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

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

The ethics of volunteer selection and compensation in Controlled Human Infection Models in India

Controlled human infection model studies, or challenge studies, involve the intentional infection of a consenting healthy human volunteer with a virulent organism under controlled conditions Such studies differ from clinical trials in that though both involve healthy volunteers, in challenge studies the potential harm experienced by participants is intended, not merely potentially foreseen, as in clinical trials. Given the special nature of CHIM studies, careful consideration of participant selection and compensation is essential. This paper explores the ethical criteria for recruiting participants in such studies, their own possible motivation such as monetary payment or access to treatment and how that should not be an inducement. It also distinguishes between compensation as inducement and fair compensation for the possible contracting of an illness, isolation and adverse effects, and indicates that more research on the subject needs to be done

Community perspectives on alcohol use among a tribal population in rural southern India.

Background. Alcohol use is common in many cultures. Excessive use of alcohol adversely impacts individuals, families and communities. Medicine, which uses biomedical models and perspectives, views alcohol dependence as a disease. Alcohol use and dependence are complex societal problems, which need to be viewed through multidisciplinary approaches and corrected by adopting intersectoral efforts involving local communities. Methods. We used qualitative methods such as focus group discussions and in-depth interviews to document perspectives on alcohol use among a tribal community in southern India. We recorded traditional norms, changing patterns of use of alcohol and its consequences for individuals, families and the community. Results. Eight focus group discussions and eleven in-depth interviews were conducted. Though consumption of alcohol is part of the local culture, changes in occupation and availability of alcohol has made its consumption a problem. The introduction and easy availability of Indian-made foreign liquor, which is stronger than the locally brewed variety, in government-run outlets has changed the culture of drinking at festivals to drinking more often. This leads to public fights, domestic violence and increasing mortality and morbidity due to road traffic incidents and ill health. The age of initiation into drinking has decreased. Conclusion. The introduction of non-traditional and commercial alcohol use has put a heavy price on tribal and rural people. Community-based interventions targeting young children and adolescents may pay more dividends than pursuing purely medical treatments for problem drinkers.

Survey of ethical issues reported by Indian medical students: basis for design of a new curriculum.

Education in ethics is now a formal part of the undergraduate medical curriculum. However, most courses are structured around principles and case studies more appropriate to western countries. The cultures and practices of countries like India differ from those of western countries. It is, therefore, essential that our teaching should address the issues which are the most relevant to our setting. An anonymised, questionnaire-based, cross-sectional survey of medical students was carried out to get a picture of the ethical problems faced by students in India. The data were categorised into issues related to professional behaviour and ethical dilemmas. Unprofessional behaviour was among the issues reported as a matter of concern by a majority of the medical students. The survey highlights the need to design the curriculum in a way that reflects the structure of medical education in India, where patients are not always considered socio-culturally equal by students or the medical staff. This perspective must underpin any further efforts to address education in ethics in India.

How ‘informed’ is informed consent? Findings from a study in South India.

A qualitative study using in-depth interviews was carried out among patients and doctors working in a private hospital in Tamil Nadu, to understand perceptions of informed consent. Audio-recorded interviews were transcribed verbatim and a framework analytical approach was used in analysis. Emergent themes ranged from perceptions on informed consent, and discussing health concerns and decision making, to information provided by and expectations from doctors, and suggestions for improvement. Most patients were unfamiliar with the kind of information provided in the informed consent process; a few felt that the information was inadequate. Decision making about surgery was left mostly to the doctor. Poor literacy in patients was seen as a barrier to effective communication by doctors.