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The survey found significant misclassification by IRBs of studies felt to be ‘‘exempt’’ from IRB review. Another survey of IRB chairs who frequently assessed studies involving children noted wide variations in the definitions the IRBs used for interventions constitution ‘‘minimal’’ or ‘‘minor increase over minimal’’ risk (Shah, Whittle, Wilfond, Gensler, & Wendler, 2004). A recent study showed large differences between IRBs in how they required investigators to respond to federal regulations regarding child assent to participation in research (Whittle, Shah, Wilfond, Gensler, & Wendler, 2004), while a review of IRB websites revealed some ‘‘incorrect advice’’ to investigators about meeting regulatory requirements concerning children (Wolf, Zandecki, & Lo, 2005).

By examining the data as it is collected, the researcher will become familiar with its informational content, and may identify new topics to be explored and develop analytic hunches and connections that can be tested as analysis progresses. These insights also inform subsequent data collection. For example, a question might be added to the interview guide to explore a new topic with a subsequent interviewee. Although this chapter presents content analysis as a series of sequential steps, it is important to note that it is an inherently iterative process.

As compared to quantitative inquiry, the goal of all qualitative inquiry is to understand a phenomenon, rather than to make generalizations from the study sample to the population based on statistical inference. , decision-making, delivery of health care services); capturing the views, motivations, and experiences of participants; and explaining the meaning they make of those experiences. When used as part of a study or series of studies using a combination of qualitative and quantitative methods, qualitative methods can be employed to explain the quantitative results and/or to generate items for a closed-ended survey.

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