This case study uses the same case study as in the other modules. In this case study, some specific issues related to ethical considerations in the conduct of IR are explained.

Part 1.

The mhealth application was developed by a German technological organization for use by frontline community health workers in Bangladesh. An IR was designed to study the use, acceptability of the application by the frontline health workers, ease of use, perceptions of the frontline workers and the community about the application and its effectiveness in improving quality of maternal and child health–care delivery in a district in Bangladesh. It was a cluster randomized controlled study with 10 villages randomized to intervention and 10 villages to routine maternal and child health care by the community health workers.

Who is the focus of intervention in this study? On whom are the outcomes assessed? Who are considered as research participants? Who should give informed consent?

Can any woman in the intervention clusters refuse to have her data collected by the mHealth system? What are the implications of this refusal? Is individual informed consent meaningful in this context?

Part 2.

Issue 1. In the same case study described above it is known that data capture using the routine paper based system has a significant delay in being reported to the information system. Because of this delay there have been several instances of poor data based planning for maternal and child health care delivery services which have resulted in poor outcomes.

Given this knowledge of poor nature of the de facto care, can this be continued in the control clusters? What would be an acceptable standard of care for the control clusters?

Issue 2. During the conduct of the IR, it is found that there is an increase in the number of children with severe acute malnutrition in the age group of 6 months to 1 year.