Jump to ContentJump to Main Navigation
Children in Medical ResearchAccess versus Protection$
Users without a subscription are not able to see the full content.

Lainie Friedman Ross

Print publication date: 2006

Print ISBN-13: 9780199273287

Published to Oxford Scholarship Online: May 2006

DOI: 10.1093/0199273286.001.0001

Show Summary Details
Page of

PRINTED FROM OXFORD SCHOLARSHIP ONLINE (www.oxfordscholarship.com). (c) Copyright Oxford University Press, 2018. All Rights Reserved. Under the terms of the licence agreement, an individual user may print out a PDF of a single chapter of a monograph in OSO for personal use (for details see www.oxfordscholarship.com/page/privacy-policy).date: 13 December 2018

Research not Otherwise Approvable: A Look at One 407 Protocol

Research not Otherwise Approvable: A Look at One 407 Protocol

Chapter:
(p.243) 14 Research not Otherwise Approvable: A Look at One 407 Protocol
Source:
Children in Medical Research
Author(s):

Lainie Friedman Ross (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/0199273286.003.0015

CFR section 46.407 of Subpart D of the federal regulations addresses research that is not otherwise approvable. Research is not otherwise approvable because either (1) it seeks to enroll healthy children, but offers no prospect of direct benefit and entails more than minimal risk; or (2) it seeks to enroll children with a disorder or condition, but offers no prospect of direct benefit and entails more than a minor increase over minimal risk. According to CFR section 46.407, such research can be permissible if it is reviewed and approved by a panel of experts convened by the secretary of the Department of Health and Human Services. The regulations also require public review of the research. Prior to the year 2000, only two panels of experts were convened. This chapter examines the University of Washington’s experience with its protocol, Precursors to Diabetes in Japanese American Youth, as a case study of the strengths and limitations of the 407 process in 2001.

Keywords:   diabetes research, Japanese American children, Code of Federal Regulations, 407 protocol

Oxford Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.

Please, subscribe or login to access full text content.

If you think you should have access to this title, please contact your librarian.

To troubleshoot, please check our FAQs , and if you can't find the answer there, please contact us .