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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