A graduate student proposed to ask a random sample of 100 persons in shopping mall about their daily nutrition. They were asked what they typically ate for breakfast, lunch, and evening meal, and whether they indulged in snacks to a significant degree. They were also asked why their diet was composed as described. Age, sex, approximate height and weight information was also collected. During the discussion in the IRB a member objected that, in his opinion, the questions were so general and the correlational data so skeletal that the research could not be generalized and, accordingly, was a useless waste of subjects' time. The protocol was reviewed under Standard Review because it was intended that minors, if in the company of parents or guardians, be included in the subject pool.
It was finally agreed that the risks to properly informed human subjects were negligible. The risk-benefit ratio therefore took on the character of being a search for even the slightest form of benefit either to the subjects or as an increment of useful human knowledge. That being the case, the IRB directed that the informed consent document accurately describe the purpose of the research in the light of the improbability of significant correlations. It was agreed that, however unlikely, the study could turn up unexpected results at a statistically significant level and, in this sense, was a beneficial probe of the respondants. Without prejudicing the results the IRB had requested that the researcher set an accurate frame of reference in which potential subjects could establish their own risk - benefit analysis and decision.
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