• Discuss how the results might have been affected if the comparison group was:
ID: 123296 • Letter: #
Question
• Discuss how the results might have been affected if the comparison group was: (1) no milk instead of non-fortified milk; (2) milk fortified with other nutrients besides those being investigated in the study. • Do you see any ethical issues in this study in terms of equipoise? • Discuss the meaning of informed consent in vulnerable or underage populations. Can truly informed consent ever be obtained in these populations? How would you as a study investigator make sure that patients enrolled in the study were fully informed? What elements should go into an informed consent in this type of study?
Explanation / Answer
* Milk is well accepted as a meansof delivery of micronutrients.So if the study group were no milk consuming children and those supplimented with fortified milk, the result would be same as the children supplimented with fortified milk would have more immunity than the other group. Also those who never consume milk would have more prone to get diarrhea, pnuemonia and other infectious diseases.
Deficiency of specific micronutrients predispose children to common childhood infections. Fortified milk is well accepted as an intervention to deliver specific micronutrients with sustained compliance.Hence, besides the investogated nutrients, if other more nutrients addes would bring more positive results in children's health.
* Thechildren in the study were similar age group and socioeconomic background. so there was no ethical issues noted.
*Informed consent is the written statement which is clearly written in the participants understanding language and would be signed before theparticipation of study.In case of vulnarable or under age population, they arenot supposed to sign the consent legally. In suc cases, the parents or care taker or guardien ofvthe participant is legallly responsoble to sign it.
*A child cannot give legal consent to participate in research, so the investigator should speak the parent s for consent , but their children give their assent , where appropriate. A full information about the nature of research should be provided to them before starting the study. A prior questionnair might help the investigator to evaluate the awareness of the participant about the study.
*The informed consent clearly explain what is required of child as what is asked of the parent. The document should also clearly state if there is to be future contact with the family or if there will be any observation or interactions with the child while the parent is not present. Also the script shou'd clearly state what the child is being asked to do, where, for how long, and with whom , and the nature of the study.
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