On going through the study “Improving immunisation coverage in rural
India: clustered randomised controlled evaluation of immunisation
campaigns with and without incentives” in 17th May 2010 issue of BMJ (1),
one is left with a sense of déjà vu as also disquiet; déjà vu with regard
to its claim to be a pioneering study, and disquiet, over its violation of
ethical norms for biomedical research with human participants set down by
the Indian Council of Medical Research (2).
Research studies published earlier have already established the
efficacy of incentives, whether they be in the form of food or conditional
cash transfers, in improving the utilisation of preventive health services
(3,4,5,6,7). Institutional deliveries have increased in India after the
introduction of the Janani Suraksha Yojana (JSY) scheme which provides a
monetary incentive for delivery in a hospital (8).
The ethical dimension lost sight of by the study, was the use of a
control group, in a situation that didn’t warrant a control group. Even
though cluster randomised controlled trial study designs are considered
the best suited to study the effect of public health interventions, there
are ethical issues in such designs that are still being debated (9). The
study population was divided into 3 study groups. Study group A had once
monthly reliable immunisation camp, Study group B had once monthly
reliable immunisation camp with an incentive and no study intervention in
the control group(1). According to the National Family Health Survey
(NFHS-3), in India, 38.6% of children aged between 12-23 months in rural
areas received full immunisation under the Universal Immunisation
Programme (10). In the state of Rajasthan (where the study was conducted),
the percentage of full immunisation in rural areas was 22.1% (11). The 134
villages selected in the study which included 74 control villages had full
immunisation coverage of only 2% in spite of the additional services of
the facilitating Non-Governmental Organization (NGO), Sewa Mandir (1). As
this study involved looking at life-saving basic immunisation services,
the children enrolled in the control group could have been at risk of
dying of a vaccine preventable disease during the period of study since
the vaccine coverage was very poor in the study area. Conducting a study
on utility of incentives to enhance immunization with a control group in
our opinion violates the spirit of General Principle(s) number 3 of the
Indian Council for Medical Research (ICMR) Ethical guidelines for
Biomedical Research on Participants: non-exploitation (2). It is also
violative of the norm that all participants should be beneficiaries in
such a research (2), since most children enrolled in the control group
lost their chance of getting vaccinated on time as compared to the other
groups. Offering of enhanced immunization services in the control area by
the researchers directly or through the partner NGO after study completion
would be too late for these children.
It’s surprising that there are no authors involved in the manuscript
from the partner NGO (Sewa Mandir) or Vidhya Bhawan which is mentioned as
being the university hosting the study in Rajasthan. Involving personnel
from these institutions in the analysis and writing of the manuscript
would have led to local capacity-building of institutions working in the
study area. Also, we feel that the authors at the least should have
thanked their study partners and the study communities without whom the
study would not be possible, but the manuscript does not have such an
acknowledgment section.
References:
1. Banerjee AV, Duflo E, Glennerster R, Kothari D. Improving
immunisation coverage in rural India: clustered randomised controlled
evaluation of immunisation campaigns with and without incentives. BMJ.
2010 May 17;340:c2220. doi: 10.1136/bmj.c2220.
2. Indian Council of Medical Research. Ethical Guidelines for
Biomedical Research on human participants [Internet]. New Delhi: Indian
Council of Medical Research; 2006 Oct [cited 2010 Jun 10]. 120p. Available
from:http://www.icmr.nic.in/ethical_guidelines.pdf
3. Loevinsohn BP, Loevinsohn ME. Well child clinics and mass
vaccination campaigns: an evaluation of strategies for improving the
coverage of primary health care in a developing country. Am J Public
Health. 1987;77:1407-11.
4. Lagarde M, Haines A, Palmer N. Conditional cash transfers for
improving uptake of health interventions in low- and middle-income
countries: a systematic review. JAMA 2007;298:1900-10.
5. Fernald LCH, Gertler PJ, Neufeld LM. Role of cash in conditional
cash transfer programmes for child health, growth, and development: an
analysis of Mexico’s Oportunidades. Lancet 2008; 371:828-37.
6. Gertler PJ, Boyce Simon. An experiment in incentive based welfare:
The impact of PROGRESA on health in Mexico. University of California,
Berkley, April 2001.
7. Morris SS, Flores Rafael, Olinto Pedro, Medina JM. Monetary
incentive on primary health care and effects on use and coverage of
preventive health care in rural Honduras; cluster randomised trial. The
Lancet 2004; 364:2030- 37
9. Osrin David et al. Ethical challenges in cluster randomised
controlled trials: experiences from public health interventions in Africa
and Asia. Bulletin of the WHO 2009;87:772-79
10. International Institute for Population Sciences. Key Indicators
for India from NFHS-3. National Family Health Survey 2005-2006 (NFHS-3). http://www.nfhsindia.org/pdf/India.pdf
11. International Institute for Population Sciences. Key Indicators
for Rajasthan from NFHS-3. National Family Health Survey 2005-2006 (NFHS-
3). http://www.nfhsindia.org/pdf/Rajasthan.pdf
Competing interests:
None declared
Competing interests:
No competing interests
14 June 2010
Deepak MG
Assistant professor in community medicine, Azeezia Institute of Medical Sciences and Research
Anant Bhan, Researcher, Bioethics and Global Health, Pune-411027, India
Rapid Response:
Missed vaccination – Violation of ethics?
On going through the study “Improving immunisation coverage in rural
India: clustered randomised controlled evaluation of immunisation
campaigns with and without incentives” in 17th May 2010 issue of BMJ (1),
one is left with a sense of déjà vu as also disquiet; déjà vu with regard
to its claim to be a pioneering study, and disquiet, over its violation of
ethical norms for biomedical research with human participants set down by
the Indian Council of Medical Research (2).
Research studies published earlier have already established the
efficacy of incentives, whether they be in the form of food or conditional
cash transfers, in improving the utilisation of preventive health services
(3,4,5,6,7). Institutional deliveries have increased in India after the
introduction of the Janani Suraksha Yojana (JSY) scheme which provides a
monetary incentive for delivery in a hospital (8).
The ethical dimension lost sight of by the study, was the use of a
control group, in a situation that didn’t warrant a control group. Even
though cluster randomised controlled trial study designs are considered
the best suited to study the effect of public health interventions, there
are ethical issues in such designs that are still being debated (9). The
study population was divided into 3 study groups. Study group A had once
monthly reliable immunisation camp, Study group B had once monthly
reliable immunisation camp with an incentive and no study intervention in
the control group(1). According to the National Family Health Survey
(NFHS-3), in India, 38.6% of children aged between 12-23 months in rural
areas received full immunisation under the Universal Immunisation
Programme (10). In the state of Rajasthan (where the study was conducted),
the percentage of full immunisation in rural areas was 22.1% (11). The 134
villages selected in the study which included 74 control villages had full
immunisation coverage of only 2% in spite of the additional services of
the facilitating Non-Governmental Organization (NGO), Sewa Mandir (1). As
this study involved looking at life-saving basic immunisation services,
the children enrolled in the control group could have been at risk of
dying of a vaccine preventable disease during the period of study since
the vaccine coverage was very poor in the study area. Conducting a study
on utility of incentives to enhance immunization with a control group in
our opinion violates the spirit of General Principle(s) number 3 of the
Indian Council for Medical Research (ICMR) Ethical guidelines for
Biomedical Research on Participants: non-exploitation (2). It is also
violative of the norm that all participants should be beneficiaries in
such a research (2), since most children enrolled in the control group
lost their chance of getting vaccinated on time as compared to the other
groups. Offering of enhanced immunization services in the control area by
the researchers directly or through the partner NGO after study completion
would be too late for these children.
It’s surprising that there are no authors involved in the manuscript
from the partner NGO (Sewa Mandir) or Vidhya Bhawan which is mentioned as
being the university hosting the study in Rajasthan. Involving personnel
from these institutions in the analysis and writing of the manuscript
would have led to local capacity-building of institutions working in the
study area. Also, we feel that the authors at the least should have
thanked their study partners and the study communities without whom the
study would not be possible, but the manuscript does not have such an
acknowledgment section.
References:
1. Banerjee AV, Duflo E, Glennerster R, Kothari D. Improving
immunisation coverage in rural India: clustered randomised controlled
evaluation of immunisation campaigns with and without incentives. BMJ.
2010 May 17;340:c2220. doi: 10.1136/bmj.c2220.
2. Indian Council of Medical Research. Ethical Guidelines for
Biomedical Research on human participants [Internet]. New Delhi: Indian
Council of Medical Research; 2006 Oct [cited 2010 Jun 10]. 120p. Available
from:http://www.icmr.nic.in/ethical_guidelines.pdf
3. Loevinsohn BP, Loevinsohn ME. Well child clinics and mass
vaccination campaigns: an evaluation of strategies for improving the
coverage of primary health care in a developing country. Am J Public
Health. 1987;77:1407-11.
4. Lagarde M, Haines A, Palmer N. Conditional cash transfers for
improving uptake of health interventions in low- and middle-income
countries: a systematic review. JAMA 2007;298:1900-10.
5. Fernald LCH, Gertler PJ, Neufeld LM. Role of cash in conditional
cash transfer programmes for child health, growth, and development: an
analysis of Mexico’s Oportunidades. Lancet 2008; 371:828-37.
6. Gertler PJ, Boyce Simon. An experiment in incentive based welfare:
The impact of PROGRESA on health in Mexico. University of California,
Berkley, April 2001.
7. Morris SS, Flores Rafael, Olinto Pedro, Medina JM. Monetary
incentive on primary health care and effects on use and coverage of
preventive health care in rural Honduras; cluster randomised trial. The
Lancet 2004; 364:2030- 37
8. Ministry of Health and Family Welfare. Concurrent assessment of
Janani Suraksha Yojana (JSY) in selected states of India, 2009; May.
http://www.mohfw.nic.in/NRHM/Documents/JSY_Study_UNFPA.pdf
9. Osrin David et al. Ethical challenges in cluster randomised
controlled trials: experiences from public health interventions in Africa
and Asia. Bulletin of the WHO 2009;87:772-79
10. International Institute for Population Sciences. Key Indicators
for India from NFHS-3. National Family Health Survey 2005-2006 (NFHS-3).
http://www.nfhsindia.org/pdf/India.pdf
11. International Institute for Population Sciences. Key Indicators
for Rajasthan from NFHS-3. National Family Health Survey 2005-2006 (NFHS-
3). http://www.nfhsindia.org/pdf/Rajasthan.pdf
Competing interests:
None declared
Competing interests: No competing interests