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Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research
American Journal of Bioethics 20 (4):8-10 (2020)
Abstract
The regulations dictating acceptable levels of risk in pediatric research were developed to protect pediatric research participants from unnecessary or excessive harms. These special protections we...Author's Profile
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Citations of this work
The “Risks of Routine Tests” and Analogical Reasoning in Assessments of Minimal Risk.Adrian Kwek - 2024 - Journal of Medicine and Philosophy 49 (1):102-115.
References found in this work
Greater Than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations.Benjamin S. Wilfond, Devan M. Duenas & Liza-Marie Johnson - 2020 - American Journal of Bioethics 20 (4):102-103.
Bringing Known Drugs to Pediatric Research: Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk.Akshay Sharma & Liza-Marie Johnson - 2020 - American Journal of Bioethics 20 (4):106-108.
Ethical Drug Development for Rare Childhood Diseases: When There Are Limited But Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?Liza-Marie Johnson, Devan M. Duenas & Benjamin S. Wilfond - 2020 - American Journal of Bioethics 20 (4):111-113.
Balancing Scientific Progress With Pediatric Protections: No Direct Benefit Now, But Potential Novel Therapy in the Future.Susannah W. Lee & Jessica C. Ginsberg - 2020 - American Journal of Bioethics 20 (4):108-110.
Autism Advocacy Before and After DSM-5.Ryan H. Nelson - 2020 - American Journal of Bioethics 20 (4):48-50.
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