Ethical issues encountered when researching mother-to-child transmission of HIV through breastfeeding: The touro Ethiopia breastmilk study

Background: Ethical dilemmas faced in international research are rarely predictable and often arise after receiving IRB approval. Quick response is essential to protect human subjects but making immediate changes to study protocols is rarely a quick process. Barriers to quick response can include communication delays between study staff and investigators, delays in the identifying problems, and difficulties communicating the realities of the work to US-based IRBs. Methods: This work examines an ethical dilemma faced by researchers working on the Touro Ethiopia Breasmilk study which aimed to to validate the use of the FACScount CD4 analyzer to assess CD4+ T-cells in breastmilk and assess the impact of breastfeeding practices on breastmilk CD4+ T-cell counts. Major Results: While the initial protocol was approved by the Touro University and the Jimma University Institutional Review Boards, important ethical issues arose early in the study implementation. Specifically, participants were unable to produce enough breastmilk during the first days postpartum. This may have been stressful for them during a vulnerable time and may have harmed the breastfeeding baby. Some mothers dropped out of the study, despite a fairly good incentive of 300 birr, the equivalent of a monthly wage for a security guard in much of rural Ethiopia. The second aim of the study was dropped based on these early experiences with study participants. Recommendations: Researchers should be willing to revise research protocols based on experience on the ground, as protocols may meet IRB requirements but experience may indicate that protocols are not beneficial for participants.