for hope?

Mukta Naik, an architect and urban planner working with the Centre for Policy Research, acknowledges that many informal workers face “worse terms” as the Indian economy seeks to recover. The images of the long march of migrant workers, she says, sensitised many among India’s middle class, but sadly, the lockdown months made them retreat into their individual bubbles.

However, she points out, many states are now talking about social protection for the vulnerable. There is an appetite for discussion on the subject.

But pathways and mechanisms to operationalise this vision are still not clear, Ms Naik says.

That much-needed clarity could make all the difference.

India doesn’t have to let millions lead a precarious existence. It could use its resources to build back better.

What leaps out from among the many statements in the Bhopal Covaxin trial is the stark reality of ‘informed consent’ when it comes to poor people with no education and little bargaining power

The writer focuses on development issues in India and emerging economies. She can be reached at patralekha.chatterjee@gmail.com.