Effects of federal human subjects regulations on data obtained in environmental stressor research.
A series of experiments on environmental noise was performed over a 3-year period. Those experiments in the series that incorporated federal subjects guidelines concerning informed consent failed to replicate the negative aftereffects of noise found earlier by Glass and Singer. The experiments that were performed before implementation of the federal guidelines, however, successfully replicated the Glass and Singer findings. To clarify this pattern of results, a final experiment was performed on two groups of subjects treated identically except that one group gave informed consent while the other did not. The results confirmed that the subject procedures involving informed consent as defined by the federal guidelines prevent the emergence of negative aftereffects of noise, possibly because these procedures give the subjects what amounts to control over the stressor. Similar phenomena may occur in research on other environmental stressors, such as crowding and electric shock, in which subject's perception of control is a critical variable. Possible techniques for performing future research of this type are discussed.
D001288:Attention; D035841:Behavioral Research; D035082:Federal Government; D005260:Female; D006077:Government Agencies; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent; D008297:Male; D009622:Noise / Q000009:adverse effects*; D012106:Research; D014481:United States