Public health research ethics – Indian case studies

Public Health research and practice exposes individual researchers and practitioners to dilemmas that are slightly different from those of clinical research. This is because in public health, the focus of research is not an individual patient, but the population. The nature of dilemmas confronted in public health research impinges upon community identities, individual vs collective risks and benefits, and power relations between gate keepers and actual participants.

The Prevention of Parent-to-child Transmission Programme: Is it fair to women.

In February 2014, the Government of India launched a multi-antiretroviral drug regimen to treat infected women and infants in efforts to reduce parent-to-child transmission (PTCT) of the human immunodeficiency virus (HIV). The announcement has been long awaited because the multidrug regimen can reduce the risk of transmission during childbirth from 30% – 35% to less than 2% with replacement feeding.

A standardised patient study of primary healthcare services.

There is little evidence on the quality of care patients receive in clinics in resource-poor settings. This study reports on the quality of primary care services in the public and private sectors in India, using about 926 clinical interventions between 305 medical care providers and 22 unannounced standardised patients in rural and urban settings.

Compensation for trial-related injury: does simplicity compromise fairness.

India’s regulatory framework for research ethics is two pronged. Schedule Y of the Drugs and Cosmetics Act, 1940, of the Government of India, lays down the requirements for undertaking clinical trials for drugs and medical devices in India; it also requires compliance with the ICMR’s Ethical guidelines for biomedical research on human participants for such trials. Other health research may use the ICMR’s guidelines but this is not mandatory. The regulatory framework is operationalised through the offices of the Central Drugs Standard Control Organisation. However, the mechanisms of monitoring drug trials using this framework have proved to be rather weak.

The legacy of scandals and non-scandals in research and its lessons for bioethics in India.

A case study entitled “Observational study of cervical cancer”, on research undertaken in a south Asian country, published in a compilation of case studies by Cash and others , is the subject of a collection of commentaries in this issue of IJME. The range of responses reflects the commentators’ individual disciplinary orientations and views on the state of medical practice in those times, and the ethical standards that applied.

Dr Vasantha Muthuswamy.

Dr Vasantha Muthuswamy looks like the quintessential senior government officer from south India. Her quiet demeanour belies her towering personality and achievements during her academic and professional career.

Conference report.

The theme of the Third National Bioethics Conference was governance of healthcare, addressing issues of ethics, equity and justice. The conference that took place in New Delhi, the fulcrum of policy making in India, attracted over 350 participants from 7 countries. In all there were 58 papers in 25 parallel sessions, and 12 workshop sessions spread over four days from November 17 to 20, 2010.

Ethics in human resource management: potential for burnout among healthcare workers in ART and community care centres.

This paper examines ethical dilemmas in providing care for people with HIV/AIDS. Healthcare providers in this sector are overworked, particularly in the high prevalence states. They are faced with the dual burden of the physical and the emotional risks of providing this care. The emotional risks result from their inability to control their work environment, while having to deal with the social and cultural dimensions of patients’ experiences. The physical risk is addressed to some extent by post exposure prophylaxis. But the emotional risk is largely left to the individual and there is little by way of institutional responsibility for minimising this. The guidelines for training workers in care and support programmes do not include any detailed institutional mechanisms for reducing workplace stress. This aspect of the programme needs to be examined for its ethical justification. The omission of institutional mechanisms to reduce the emotional risks experienced by healthcare providers in the HIV/AIDS sector could be a function of lack of coordination across different stakeholders in programme development. This can be addressed in further formulations of the programme. Whatever the reasons may be for overlooking these needs, the ethics of this choice need to be carefully reviewed.