Arch Pediatr Adolesc Med
 2009
DOI: 10.1001/archpediatrics.2008.524
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Minimal Risk in Pediatric Research as a Function of Age

David Wendler
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Cited by 22 publications

(6 citation statements)
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“…According to Edwards (Edwards, 2012), minimal risk is commonly described as brief pain from a small abrasion or wound, injections, or from common medical procedures where the probability of harm is no more than one would encounter in daily life. Some researchers have concluded that the definition of low risk differs between a healthy population of study and a clinical population of study (Wendler, 2009). We note that the pressure pain youth experienced in our study was no more severe than that commonly induced during routine clinical examination, physiotherapy, and routine motions/tasks following surgery (i.e., moving from bed to toilet or bath).…”
Section: Discussionmentioning
confidence: 99%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
“…According to Edwards (Edwards, 2012), minimal risk is commonly described as brief pain from a small abrasion or wound, injections, or from common medical procedures where the probability of harm is no more than one would encounter in daily life. Some researchers have concluded that the definition of low risk differs between a healthy population of study and a clinical population of study (Wendler, 2009). We note that the pressure pain youth experienced in our study was no more severe than that commonly induced during routine clinical examination, physiotherapy, and routine motions/tasks following surgery (i.e., moving from bed to toilet or bath).…”
Section: Discussionmentioning
confidence: 99%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
“…United States regulations limit non-therapeutic research that carries more than minimal risk (Wendler 2009). The current data are consistent with MRI being a minimal risk procedure, at least based on the psychological reactions to the procedure.…”
Section: Discussionmentioning
confidence: 99%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
“…It is not clear whether the risks posed in CTIMPs are sufficiently and proportionately greater than those encountered in clinical practice to justify universal testing. It has been suggested that older children with decision-making capacity should be able to take part in research that bears greater risks than the minimal risk standard for younger children provided they understand it and agree to participate 14 15. Implementation of this proposal might enable them to forego pregnancy testing when there is a perceived low risk of the treatment to pregnancy or fetus.…”
Section: Ethical Considerationsmentioning
confidence: 99%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
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