Controlled Human Infection Studies

    India introduces CHIS
    Role of Bioethics Unit
      Under Indian Council of Medical Research (ICMR)
      Enabling CHIS in India
    Introduction of consensus policy statement
      Provides arguments for CHIS introduction
      Discusses need, benefits, and challenges of CHIS
    Also known as human challenge trials
    Involves intentional exposure
      Of volunteers to pathogens
    Used for developing
    Addressing infectious diseases
      30% of total disease burden in India
    Provides unique insights
      Into disease pathogenesis
    Speeds up development
      Of novel medical interventions
    Accelerated, cost-effective, and efficient outcomes
      Even with smaller sample sizes
    Social value
      Contribution to public health response
      Aid in healthcare decision making
      Influence on policies and economic benefits
      Improvement of pandemic preparedness
      Community empowerment
    Ethical issues
      Deliberate harm
      Disproportionate payments and inducements
      3rd party risks
      Research using vulnerable participants
    Complexity of studies
    Exposure of healthy volunteers to pathogens
      In controlled environments
    Results used for
      Better understanding of diseases
        Like malaria
        Like typhoid
        Like dengue
      Development of appropriate

Controlled Human Infection Studies (CHIS), also known as human challenge trials, have been introduced in India. The Bioethics Unit under the Indian Council of Medical Research (ICMR) plays a crucial role in enabling CHIS in the country. A consensus policy statement has been introduced to provide arguments for CHIS’s introduction, discussing the need, benefits, and challenges associated with such studies.


  • Controlled Human Infection Studies involve intentional exposure of volunteers to pathogens. These studies are primarily used for the development of vaccines and treatments.


  • Addressing Infectious Diseases: CHIS can help in tackling infectious diseases that contribute to 30% of the total disease burden in India.
  • Unique Insights: These studies provide researchers with unique insights into disease pathogenesis.
  • Speeding up Development: CHIS accelerates the development of novel medical interventions.
  • Cost-Effective and Efficient Outcomes: CHIS can lead to accelerated, cost-effective, and efficient outcomes, even with smaller sample sizes.
  • Social Value: The studies offer various social benefits, including contributing to public health responses, aiding healthcare decision-making, influencing policies and economic benefits, improving pandemic preparedness, and empowering communities.

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  • Ethical Issues: CHIS raises ethical concerns due to deliberate harm caused to volunteers, the possibility of disproportionate payments and inducements, risks to third parties, and the involvement of vulnerable participants in research. copyright©
  • Complexity of Studies: Conducting CHIS can be complex and requires careful planning and ethical considerations.


  • CHIS involves exposing healthy volunteers to pathogens in controlled environments.
  • The results obtained from these studies are used to better understand diseases like malaria, typhoid, and dengue, and to develop appropriate vaccines and treatments.


Controlled Human Infection Studies (CHIS) present a potential pathway for addressing infectious diseases and accelerating the development of medical interventions in India. While these studies offer valuable insights and social benefits, they also come with ethical challenges that must be carefully addressed. With the involvement of the Bioethics Unit under the Indian Council of Medical Research, the introduction of CHIS in India is expected to be guided by a thoughtful and responsible approach.


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