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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.
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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.
Adverse events
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.
The drug control regulators’ ethical obligations must be specified, and a separate section with “complete details of safety requirements” should be created.
The ICMR statement should describe a “knowledge threshold” so that healthy participants in the drug trial are not exposed to something about which the researchers do not have adequate knowledge, the group’s statement said.
The terms “Deliberate infection” and “Deliberate harm” must be defined and the conceptual difference between the two explained. The “Deliberate harm” in Phase I clinical trials may be different from that in CHIS. The notion of a “permissible” level of harm, how the limit would be set, and by whom must be stated. The possibility of long-term harm in CHIS — the need for monitoring for this, and how this would be factored in for compensation – must be stated, the group has said.
It is necessary to engage with the public to prepare and train the community on safety measures in case of a spread of infection with challenging strains of pathogens, as the statement has mentioned a risk of challenging strains.
The group has also called for detailed explanation of the quantum of compensation, including who will provide the compensation, for those adversely affected during the trial.
