Cases in Bioethics: Health Research Ethics in Southeast Asia
Keywords

incentives, placebo, nutrition, randomized controlled trial, children

Micronutrients, which include minerals and vitamins, are important components in a child’s growth and neurodevelopment.1 Deficiencies in these dietary substances create a challenge to child health in many low- and middle-income countries. Micronutrient deficiencies can cause physical and cognitive impairment, susceptibility to infections, and even death.2 In 2019, the United Nations International Children's Emergency Fund reported that globally, nearly 45% of children between 6 months and 2 years of age did not eat any fruits or vegetables, the main source of micronutrients.

A state health department in a Southeastern Asian country is conducting a research study in collaboration with a company that makes packets of micronutrient supplements containing iron, folate, zinc, iodine, vitamin A, vitamin D, and vitamin B12—at roughly 1.5 to 2 times the recommended daily allowance for each micronutrient. The goal is to examine the effectiveness of micronutrient supplements on growth, neurodevelopment, and hemoglobin levels in children from that state. Also on the research team is the primary care doctor who supervises several child health clinics in the state.

The researchers recruited children up to 2 years of age attending a child health clinic for routine vaccinations scheduled as part of the national immunization program. The nurse in charge of vaccination for the day obtained consent from the children’s parents. After obtaining consent, the researchers randomized the participants into two groups. One group received a daily packet of powdered micronutrients for 12 months, and the other received a packet of similar weight and color that contained no micronutrients for the same time period. All parents received nutritional education from the study dietician at the beginning of the study and after 6 months. Those who did not wish to participate in the study were referred to a dietician only when determined necessary by the clinic. Children participants were monitored every 3 months for weight and height, anemia and neurodevelopment as assessed by an evidence-based tool, the Bayley Scales of Infant and Toddler Development. During the year-long study, parents returned every 3 months for micronutrient packets, would complete a study questionnaire, and received a cash voucher for an online grocery store.

Questions

  1. Is a randomized control trial an ethically appropriate study design for the above study? Why or why not? What ethical justification is required for use of a placebo arm?

  2. What ethical concerns might you have about recruitment and informed consent concerning this study? How might you address them?

  3. How might the researchers ensure that the health and safety of all children is addressed appropriately?

  4. Was it appropriate for participants to be provided with cash vouchers? Why or why not?

References

Centers for Disease Control and Prevention. “Micronutrient Facts.” Centers for Disease Control and Prevention. April 30, 2018. https://www.cdc.gov/nutrition/features/micronutrient-facts.html?CDC_AAref_Val=https://www.cdc.gov/nutrition/micronutrient-malnutrition/micronutrients/index.html.
Multisectoral Action in Food Systems, Nutrition and Food Safety. Guidelines on Food Fortification with Micronutrients. Edited by Lindsay Allen, Bruno de Benoist, Omar Dary, and Richard Hurrell. Geneva: World Health Organization, 2006.
Tam, Emily, Emily C. Keats, Fahad Rind, Jai K. Das, and Zulfiqar A. Bhutta. “Micronutrient Supplementation and Fortification Interventions on Health and Development Outcomes among Children Under-Five in Low- and Middle-Income Countries: a Systematic Review and Meta-Analysis.” Nutrients 12, no. 2 (January 21, 2020): 289. https://doi.org/10.3390/nu12020289.

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