Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research-Reference-Cited by-同舟云学术

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

Published:2020-03-24 Issue:4 Volume:20 Page:8-10
ISSN:1526-5161
Container-title:The American Journal of Bioethics
language:en
Short-container-title:The American Journal of Bioethics

Author:

Duenas Devan M.¹^ORCID,Wilfond Benjamin S.¹²,Johnson Liza-Marie³^ORCID

Affiliation:

1. Seattle Children’s Research Institute;

2. University of Washington School of Medicine;

3. St. Jude Children’s Research Hospital

Publisher

Informa UK Limited

Subject

Health Policy,Issues, ethics and legal aspects

Link

https://www.tandfonline.com/doi/pdf/10.1080/15265161.2020.1735868

Reference14 articles.

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?CFRPart=50 (accessed January 14, 2020)

2. Assessment of risk in research on children

3. Ethical Drug Development for Rare Childhood Diseases: When There Are Limited But Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?

4. Balancing Scientific Progress With Pediatric Protections: No Direct Benefit Now, But Potential Novel Therapy in the Future

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