Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research
Abstract
THE AMERICAN JOURNAL OF BIOETHICS 2020, VOL. 20, NO. 4, 8–10 https://doi.org/10.1080/15265161.2020.1735868 EDITORIAL Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research a a,b c Devan M. Duenas , Benjamin S. Wilfond , and Liza-Marie Johnson a b c Seattle Children’s Research Institute; University of Washington School of Medicine; St. Jude Children’s Research Hospital The regulations dictating acceptable levels of risk in of 45 CFR 46 were not changed. The two case studies pediatric research were developed to protect pediatric in this issue focus on circumstances when IRBs are research participants from unnecessary or excessive being asked to consider the approvability of drug harms. These special protections were adopted in 1983 studies with pediatric populations who are not by the Department of Health and Human Services expected to directly benefit based on current study (DHHS) as part of what is generally referred to as design. Here the regulations dictate that “Clinical Subpart D of the Common Rule (DHHS 2018), and investigations involving greater than minimal risk and have not undergone any evaluation or substantive revi- no prospect of direct benefit to individual subjects, sion in over 35 years. As pathways for