Group of activists raise ethical, safety concerns about ICMR document on Controlled Human Infection Studies

Activists call for public discussion on CHIS, seek clarity on legal issues, compensation.

Before embarking upon controlled human infection studies, the government must ensure that there is a public discussion with regard to this, and must also ensure that people are protected against unfortunate results, a group of activists has said.   

The group that includes an advocate, an independent journalist, an independent researcher and other activists, submitted its comments on the Controlled Human Infection Studies (CHIS) consensus policy statement that the Indian Council of Medical Research (ICMR) has released recently.  

In a 15-page statement, group has also said that the the proposed guidelines or statements must offer opportunities to all people to air their views on this subject. It has called for providing of the names of the individuals who drafted the CHIS document, a list of those consulted, and a list of the reviewers.  The ICMR statement on CHIS is vague, and “allows loopholes, and leeway for legal and ethical violations,” the document said.  

The group has sought to know how CHIS can take place when laws such as the Madras Public Health (Amendment) Act 1958, state that any act performed with a deliberate intention to cause an infection, is illegal. A CHIS may be in direct contravention of Acts such as this one, the group has pointed out. 

The group has also given suggestions, and expressed reservations about various issues regarding clinical trials with healthy individuals and the introduction of disease-causing pathogens in them.  

It has also called for gender inclusive language and definitions of terms used. It calls for information on the capacity, effectiveness and efficiency of current regulatory mechanisms for clinical trials. It has also called for the publication of all results of CHIS – including of failed CHIS, and negative results. These publications must include a clear estimation of adverse events and harms, it said.  

The group has demanded a specific assurance of compensations in case a person is adversely injured during the trial. All those involved in the research should be accountable for adverse events, the group has said.