Ethics and Research with Children: A Case-Based Approach

By Eric Kodish | Go to book overview

2
Evaluating Benefits and Harms in Research on Healthy Children

Paul B. Miller and Charles Weijer

This chapter provides a case-based illustration of institutional review board (IRB) evaluation of the benefits and harms of research involving healthy children. We commence with a case description of a controversial study of airway hypoxia in healthy infants. Then, in the ethical analysis and discussion that follows, we identify issues raised by this study and explain why the relevant federal regulations require a conceptual framework for IRB implementation. We then provide a brief overview of component analysis, a systematic conceptual framework for IRB evaluation of benefits and harms in research. Next, we appeal to the airway hypoxia study to explain the implementation of component analysis, and illustrate that it usefully directs and governs IRB evaluation of research. Finally, we reflect further on the limitations of component analysis and its important contribution to effective IRB review.


CASE DESCRIPTION

A controversial study of airway hypoxia in infants (Parkins, Poets, O'Brien, Stebbens, & Southall, 1998) serves well to illustrate the challenges that IRBs face when evaluating the benefits and harms of research involving healthy children. The researchers in the study sought to investigate physiological responses to airway hypoxia (low oxygen) in infants. The question was: What happens to infants who are exposed to oxygen levels lower than the normal 21% fraction of inspired oxygen that exists in room air? The study was conducted on the basis of evidence suggesting that airway hypoxia, brought on by such circumstances as intercontinental air travel, may be associated with severe respiratory distress and sudden death in infants. Stimulated by reports of two infant deaths from sudden infant death syndrome (SIDS) shortly after intercontinental air travel, researchers hoped that the study would provide further insight on “the physiological effects of airway hypoxia on respiratory function in infants” (Parkins et al., 1998, p. 887).

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