Chapter

<b> <i>Research not Otherwise Approvable: A Look at One 407 Protocol</i> </b>

Lainie Friedman Ross

in Children in Medical Research

Published in print February 2006 | ISBN: 9780199273287
Published online May 2006 | e-ISBN: 9780191603655 | DOI: http://dx.doi.org/10.1093/0199273286.003.0015

Series: Issues in Biomedical Ethics

  Research not Otherwise Approvable: A Look at One 407 Protocol

Show Summary Details

Preview

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

Chapter.  7227 words. 

Subjects: Moral Philosophy

Full text: subscription required

How to subscribe Recommend to my Librarian

Buy this work at Oxford University Press »

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.