Welcome happening: Robust institutional mechanisms must be in place for human challenge studies

Source: The post is based on the article “Welcome happening: Robust institutional mechanisms must be in place for human challenge studies” published in “The Hindu” on 26th July 2023.

Syllabus: GS2- Issues relating to development and management of Social Sector/Services relating to Health, Education & GS4- compassion towards the weaker-sections.

News: The author discusses the need for strong institutional mechanisms and ethical considerations before conducting human challenge studies (CHIS) in India.

What are Human Challenge Studies (CHIS)?

Definition of CHIS: Human Challenge Studies (CHIS) involve intentionally exposing healthy volunteers to disease-causing microbes in a controlled environment for research purposes.

Purpose of CHIS: CHIS aims to study various facets of infections and diseases, test medical interventions, and accelerate vaccine development.

What are the benefits of CHIS?

Faster Vaccine Development: CHIS can accelerate vaccine development by providing critical data on immune responses and safety, reducing the need for large phase-3 trials.

Understanding Infections: CHIS helps researchers gain valuable insights into the various facets of infections and diseases, aiding in the development of effective treatments.

Controlled Environment: CHIS allows for the study of diseases in a controlled and monitored setting, minimizing risks to the wider population.

Cost-Effectiveness: CHIS can potentially reduce the cost and time required for vaccine development.

What are the challenges of CHIS?

Ethical Concerns: CHIS raises ethical issues related to the intentional exposure of healthy volunteers to disease-causing microbes.

Potential for Exploitation: Monetary incentives involved in CHIS may lead to the exploitation of volunteers.

Robust Institutional Mechanisms: Conducting CHIS requires well-trained personnel and strong institutional structures.

Previous Ethical Violations: Instances like the HPV vaccine trial in Andhra Pradesh (2010) highlight the importance of stringent oversight.

Limited Medical Intervention: CHIS may be unsuitable for studying novel diseases with limited medical interventions.