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Commentary
Questioning the ethics of international research on formula milk supplementation in low-income African countries
  1. Tanya Doherty1,2,3,
  2. Ingunn Marie S Engebretsen4,
  3. Thorkild Tylleskär4,5,
  4. Kathy Burgoine6,
  5. Anne Baerug7,
  6. Raul Mercer8,
  7. Phillip Baker9,
  8. David Clark10,
  9. Catherine Jane Pereira-Kotze2,
  10. Max Kroon3,11
  1. 1Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa
  2. 2School of Public Health, University of the Western Cape Faculty of Community and Health Sciences, Cape Town, South Africa
  3. 3Department of Paediatrics and Child Health, University of Cape Town, Faculty of Health Sciences, Observatory, Western Cape, South Africa
  4. 4Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
  5. 5Centre for Intervention Science in Maternal and Child Health, University of Bergen, Bergen, Norway
  6. 6Neonatal Unit, Mbale Regional Referral Hospital, Mbale, Uganda
  7. 7Unit on Breastfeeding, Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway
  8. 8Program of Social Sciences and Health, Latin American School of Social Sciences (FLACSO), Buenos Aires, Argentina
  9. 9Institute for Physical Activity and Nutrition, Deakin University, Geelong, Victoria, Australia
  10. 10Giovine-Clark Consultancy, Independent, New York, New York, USA
  11. 11Neonatal Service, Mowbray Maternity Hospital, Mowbray, South Africa
  1. Correspondence to Professor Tanya Doherty; tanya.doherty{at}mrc.ac.za

https://doi.org/10.1136/bmjgh-2022-009181

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    Summary box

    • The increase in funding for priority public health issues largely affecting low/middle-income countries (LMICs) has led to the growth in international research involving researchers or research sponsors from a high-income country conducting research in LMICs.

    • Several ethical guidelines specifically addressing international research have been published, yet we still find examples of research undertaken by high-income country principal investigators and funders with no benefit and large potential for harm, being undertaken in LMICs.

    • In this commentary, we provide an example from a trial of formula milk supplementation in Uganda and Guinea-Bissau and outline ways in which this trial violates basic ethical principles and human rights and has zero potential for scale-up within the research settings.

    • Appropriate, safe and scalable alternatives to formula milk supplementation of low birthweight newborns should be prioritised including zero separation of mothers and newborns, lactation support and human milk banks.

    • We challenge LMIC institutional review boards, research funders, clinicians, scientists and governments to carefully consider potential maleficence, especially if an intervention is not scalable locally, and exercise their responsibility to protect their citizens from unethical international health research.

    Over the past three decades, the increase in funding for priority public health issues largely affecting low/middle-income countries (LMICs) has led to the growth in international research involving researchers or research sponsors from a high-income country (HIC) conducting research in LMICs. The ethical considerations in such international research were raised in the 1990s and several ethical guidelines specifically addressing international research were published.1 2 However, in 2022, we still find examples of research undertaken by HIC principal investigators and funders, with no benefit and large potential for harm, being undertaken in LMICs.

    A randomised controlled trial that began recruiting in February 2021 is nearing completion in Uganda and Guinea-Bissau3 of formula supplementation of breastfed newborns for 30 …

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