Ethical Aspects of Controlled Human Infection Studies

Context:

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.

Relevance:

GS II: Health

Dimensions of the Article:

1. Controlled Human Infection Studies (CHIS) and Ethical Concerns
2. Ethical Challenges in Controlled Human Infection Studies (CHIS)
3. The Way Forward in Addressing Ethical Concerns

Controlled Human Infection Studies (CHIS) and Ethical Concerns

• CHIS is a research model that deliberately exposes healthy volunteers to pathogens in controlled settings.
• This research approach has been employed in various countries to study diseases like malaria, typhoid, and dengue.

Benefits of Implementing CHIS Recognized by ICMR

• Deeper Disease Understanding: CHIS offers unique insights into the development and progression of infectious diseases, contributing to a more profound understanding of these conditions.
• Accelerated Treatment and Vaccine Development: Researchers can study disease progression more rapidly using CHIS, which can expedite the development of new treatments and vaccines.
• Cost-Effectiveness: CHIS requires smaller sample sizes compared to large clinical trials, making it a more cost-effective research model.
• Informing Public Health Responses: Findings from CHIS can be instrumental in shaping public health responses, healthcare decision-making, and policy development.
• Preparedness for Future Pandemics: Understanding disease dynamics through CHIS can enhance preparedness for handling potential future pandemics effectively.
• Community Empowerment: Involving communities in CHIS research can empower them to take ownership of their health and actively participate in healthcare initiatives.

Ethical Challenges in Controlled Human Infection Studies (CHIS)

• Potential Harm to Participants: Exposing healthy volunteers to pathogens raises concerns about possible harm to their health and well-being.
• Compensation Complexity: Determining appropriate compensation for CHIS participants is challenging, as offering too much or too little compensation can pose ethical dilemmas.
• Informed Consent Concerns: Ensuring informed consent becomes a challenge when compensation incentives might unduly influence a participant’s decision or when vulnerable individuals may be exploited.
• Risk of Disease Transmission: There is a concern about the potential transmission of the pathogen to third parties beyond the research participants.
• Representation of Marginalized Communities: CHIS may disproportionately involve participants from low-income or marginalized communities, raising issues of fairness and equity.

The Way Forward in Addressing Ethical Concerns

• Establish Independent Ethics Committee: The first step is to create an independent ethics committee comprising experts in medical ethics, infectious diseases, and legal representatives. Their role is to thoroughly evaluate CHIS protocols and safeguard participant safety and rights.
• Informed and Voluntary Participation: Full disclosure of risks and benefits is essential, ensuring that volunteers are fully informed about the potential consequences of participating in CHIS. Participants must provide voluntary informed consent and retain the right to withdraw from the study at any time without facing any penalties.
• Minimizing Participant Risk: Robust measures should be in place to minimize the risk to participants. This includes close medical monitoring during the trial and providing access to appropriate medical care and treatment if any participant falls ill during the study.

-Source: The Hindu