Home

Climate Change Project

Table of Contents

Courses

Search


<< >> Up Title Contents
Research Not Otherwise Approvable


HHS will conduct or fund research that the IRB does not believe meets the requirements of ... [these regulations] only if:

(a)
The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b)
The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either: (1) That the research in fact satisfies the conditions of ... [these regulations] as applicable, or (2) the following: (i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; (ii) The research will be conducted in accordance with sound ethical principles; and (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in [these regulations]. (sec. 45 CFR 46.407)


<< >> Up Title Contents

Law and the Physician Homepage
Copyright 1993 - NOT UPDATED

The Law, Science & Public Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation

See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster