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Controlled Human Infection Studies (CHIS)

Facts for Prelims (FFP)

Source: TH

 Context: India is taking its first step towards introducing Controlled Human Infection Studies (CHIS), a research model used in other countries for vaccine and treatment development.

 

What is CHIS?

It is a research model used to intentionally expose healthy volunteers to pathogens in a controlled environment to study diseases and develop vaccines and treatments for diseases like malaria, typhoid, and dengue. The goal is to gain insights into disease pathogenesis and find efficient and cost-effective ways to prevent and treat infectious diseases.

 

The issues with CHIS (Controlled Human Infection Studies) include:

  • Ethical Sensitivity: CHIS involves intentionally exposing healthy volunteers to pathogens, raising concerns about deliberate harm and protecting participants’ rights.
  • Disproportionate Payment: Concerns about inducements and potential financial incentives for volunteers to participate in risky studies.
  • Third-Party Risk: The risk of transmission of the pathogen to individuals outside the study, leading to potential community spread.
  • Research with Vulnerable Participants: Ensuring that vulnerable individuals, such as pregnant women or children, are not exposed to undue risks during CHIS.
  • Technical and Clinical Challenges: Ensuring proper scientific procedures and safety protocols are followed in the controlled environment.
  • Legal Contentions: Addressing potential legal issues related to participant consent and liability.
  • Socio-Cultural Context: Considering unique socio-cultural factors that may impact the acceptability and feasibility of CHIS in different communities.

 

The Indian Council of Medical Research’s (ICMR) Bioethics Unit has introduced a consensus policy statement, open for public comment, to address the ethical concerns associated with CHIS. The aim is to conduct research in India while protecting human participants and ensuring ethical principles are upheld.