Battling a deliberately-acquired infection to help find a cure
- August 25, 2023
- Posted by: OptimizeIAS Team
- Category: DPN Topics
No Comments
Battling a deliberately-acquired infection to help find a cure
Subject :Science and technology
Section: Health
Context:
Researchers at the University of Maryland had conducted a “controlled human infection study” (CHIS), also called a human challenge study to test a new vaccine that one day may hopefully prevent Shigellosis.
Details:
- A CHIS is a relatively quick and efficient way to assess if a vaccine might work.
- India is likewise considering introducing CHIS.
ICMR’s proposal for CHIS:
- CHIS is a research model that intentionally exposes healthy volunteers to pathogens under controlled conditions.
- The CHIS is proposed by the Indian Council of Medical Research’s (ICMR) Bioethics Unit.
- Outside of India, this relatively new research model which involves intentionally exposing healthy volunteers to pathogens in a controlled environment, has been used to study malaria, typhoid, dengue, etc.
- The deterrents include technical, clinical, ethical and legal contentions, amid unique socio-cultural context.
- Concerns include:
- India has so far stayed away from CHIS, because regardless of the potential scientific benefits, these studies are ethically sensitive and raise concerns about contentious research ethics issues like:
- deliberate harm,
- possible disproportionate payment and hence inducements,
- third-party risk,
- withdrawal from the study and research with vulnerable participants.
- India has so far stayed away from CHIS, because regardless of the potential scientific benefits, these studies are ethically sensitive and raise concerns about contentious research ethics issues like:
Need for the CHIS:
- India carries a high burden of morbidity and mortality from infectious diseases.
- They contribute about 30% of the disease burden in the country.
- Finding novel, efficient, and cost-effective alternatives to existing methods of research in these diseases and their prevention is imperative to reduce this burden.
- CHIS helps provide unique insights into disease pathogenesis and can accelerate the development of novel medical interventions.
- CHIS offers accelerated, cost-effective, and efficient outcomes using smaller sample sizes in comparison to large clinical trials.
- Its social value includes:
- potential contributions to public health response to diseases of concern,
- healthcare decision-making,
- policies and economic benefits,
- improved pandemic preparedness, and
- community empowerment.
- ICMR has also cautioned that CHIS is a highly complex area and may require collaborations at different levels between researchers, institutions, organisations and/or between different countries.
What is the fundamental difference between human clinical trials and human challenge studies?
Sr.No. | Human Clinical trials | Human Challenge Trials or CHIS |
1. | Participants are strongly advised to adopt and adhere to safety measures to avoid getting infected and any exposure to the microbes and infection arising in the participants from such an exposure is left to chance. | Volunteers are deliberately exposed to disease-causing pathogens. |
2. | Undertaken to study the safety and efficacy of drugs and vaccines | Carried out to understand the various facets of infection and disease pathogenesis besides selecting the best candidate drug or vaccine. |
3. | Adverse effects of the candidate drugs or vaccines are not known | Though adverse effects of the candidate drugs or vaccines are not known, volunteers face an additional risk when deliberately exposed to the pathogen |
4. | Undertaken to study all kinds of diseases. | Often undertaken to study “less deadly diseases” such as influenza, dengue, typhoid, cholera and malaria. |