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Editorial
. 2020 May;20(4):8-10.
doi: 10.1080/15265161.2020.1735868.

Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research

Devan M Duenas  1 , Benjamin S Wilfond  1   2 , Liza-Marie Johnson  3
Affiliations
Editorial

Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research

Devan M Duenas et al. Am J Bioeth. 2020 May.
No abstract available

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References

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    1. Food and Drug Administration (FDA). 2019. Electronic Code of Federal Regulations. 21 CFR 50. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?C... (accessed January 14, 2020)
    1. Janofsky J, and Starfield B. 1981. Assessment of risk in research on children. The Journal of Pediatrics 98(5): 842–846. doi: 10.1016/S0022-3476(81)80865-7. - DOI - PubMed
    1. Johnson LM, Duenas DM, and Wilfond BS. 2020. Ethical drug development for rare childhood diseases: When there are limited but promising data in adults, how to choose between safety or efficacy studies? The American Journal of Bioethics 20(4): 102–103. - PMC - PubMed
    1. Lee SW, and Ginsberg JC. 2020. Balancing scientific progress with pediatric populations: No direct benefit now, but potential novel therapy in the future. The American Journal of Bioethics 20(4): 108–110. - PubMed

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