4 found
  1.  16
    Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization.Jamie Webb, Lesha D. Shah & Holly Fernandez Lynch - 2020 - American Journal of Bioethics 20 (9):4-17.
    Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research....
    Direct download (2 more)  
    Export citation  
    Bookmark   14 citations  
  2.  3
    Siblings and Discordant Eligibility for Gene Therapy Research: Considering Parental Requests for Non-Trial "Compassionate Use”.Jamie Webb, Lesha D. Shah & Alison Bateman-House - forthcoming - Clinical Ethics:147775092098357.
    Deciding whether to grant an expanded access request for a child whose sibling is enrolled in a gene therapy trial involves a number of complex factors: considering the best interests of the child, the psychosocial and economic impact on the family, and the concerns and obligations of researchers. Despite the challenges in coming to a substantively fair outcome in cases of discordant eligibility, creating a procedurally fair decision-making process to adjudicate requests is essential.
    Direct download  
    Export citation  
    Bookmark   2 citations  
  3.  20
    Preapproval Nontrial Access and Off-Label Use: Do They Meet Criteria for Dual-Deviation Review?Carolyn Riley Chapman, Kelly McBride Folkers, Andrew McFadyen, Lesha D. Shah & Alison Bateman-House - 2019 - American Journal of Bioethics 19 (6):22-25.
    Volume 19, Issue 6, June 2019, Page 22-25.
    Direct download (4 more)  
    Export citation  
  4.  2
    Fetal Therapies and Clinical Research: Beyond Risk and Benefit.Alison Bateman-House, Rafael Escandon, Andrew McFadyen, Cara Hunt, John Lantos & Lesha D. Shah - 2022 - American Journal of Bioethics 22 (3):1-3.
    Advancements in fetal assessment and therapeutic intervention in medical practice and clinical research call for corresponding progress in regulatory and ethical guidance. In “A new ethical framewo...
    No categories
    Direct download (3 more)  
    Export citation