Consultation on the feasibility and ethics of specific, probable Controlled Human Infection Model study scenarios in India: A report

AUTHORS

Manjulika Vaz, Olinda Timms, Anuradha Rose, Abi Manesh, Anant Bhan

ABSTRACT

On March 6, 2019, a workshop was held as part of a larger public consultation exercise to evaluate the perceptions of participants from diverse backgrounds of studies involving Controlled Human Infection Models (CHIMs) (1),(2) in India, through three specific case scenarios. This workshop was organised by the Health and Humanities Division of the St. John’s Research Institute, Bangalore with funding from the Translational Health Science and Technology Institute (TSHTI), Faridabad (www.thsti.res.in), an autonomous institute of the Department of Biotechnology, Government of India This was an on-going effort of the Division to bring public discourse centre stage in the discussion on the use, ethics and regulations related to CHIM studies, and the introduction of such studies in India. Participants included epidemiologists, community/public health experts, microbiologists, infectious disease specialists, basic and translational scientists, ethicists, journalists and lawyers (See names and profiles below*). The purpose of the workshop was to discuss three CHIM scenarios for diseases of public health importance in India (malaria, typhoid and chikungunya) and understand and deliberate on the relevant scientific, safety, ethical and regulatory considerations Malaria and typhoid infection were chosen as they are important public health problems in India where new vaccines/ treatments may be amenable to testing /using a CHIM model, and for which treatment guidelines are available. While chikungunya infection, also an emerging public health problem in the country, was chosen as a contrasting scenario – viral infection, absence of specific treatment, longer duration, persistent sequelae. The need to explore specific case scenarios evolved from an earlier deliberation during a 14th World Congress of Bioethics Pre-congress Workshop (3) (also organised by the Division of Health and Humanities), where preliminary results of a study on public perceptions to a generic CHIM scenario (3) were presented.

Click here to read the article, published in the Indian Journal of Medical Ethics.