_page-0001.jpg)
What's the article about?
- It talks about the ICMR Consensus Policy Statement for the Ethical Conduct of Controlled Human Infection Studies (CHIS) in India, 2023.
Relevance:
- GS3: Awareness in the fields of Bio-technology and issues relating to Intellectual Property Rights; Essay;
- Prelims
Context:
- Recently, ICMR Bioethics Unit has formulated a consensus policy statement to address the ethical concerns related to the conduct of Controlled Human Infection Studies in India.
Analysis:
- What is Controlled Human Infection Studies (CHIS)?
- CHIS, also called human challenge studies, where healthy volunteers are intentionally exposed to a disease-causing microbe in a highly controlled and monitored environment, has been carried out for hundreds of years, an example being the yellow fever study in the early 1900s to establish that mosquitoes transmit the virus.
- Typically, a less virulent strain of the microbe is used to study less deadly diseases that have proven drugs for treatment.
- They are more often undertaken on a small number of volunteers to understand the various facets of infection and disease, and, occasionally, to accelerate the development process of a medical intervention.
- When used as part of vaccine development, these studies are initiated only when safety and immune responses of the candidate vaccines are known through early phases of clinical testing.
- In the last 50 years, CHIS studies have been carried out with thousands to accelerate vaccine development against typhoid and cholera.
- During the COVID-19 pandemic, the Imperial College London used 36 volunteers to study facets of the SARS-CoV-2 infection. In 2020, WHO approved using CHIS for accelerating COVID-19 vaccine development.
- India and the CHIS:
- Till now, Controlled Human Infection Studies (CHIS) have been avoided in India due to ethical issues surrounding the deliberate harm to participants and fair compensation, among other concerns.
- CHIS is considered ethically sensitive, and there are concerns about the disproportionate harm that could be caused to participants.
- However, with this development, India has taken its first step towards introducing CHIS for vaccine and treatment development.
- Challenges:
- There are several ethical challenges with human challenge studies, which require well-trained and robust systems in place.
- While collaborations with institutions and scientists well versed in conducting such studies are a must, navigating the ethical minefield is a challenge.
- Several clinical trials, including those by or involving the ICMR, have been mired in ethical violations, such as the HPV vaccine trial in Andhra Pradesh, in 2010.
- The ethical challenges while conducting CHIS are of a higher magnitude, the scope for misuse vast, and the repercussions severe. There is potential for exploitation, given the monetary dimension involving volunteers.
Way Forward:
- With the rising burden of existing diseases as well as the emergence of new diseases, India needs to widen its medicinal drug-making ecosystem. Thus, this is a welcome step. However, the aforementioned challenges also need to be addressed to avoid any unwanted consequences.
