vulnerability, assent, inducements, nutrition, clinical trial, minors
Nutritional supplementation for children in developing countries is thought to be important for particular groups and conditions, but additional scientific evidence is needed to guide practices. Recognizing that it is not always possible to extrapolate findings from adults to children because of physiological and other differences, inclusion of children in nutritional research is needed to support safe and effective supplementation.
Researchers at a university in Malaysia received grant funding from an international nutritional supplement company to study the effects of dietary supplementation in preadolescent children. The researchers recruited prepubertal boys and girls (between 7 to 12 years old) from three urban public schools to participate in a double-blind, randomized controlled trial. Children eligible for the trial were healthy as determined by a standardized pediatric assessment, willing to comply with the study procedures, and provided assent. Written informed consent was obtained from parents or legal guardians.
During the 1-year study period, the researchers provided participants with supplements in packets to be mixed into a drink. Control, or placebo, versions of the sachets were identical in both appearance and taste. Parents or legal guardians were asked to monitor consumption of the study drink and record intake using a diary. The research team drew 10 milliliters of blood at three time points: at baseline, 6 months, and 12 months. To encourage compliance and retention of participants, the researchers offered incentives such as paying for school fees, textbooks and supplies, and sports equipment. The protocol was approved by a research ethics committee (REC), and the trial was registered in ClinicalTrials.gov.
As the study proceeded, additional parents became interested in enrolling their children in the study. The researchers grew concerned that this uptick in interest arose from financial incentives. Administrators of the public school system also openly requested financial incentives from the research team.
Questions
Malaysia’s research ethics guidelines state that assent for minors younger than 7 years old is not required, as these children are considered incapable of fully understanding the research process. However, assent for minors 7 to 18 years old is required, as in this case study. How would you respond to parents who requested that their child be recruited into this study if the child expresses hesitancy?
Apart from the REC, are there others who should be engaged in order to seek their input or approval for this study?
When is it ethically acceptable to recruit minors for a placebo-controlled study? What features of the study or population would warrant use of a placebo for research with minors?
What, if any, concerns do you have related to the incentives being provided to parents/guardians and children for this study? How would you respond to the administrators of the public schools who requested financial incentives?
