A research group based at the Kenya Medical Research Institute (KEMRI) in Nairobi is exploring the risk for HIV infection in children breast fed by HIV infected mothers. A previous study has suggested that breast feeding may lead to a two-fold increase in the risk of HIV transmission. This study has some design flaws and given the possible implications of the study the investigators at KEMRI wish to repeat the study. If by breast feeding, an HIV+ mother significantly increases the risk of infection in her infant, the present recommendations to mothers of always breast feeding her child regardless of her HIV status may have to be altered.
The study is designed such that during a woman's third trimester prenatal visit for an in hospital delivery at Nairobi General Hospital (and with her consent), blood is drawn to determine her HIV status. The woman is informed of her status prior to delivery and counseled. As part of the counseling process it is recommended that she not breast feed her infant and assured that she will be provided with all the necessary infant formula free of charge. Some still choose to breast feed, and some choose to only feed with infant formula. The HIV status of the children is assessed at birth and every six months up to 18 months, and the mother's status is reassessed at 18 months. All children in the study are seen in a special clinic at least every two weeks where medication is free and available. All mothers who participate in the study must sign an informed consent form that clearly describes the study design, the potential risks, the potential benefits, and states that the patient can withdraw at any time without feat of prejudicial treatment.
One of the women seen in the prenatal clinic at the 24th week of pregnancy and testing positive for HIV is a healthy 32 year old married woman with two healthy children (2 and 5). She has a previous history of a blood transfusion during her last delivery because of a ruptured placenta previa. According to protocol she is advised of the general benefits of breast feeding her child and the countervailing risks of HIV transmission and advised by her physician to consider alternative infant feeding options. A week before her expected date of delivery and after several difficult discussions with a health care worker and her husband, she decides that she will breast feed her child. She believes that by participating in the study she may reduce the risk of her child being infected. Her husband strongly objects and decides to approach the investigator to try to change his wife's decision. He states that he will not sign the informed consent form and that he will seek an order from the court to prevent his wife from breast feeding the child and participating in the study.
Comment on the ethics of the study. Some of the following questions should be considered in the discussion:
- What are the right of the husband in terms of breast feeding the child and participation in the study?
- Does the provision on free biweekly clinic visits and free medication constitute a form of coercion?
- Did the attached policy statements provide sufficient guidance to the Health Ministry so that it could have taken steps to prevent this conflict? Did they provide sufficient guidance to the Justice Ministry to aid them in their efforts to resolve this conflict?
- What additional information would you want in order to advise on further policy development?
Note: Cases are fictional, but based on real events. All organization and individual names have been changed.
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