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<h2 class="hd hd-2 unit-title">Part I</h2>
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<p>In this exercise, we return to the malnutrition case from the Module 2 exercise. </p>
<p>Globally, malnutrition in children under 5 years of age remains a significant problem. About 16% or 95 million children under 5 years of age in low-income settings were underweight (had low weight for their age) in 2014. You are working with researchers in Rajasthan, India and would like to design a study to assess the percentage of children under 5 years of age who are underweight and/or stunted (have low height-for-age) in the state as well as factors that are associated with being malnourished. </p>
<p>The team decides to conduct a cross-sectional survey in sampled households across the state to assess malnutrition in children under 5 years of age. The study will involve the following elements: 1) a questionnaire administered by interviewers to the children’s primary caregiver 2) collection of anthropometric data: height, weight and mid upper arm circumference (MUAC) of children under 5 years of age</p>
<p>In designing the study protocol and during implementation of the data collection, the team must consider a number of ethical issues.</p>
<p></p>
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Question 1
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<p>Will the study protocol for this research require approval from one or more institutional review boards (IRBs)?</p>
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<p>Why or why not?</p>
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Question 3
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<p>What materials would be required as part of the IRB application? (Select all that apply)</p>
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Question 4
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<p>The research team prepares a draft informed consent form that explains the objective of the study, its duration, as well as the nature of the questionnaire and anthropometric measurements. What other key elements should be included in the consent form? (Select all that apply)</p>
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Question 5
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<p>The final versions of the study protocol, informed consent and other documents are submitted to the appropriate IRB and after review, are approved. The informed consent process as described in the protocol involves obtaining written consent from the primary caregiver in each household. However, when data collection begins, it is clear that the majority of the target population is illiterate and unable to provide written consent. Your colleagues decide to obtain verbal consent from these participants instead of written consent and to continue on with the data collection uninterrupted. Do you agree or disagree with your colleagues&#8217; decision?</p>
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Question 6
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<p>Explain your rationale for your answer to question 5.</p>
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