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.