Controlled Human Infection Studies and Ethical Concerns | 27 Jul 2023

For Prelims: Controlled Human Infection Studies , Malaria, Dengue, Vaccines

For Mains: Indian Council of Medical Research Guidelines, Ethical Concerns Related to Controlled Human Infection Studies

Source: TH

Why in News?

The Indian Council of Medical Research’s (ICMR) Bioethics Unit has drafted a consensus policy statement addressing the ethical aspects of Controlled Human Infection Studies (CHIS), opening the door for its potential implementation in India.

What is Controlled Human Infection Studies and Related Ethical Concerns?

  • About:
    • CHIS is a research model that intentionally exposes healthy volunteers to pathogens under controlled conditions.
    • It has been utilized in various countries to study diseases such as malaria, typhoid, and dengue.
  • Benefits of CHIS Implementation: ICMR recognizes that CHIS has the potential to provide numerous benefits for medical research and public health:
    • Insights into Disease Pathogenesis: CHIS can offer unique insights into how diseases develop and progress, leading to a deeper understanding of infectious diseases.
    • Accelerated Medical Interventions: By allowing researchers to study disease progression more rapidly, CHIS can expedite the development of new treatments and vaccines.
    • Cost-effective and Efficient Outcomes: CHIS requires smaller sample sizes compared to large clinical trials, making it a more cost-effective research model.
    • Contributions to Public Health Response: Findings from CHIS can inform public health responses, healthcare decision-making, and policy development.
      • Understanding disease dynamics through CHIS can enhance preparedness for future pandemics.
    • Community Empowerment: Involving communities in CHIS research can empower them to take ownership of their health and participate actively in healthcare initiatives.
  • Ethical Challenges:
    • Deliberate Harm and Participant Protection: Exposing healthy volunteers to pathogens raises concerns about potential harm to participants.
    • Inducement and Compensation: Determining appropriate compensation for participants in CHIS can be challenging.
      • Offering too much compensation might unduly induce people to participate, potentially compromising informed consent.
      • Conversely, offering inadequate compensation might exploit vulnerable individuals.
    • Third-party Risk: The risk of disease transmission to third parties beyond the research participants is a concern.
    • Justice and Fairness: There is a concern that CHIS may disproportionately involve participants from low-income or marginalized communities.

Way Forward

  • Ethical Considerations: The first step is to establish an independent ethics committee to evaluate the CHIS protocols thoroughly.
    • The committee should consist of experts in relevant fields, including medical ethics, infectious diseases, and legal representatives, to ensure that participant safety and rights are protected throughout the process.
  • Informed Consent and Withdrawal: Volunteers should be fully informed about the risks involved in participating in CHIS.
    • Informed consent should be obtained, and participants should have the right to withdraw at any time without penalty.
  • Risk Minimization and Medical support: Measures should be in place to minimize the risk to participants.
    • This includes close medical monitoring during the trial and access to appropriate medical care and treatment if any participant becomes ill.