Byline: Aditi. Apte, Girish. Dayma, Himangi. Lubree, Anand. Kawade, Sanjay. Juvekar, Ashish. Bavdekar
This paper describes unique challenges faced during conduct of community research studies in rural population of Maharashtra at Vadu Rural Health Program, Pune, India. Some of the ethical issues faced include difficulty in comprehending the informed consent by rural families with low education levels and ensuring adequate compensation for study participation without undue inducement, ensuring large number of recruitments during early infancy, ensuring adherence to intervention by care-providers, retention of participants especially in studies having long follow-ups and regulatory compliance for serious adverse event reports are major operational challenges. The delays faced in approvals from the Health Ministry Screening Committee and lack of specific regulatory guidance on community-based conduct of studies pose challenges in terms of study timelines and operational aspect of these studies. Provision of study-related information during prestudy visits, designing patient information sheets in simple language, involving the decision-making member of the family, adequate time for families for decision-making are certain measures that have been useful for effective informed consent administration. Collaboration with accredited social health activists and auxillary nurse midwives for line-listing of pregnancies and births and regular conduction of prestudy visits or community sensitization meetings have been useful for the recruitment of large number of study participants during infancy. Strategies such as provision of universal immunization, selection of field research assistants from the local population, regular home visits, and provision of medical care has been helpful in retention of the study participants. Networking with local health facilities and local government bodies has helped in the provision of medical care to the study participants and in the management of serious adverse events. Our experience can provide important learnings to other investigators from developing countries working in the domain of child health.
Community-based research studies are often conducted for testing various public health interventions and for generating epidemiological evidence base for policy decisions. This evidence base is beyond that obtained by individual-based clinical studies which are designed to test an intervention in a specific disease condition in specific population settings. Community-based study aims to further assess generalizability of the health intervention in a population, thus moving from medical approach toward public health approach., Several important public health interventions for child health such as oral rehydration solution and zinc for diarrhea, vaccines for the prevention of childhood infections and micronutrients for prevention of anemia have emerged through community-based research studies.
Field clinical investigations especially amongst children in a rural community of a developing country like India are always in the context of community practices of child rearing, social, and cultural beliefs and concept of health and disease in the community perspective. The complexities in conduct of large research studies in such vulnerable population of developing countries are sparsely reported in Indian literature.
We describe here challenges and lessons learnt during experience of conducting community-based pediatric research studies in rural Maharashtra.
Vadu Rural Health Program
Vadu rural health program (VRHP) is an outreach program of KEM...