Harmonization of Ethics Policies in Pediatric Research

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed over 20 years ago with a goal of harmonizing research regulations among the European Union, United States, and Japan. Harmonization was intended to speed approval of pharmaceuticals, avoid unnecessary repetition of studies, and ensure protection of research participants. This paper examines United States, European Union, and ICH pediatric research regulations in five domains: parental permission, assent/dissent, payment, risk/benefit and inclusion of disabled children/wards of state. The purpose is to examine similarities and differences among the regulations to help investigators, policy makers and the public to understand what each regulatory framework can learn from the others. Additionally, the paper suggests philosophical differences in how these entities view pediatric research which may serve as barriers to harmonization in the future
Keywords No keywords specified (fix it)
Categories (categorize this paper)
 Save to my reading list
Follow the author(s)
My bibliography
Export citation
Find it on Scholar
Edit this record
Mark as duplicate
Revision history Request removal from index
Download options
PhilPapers Archive

Upload a copy of this paper     Check publisher's policy on self-archival     Papers currently archived: 9,360
External links
  • Through your library Configure
    References found in this work BETA
    Citations of this work BETA
    Similar books and articles
    David Wendler (2004). Risk Standards for Pediatric Research: Rethinking The. Kennedy Institute of Ethics Journal 14 (2):187-198.

    Monthly downloads

    Added to index


    Total downloads

    4 ( #198,645 of 1,089,153 )

    Recent downloads (6 months)

    1 ( #69,735 of 1,089,153 )

    How can I increase my downloads?

    My notes
    Sign in to use this feature

    Start a new thread
    There  are no threads in this forum
    Nothing in this forum yet.