Human Challenge Studies
Source: The Hindu
GS II: Health
Overview
- News in Brief
- About Human Challenge Studies
Why in News?
On July 17, the ICMR Bioethics Unit posted the consensus policy statement for the ethical conduct of controlled human infection studies (CHIS), also known as human challenge studies, in India.
About the Studies
- It is also known as controlled human infection studies or CHIS.
Photo by Nguyễn Hiệp on Unsplash - Its application in understanding infectious diseases.
- It studies involve deliberately exposing human volunteers to disease-causing pathogens to gain insights into various facets of infection and disease pathogenesis.
- These studies are conducted to supplement traditional human clinical trials and to speed up the process of finding safe and effective interventions like drugs or vaccines.
- The need for undertaking the studies is driven by the high disease burden and mortality from infectious diseases in countries like India.
- These studies can provide valuable insights into infectious agents, their transmission, and potential prevention strategies.
Safe Guarding Participants
- Special safeguards are put in place to reduce harm to participants in studies.
- The infectious agents used are typically well-known and studied, and less virulent forms of the pathogens are often used to minimize risks.
- Additionally, a rescue remedy is made available to prevent the disease from progressing to a severe form, ensuring the safety of participants.
Ethical Challenges
- Undertaking human challenge studies poses ethical dilemmas since individuals are deliberately subjected to pathogens, leading to a multifaceted ethical issue.
- It is of utmost importance to guarantee that informed consent is provided and that criteria for the exclusion of participants with pre-existing medical conditions are cautiously examined as integral components of ethical considerations.
Consensus Policy of ICMR
- The Indian Council of Medical Research (ICMR) has posted a consensus policy statement for the ethical conduct of studies in India.
- According to the statement, only healthy individuals in the 18-45 years age group will be enrolled.
- Children, pregnant or lactating women, and those planning to conceive during the study period will not be enrolled, unless deemed appropriate.
- The amount of payment for participation will be mentioned in the consent form but will be revealed to the volunteer only after they have consented to participate.
- Studies represent a unique approach to studying infectious diseases, and their ethical conduct is of utmost importance to safeguard the well-being of the participants and to ensure the validity and reliability of the research findings.Options
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