Where is the Ethics?

-Mahesh Devnani

The October issue of Health Affairs contain seven articles on ‘Quality of health care in India’^1-7. One of them is a commentary¹, two are based on secondary data^2-3 and 4 studies involve human subjects^4-7. This is a welcome step which would hopefully strengthen the discussion on quality in Indian healthcare sector.

 

However, out of the 4 studies involving human subjects, Mohanan et al⁷ is silent on any review board or ethical approvals taken for the study, and only 2 studies^5-6 partially mention about participant’s consent whereas the other two studies^4,7 are completely silent on this important aspect of research involving human subjects. Two studies^2-3 based on secondary data do not mention if the studies were exempted from review/ethical board approval (Table 1).

Table 1: Review board/ethical approval and consent

Article	Involvement of human subjects	Mentions about Review Board /Ethical approval or exemption	Whether the consent was taken from participants in local language
Mohanan et al7	Yes	No	No mention
Das et al4	Yes	Yes	No mention
Babiarz et al5	Yes	Yes	Mentions that consent was not needed for DLHS-3 data, but nothing mentioned about consent in household survey conducted in Gujarat
Le et al6	Yes	Yes	Mentions that patients were excluded from study if they were unable to provide consent
Munshi et al2	No	No	N.A.
Morton et al3	No	No	N.A.

Explicit communication of review board approvals and informed consent is an important aspect of research publication involving human subjects^8-9 and it is surprising that editorial and peer review process of Health Affairs overlooked this aspect. International agencies and researchers have long been allegedly accused of unethical research practices involving poor people of developing countries¹⁰, hence suo moto communication of review board approvals and methodology of obtaining informed consent becomes more important while publishing such studies.

While it is heartening to see a cluster of articles on quality of care in India, it is expected that the commonly accepted norms of ethical research publication are also followed.

Notes

1. Mohanan M, Hay K, Mor N. Quality of health care in india: challenges, priorities, and the road ahead. Health Aff (Millwood) 2016;35:1753-8.
2. Munshi V, Yamey G, Verguet S. Trends in state-level child mortality, maternal mortality, and fertility rates in India. Health Aff (Millwood) 2016;35:1759-63.
3. Morton M, Nagpal S, Sadanandan R, Bauhoff S. India's largest hospital insurance program faces challenges in using claims data to measure quality. Health Aff (Millwood) 2016;35:1792-9.
4. Das J, Mohpal A. Socioeconomic status and quality of care in rural India: New evidence from provider and household surveys. Health Aff (Millwood) 2016;35:1764-73.
5. Babiarz KS, Mahadevan SV, Divi N, Miller G. Ambulance service associated with reduced probabilities of neonatal and infant mortality in two Indian states. Health Aff (Millwood) 2016;35:1774-82.
6. Le HG, Ehrlich JR, Venkatesh R, Srinivasan A, Kolli A, Haripriya A, et al. A sustainable model for delivering high-quality, efficient cataract surgery in southern India. Health Aff (Millwood) 2016;35:1783-90.
7. Mohanan M, Babiarz KS, Goldhaber-Fiebert JD, Miller G, Vera-Hernández M. Effect of a large-scale social franchising and telemedicine program on childhood diarrhea and pneumonia outcomes in India. Health Aff (Millwood) 2016;35:1800-9.
8. Taljaard M, McRae AD, Weijer C, Bennett C, Dixon S, Taleban J, et al. Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials. BMJ 2011;342:d2496.
9. Schroter S, Plowman R, Hutchings A, Gonzalez A. Reporting ethics committee approval and patient consent by study design in five general medical journals. J Med Ethics 2006;32:718-23.
10. Angell M. The ethics of clinical research in the Third World. N Engl J Med 1997;337:847-9.