India has taken its first step to introduce Controlled Human Infection Studies (CHIS), used in many countries for vaccine and treatment development. Riddled with ethical issues, CHIS has still now been a no-go area for India, but Indian Council of Medical Research’s (ICMR) Bioethics Unit is set to change this.
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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.
ICMR’s Bioethics Unit has introduced a consensus policy statement which is now open for comment and argues the case for bringing in CHIS. The document talks of the need, benefits, and challenges associated with CHIS.
“This paper is aimed at addressing a variety of ethical issues so that research can be conducted in India without compromising on ethical principles while ensuring the protection of human participants,” notes ICMR.
ICMR notes that 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.
“Hence these studies need a streamlined ethics review process with additional ethical oversight and safeguards to protect the study participants,’‘ notes the paper.
It adds that the deterrents include technical, clinical, ethical and legal contentions, amid unique socio-cultural context.
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, said ICMR.
It further states that 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. Collaborations should be encouraged to get the right expertise which may not be available with one centre/research team.
“ICMR Bioethics Unit has formulated a consensus policy statement to address the ethical concerns related to the conduct of CHIS and this has been developed through a process of rigorous engagement with experts in the last few months. These studies may play a crucial role in advancing the scientific understanding of infectious diseases and thereby accelerating the development of treatment strategies. However, being a very specialised type of research involving deliberately infecting healthy volunteers with a specific pathogen under controlled conditions, these may have a lot of ethical challenges and an attempt has been made to address these issues in this document. The document is being posted on ICMR website for public consultation till August 16,” noted ICMR.