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Concern about the Ethical Approval Process for this research by Ginsberg et al

Posted by callcutt on 15 Feb 2022 at 11:27 GMT

I also wish to express concerns about this study protocol.

The research participants appear to be a highly vulnerable population of preterm and Low Birth Weight neonates (and their parents) in both Uganda and Guinea-Bissau.

The recruitment of participants to this study appear to defy basic ethical research principles. For example beneficence, non-maleficence - since it is widely recognised that the early introduction of cow's milk products is associated with an immediate increased incidence of Necrotising Enterocolitis and many other longer-term health risks. The protocol itself mentions the risks "diarrhoea, infectious diseases, and breastfeeding cessation, exposing infants in the formula group to increased risk of adverse events, hospitalization or death compared to infants in the EBF group".

Another research principle should be to avoid Conflicts of Interest but there named formula manufacturer funding this research, a company, already with a significant market share in the US, Uganda and Guinea-Bissau where the researchers are located. There does not appear to be any indication that the logo and brand name of their products will not be on display during the research, which could be further product promotion to parents involved and to the staff in the research sites.

https://www.ncbi.nlm.nih....

No competing interests declared.