CommentaryMinimal risk in pediatric research
Section snippets
Minimal risks and the risks of daily life
The US regulations define “minimal” risks as risks that do not exceed the level of risks children ordinarily encounter in daily life or during the performance of routine physical or psychological tests (45CFR46 102 i). According to the widely endorsed “objective” interpretation, this standard refers to the risks present in the daily lives of average healthy children.1, 7 Although more data are needed, current data suggest that risk of death from riding in cars in the United States is 0.7 per 1
The magnitude of harms and seriousness of risks
Risks represent the probability that an individual will experience certain harms as the result of participating in a given activity. The “seriousness” of the risk is a function of the magnitude of the possible harm, together with the likelihood of experiencing that harm as a result of participating in the activity in question. For example, the seriousness of the risk of breaking a bone while riding a bicycle is a function of the magnitude of the possible break, together with the likelihood that
Comparative analysis applied to “407” studies
Under Section 407 of the US regulations, pediatric studies deemed to have important value but to pose risks too high for IRB approval may be approved by the Secretary of the Department of Health and Human Services after publication in the Federal Register and review by a panel of experts. As of November 2005, the Office for Human Resource Protections website had provided descriptions for 9 of the 17 studies that had been submitted for possible approval under Section 407 (//www.hhs.gov/ohrp/children/
Discussion
Pediatric studies submitted for possible approval under Section 407 of the US regulations offer a unique opportunity to assess how IRBs implement the federal minimal risk standard in practice. As of November 2005, data were publicly available on 9 of these 17 studies. Comparing the risks posed by the studied interventions to the risks that average, healthy children face in daily life reveals that 8 of these 9 studies categorized by the reviewing IRB as greater than minimal risk in fact pose
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Can transcranial electrical stimulation improve learning difficulties in atypical brain development? A future possibility for cognitive training
2013, Developmental Cognitive NeuroscienceCitation Excerpt :In order to protect paediatric participants from any potential harm that could be caused by TES in research, minimal risk standards need to be established by review boards. The risk exposure should be based on weighing possible negative consequences against the benefit for the individual child (Wendler and Varma, 2006). Cohen Kadosh and colleagues discuss the subject of ethics in child brain stimulation in more detail (Cohen Kadosh et al., 2012b) and offer several potential solutions to issues arising from bringing TES into clinical settings.
Diversified harmony: Supranational and domestic regulation of pediatric clinical trials in the European Union
2011, Journal of Cystic FibrosisPediatric Biobanks: Approaching Informed Consent for Continuing Research After Children Grow Up
2009, Journal of PediatricsCitation Excerpt :When these criteria have been satisfied, and investigators cannot locate adult individuals to obtain their consent for ongoing use of these samples/data, waiving the requirements to obtain informed consent from those individuals is ethically reasonable We believe that in many contexts, this continuing research can be considered “minimal risk.” We appreciate that although such determinations of risk levels in pediatrics have both normative and empirical dimensions and remain contested,34 the likelihood of even moderate harms appears to be sufficiently remote to consider many projects with stored tissues to be minimal risk. However, even when an institutional review board decides affirmative consent is not required (ie, can be waived), it may still be ethically preferable to attempt to obtain consent from subjects who can be located.
Minimal Risk, Yet Again
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2018, Health Care AnalysisClarifying the concept of the “Social” in risk assessments for human subjects research
2018, Accountability in Research
The opinions expressed herein are the authors’ own. They do not represent any position or policy of the National Institutes of Health, Public Health Service, or Department of Health and Human Services. This work was completed as part of the authors’ official duties as employees of the NIH Clinical Center. The authors have no financial conflicts of interest with respect to this manuscript or its contents.