India is reportedly poised to introduce controlled human infection model (CHIM) studies, a research method in which healthy people are infected with a selected strain of an infectious virus or bacteria in order to test a vaccine, and reduce vaccine development time and costs. Ethical concerns have been expressed about this technology and its introduction in a country with a history of unethical and harmful research and poor regulation.

Vaccines are an important public health intervention. Yet, only 62 per cent of all children under five received full immunisation for 2015-16, according to Health Ministry data, reflecting just a marginal increase over the last decade.

To tackle this, the government needs to strengthen health services. Instead, newer vaccines, with potential commercial interests, are promoted relentlessly as cost-effective solutions. A strong general public health service is an effective bulwark against diseases and the government should be providing it to meet the basic human right to health and healthcare.

More than an upset stomach

Contrary to some public perceptions, participation in a CHIM study is more than getting a cold or mild fever or an upset stomach. While all research participants face a risk of harm and researchers are ethically obliged to minimise this risk, harm is not a risk but a certainty in CHIM studies. Studies in developed countries are conducted in highly controlled settings to minimise the risk of serious harm.

Still, participants even in developed country settings report serious adverse effects. A UK participant infected with typhoid disease called it the worst experience of his life. Other serious adverse effects reported have included heart damage and reactive arthritis.

If CHIM is allowed in India, we can expect many more such reports here — but only if such injuries are identified, recorded and reported. There is no standardised reporting of a “serious adverse event” in a CHIM study nor adequate laws for a new untried and risky model of vaccine trial. In fact, internationally, there are many unknowns about these studies, with no transparency on their conduct, nor public sharing of their data. Human infection studies internationally are operating outside all public scrutiny. India’s regulatory system is even more opaque.

Will people be induced to be harmed? Participants even in developed countries are known to join multiple trials for the high payments, despite the discomfort and the risks posed by repeated infections. Even the low payments in poor countries have motivated potential subjects in CHIM studies to withhold health information that would disqualify them from the trial, putting themselves in greater harm. The same is likely to be true in India where the poor are known to enter studies not for altruism but for healthcare, better healthcare services for themselves — or for money.

Need for public debate

While new vaccines will be necessary, decision making on vaccine research must be transparent and include civil society as well as scientists and policymakers.

However, the government is moving with secrecy, to avoid public debate and opposition. We learn that guidance documents are being drafted and the government is meeting with international health regulators and the World Health Organization to discuss plans for CHIM studies in India.

It would be interesting to know how the decision was made to undertake CHIM trials in India. Has Parliament or any of its standing committees debated this? Who are the members of the committee drafting ethical guidelines and regulations specific to CHIM trials, and what are their affiliations?

More transparency is required on the research and civil society institutions involved to ensure the “controlled environment” in which such studies are to be conducted, and for which vaccines? What if the harm to the participant is irreversible? Have special compensation mechanisms been developed for injury in this research method? Who are the potential participants for such trials? Who are the industry collaborators? Who are the funders? Who will own patents obtained through CHIM? What are the plans for making this research and research methodology public?

There are many ethical and scientific questions that need answers. India is not ready for CHIM studies. Yet their introduction is being presented as a fait accompli. There is a need for a public debate.

Veena Johari is with Courtyard Attorneys, Mumbai; Sandhya Srinivasan is with the Indian Journal of Medical Ethics, Mumbai, and Sourirajan Srinivasan is co-convenor, All-India Drug Action Network, Vadodara. Views are those of the writers