By Vasanthan Kuppuswamy
During the summer of 2013, following my first year as a medical student in the College of Medicine, I traveled to a small rural village in Krishnagiri District, Tamil Nadu, India, to both volunteer with a non-profit organization called the Pallavaram Children’s Medical Center (PCMC) and conduct a research study related to the work of this organization through the Department of Pediatrics. I have worked as a volunteer for PCMC, an organization founded by Dr. Athi Narayan, a neonatologist practicing in Atlanta, GA, for many years now. Although the principal activities of this organization are centered around the Pallavaram Children's Medical Center hospital located in Chennai, over the past two years, we have piloted a small village out-reach project in a village called Maganoorpatti, located in Krishnagiri District, with great success. Prior to beginning medical school, I spent four months in Maganoorpatti developing this pilot program called Healthy Children Brighter Futures.
As part of the outreach project, we have trained four local women who have a background in nursing to travel to the homes of newborn infants and provided monthly wellness checks for them. Our nurses assess height, weight and nutritional status, ensure the child is receiving proper immunizations, advocate exclusive breast feeding, and check the developmental status of the child, among other interventions. Importantly, our nurses assess the infants for "danger signs" which necessitate their immediate referral to healthcare facility. So far, our nurses have been able to identify, triage, and refer several very serious cases for tertiary level care in Chennai. Our organization goes a step further by partnering with other organizations, such as Karuna Trust, in order to arrange for life-saving operations to be done for these infants at minimal cost to the family.
At any one time, we have around 300 infants whom our nurses see in our cohort on a monthly basis. We believe that our intervention is having a great impact on the health of infants in this medically under-served area of Tamil Nadu. This summer, I spent three months in Maganoorpatti conducting a research project on behalf of my University to understand the effects of this program on infant mortality and morbidity. During my stay, I was fortunate enough to be accompanied by both Dr. Athi Narayan, and Dr. Kalpana Manthiram, a pediatric infectious disease fellow at Vanderbilt. They had the opportunity to see first-hand the program that we all have worked so hard to create together. We saw many unique clinical cases that would likely never been seen in the United States.
With regards to the research project to evaluate the efficacy of this program, I worked with my mentor Dr. Andrea Summer in the Department of Pediatrics, as well as a research nurse, Ms. Beth O’Brien, and an epidemiologist, Dr. Sarah Logan, to develop a randomized controlled trial. As part of this pilot study, we have formed two groups, one which receives an intervention by our nurses and one which does not. The outcomes that we will evaluate include uptake of immunizations, growth and developmental status of the infants, incidence of acute hospitalizations, and exclusivity of breast-feeding in the first six months of life.
Perhaps the most difficult part of the entire summer was obtaining ethical “IRB” approval in order to conduct this research. Although the process was relatively straight-forward at MUSC, because this project is trans-national research, IRB approval was also required in India. I worked with an organization called YRG CARE, located in Chennai, in order to obtain this approval. Although our research team began this process in early January, there was an initial lack of responsiveness to our request from YRG CARE. As my first order of business as soon as I arrived in Chennai in May, I visited the YRG CARE office in order to facilitate the process. My initial meeting was troubling – the YRG CARE representative could not verbally guarantee that the ethical review committee would review my project. This was very disconcerting for me, considering that I had already arrived in India and the possibility of not being able to conduct my research was very real. I proceeded to discuss the situation with Dr. Athi Narayan, who directed me to an individual who was a close friend of Dr. Suniti Solomon, the director of YRG CARE. I contacted this individual and asked him to discuss my situation with Dr. Solomon and help persuade YRG CARE to review my project. Eventually, they became amenable to reviewing the project, provided that they could assume an “advisory role” in the project.
However, YRG CARE requested that we make several changes to our research project. For one, they requested that we not use the term “intervention” in our research study. They were also concerned about the duration of my study and the fact that I would be leaving India after 3 months. Furthermore, they requested that I present my research plan to the entire IRB ethical committee, after which the committee would vote on whether to approve my project or not. This was also very worrisome for me. I was worried that the ethical committee would choose not to review my project given their concerns about the duration of my study and how long I was going to be in India. Following my presentation, YRG CARE chose to conditionally approve my project, given a few changes in wording and study procedures in my protocol. After making these changes, YRG CARE fully approved my project at the beginning of July. The problem, at this point, was that all of the changes that I made to my protocol now had to be reviewed by the IRB review board at MUSC. All the while, my time in India was coming to an end, and the possibility that I would not receive full approval by the time I had to leave India seemed to become increasingly possible.
At this point, I had changed my goals for what I wanted to get out of the summer. While my volunteer work continued, in terms of the research project, I wanted to at least have IRB approval and enroll the study participants prior to leaving India. I then submitted my revised protocol, the one that had been approved by YRG CARE, to the IRB review board at MUSC. My fear at this point was that the approval from MUSC would be delayed and I would have to leave India before I received full ethical approval. However, thanks to the work of Dr. Summer and Beth O’Brien, as well as the accommodations that the MUSC IRB board made, I was able to get full ethical approval on July 15th. This gave me three weeks to enroll as many participants as possible. For the next three weeks, the other research personnel and I worked to enroll participants in the research study. Since I knew that the nurses I was working with would be conducting most of the data collection after my departure, I involved them heavily in enrolling participants and gaining informed consent. By the time I had left India, I had enrolled most participants, and the felt that the nurses were fully capable of completing data collection. To ensure successful completion of this project, I am returning to India in December to fully wrap it up.
Looking back on my summer in India, I realized that much of my time went into gaining ethical approval for my project, which was NOT my intention. Yet I gained a great deal of experience in dealing with adversities and this developed a sense of perseverance within me. When I left India, I felt that I had truly accomplished something. I had successfully set up my research project and initiated it, I had gained a great deal of clinical experience by seeing several neonatal cases along with Dr. Narayan and Dr. Manthiram, and I also had the opportunity to spend a great deal of time with my extended family, with whom I may not be able to spend as much time with in the coming years. I appreciate the opportunity provided by the Center for Global Health that allowed me to embark on this unique opportunity. I look forward to returning to India briefly in December in order to wrap up this project and also presenting about my summer in the spring.
Vasanthan is a second year medical student and recipient of the MUSC Center for Global Health trainee travel grant.