News Excerpt:

This article examines the ethical and financial issues of Controlled Human Infection Studies (CHIS), in which people are purposely infected with disease-causing viruses for research objectives.

About Controlled Human Infection Studies (CHIS)

• Controlled Human Infection studies (CHIS) refers to the research methodology that involves intentionally exposing healthy human volunteers to a specific pathogen or infectious agent under controlled conditions.
• These studies aim to understand disease pathophysiology & immune responses, develop vaccines, test treatment modalities, and evaluate the safety and efficiency of potential New Chemical Entities (NCE).

Regardless of the potential scientific benefits, these studies are ethically sensitive and raise concerns about contentious research ethics – such as issues like deliberate harm, possible disproportionate payment and hence inducements, third-party risk, withdrawal from the study and research with vulnerable participants.

Key highlights from the CHIS study:

• As per Jake D Eberts, Communications Director at 1Day Sooner, If someone joins a CHIS for the money, as long as they understand the risks, that’s not inherently bad.
• Imposing a ceiling on compensation does not protect low-income people. 
• What protects low-income people (and everyone) is an informed consent process and an ethics review process that makes sure of the risks of the study.
• According to research, remuneration should not be used to persuade individuals to take risks they would not otherwise accept.
• It also stated an ethical remuneration framework based on a Wage-Payment Model that takes into account the time, activities, and dangers involved.
• As per Paul Zimmer-Harwood from 1Day Sooner, in the U.K., it is a strict guideline that compensation should not incentivize risk-taking behaviour but should instead be commensurate with the time and commitment a participant invests in the study.

View of ICMR on CHIS payment:

The ICMR’s (Indian Council of Medical Research) Bioethics Unit, which introduced a consensus policy statement on CHIS, mentions that payment should take into account the loss of wages and the time spent and efforts made while participating in CHIS. But it has made altruism central to participation.

The need for CHIS in India

India carries a high burden of morbidity and mortality from infectious diseases. Infectious disease  contributes about 30% of the disease burden in the country. Finding novel, efficient, and cost-effective alternatives to existing methods of research in these diseases and their prevention are imperative to reduce this burden. 

• CHIS is a relatively new research model that helps provide unique insights into disease pathogenesis and can accelerate the development of novel medical interventions.
• CHIS can improve understanding of specific aspects of the transmission patterns and/or excretion and/or secretion patterns and dynamics that contribute to the development of effective public health strategies and policies.