ICMR argues for controlled human infection studies

  • July 25, 2023
  • Posted by: OptimizeIAS Team
  • Category: DPN Topics
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ICMR argues for controlled human infection studies

Subject: Economy

Section: External Sector

Context:

  • India has taken its first step to introduce Controlled Human Infection Studies (CHIS), used in many countries for vaccine and treatment development.

About CHIS:

  • 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 ethicsissues like:
      • deliberate harm,
      • possible disproportionate payment and hence inducements,
      • third-party risk,
      • withdrawal from the study and research with vulnerable participants.

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 is a relatively new research model that 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.
  • These studies may play a crucial role in advancing the scientific understanding of infectious diseases and thereby accelerating the development of treatment strategies.

About ICMR:

  • The Government of India funds ICMR.
  • It comes under the Department of Health Services (DHS), Ministry of Health and Family Welfare (MoH&FW).
  • The headquarters of ICMR is in New Delhi.
  • It is neither a statutory body nor a regulatory body.
  • ICMR hosts Clinical Trials Registry – India (CTRI). It was established on 20th July 2007.
    • It is a free and online public record system for the registration of clinical trials being conducted in India.
    • Till 15th June 2009, the clinical trial registry was a voluntary measure; after which the Drugs Controller General of India (DCGI) has made trial registration at CTRI mandatory.
  • Importance – It encourages registration of clinical trials before the enrolment of the first participant.
  • It has been publishing the Indian Journal of Medical Research (IJMR) since 1913.
  • ICMR’s National Institute of Nutrition (NIN) was established in 1918 as ‘Beri Beri Enquiry’ at the Pasteur Institute, Coonoor, Tamil Nadu.
    • Sir Robert McCarrison was the founder of the ‘Beri Beri’ enquiry unit now known as NIN.
  • Union Health Minister of India presides over the governing body of ICMR.
  • Prof. Balram Bhargava, secretary of DHS, is the Director-General of ICMR.
  • There are 27 institutes/regional medical research centres under ICMR.
economy ICMR argues for controlled human infection studies