4.5 Local 407 Panel Review of Pediatric Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for convening a local 407 Panel to consider pediatric research which is not federally funded or FDA regulated.


2.0 Policy

It is the policy of the Organization that research involving minors which is neither funded by HHS nor regulated by FDA, and which presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children but does not meet the requirements of HHS regulations at 45 CFR 46.404, 46.405, or 46.406 may be reviewed by a local 407 panel.


3.0 Definitions


4.0 Eligibility for Local 407 Panel Review


5.0 Local 407 Panel Membership


6.0 407 Panel Review


7.0 Full IRB Review


DOCUMENT HISTORY:

 Written: 1/28/2016 (Approved: 1/28/2016) - original author not recorded

 Revised: 2/19/2018 - revision not documented


Revision #6
Created 24 October 2019 21:36:59 by Autumn M Eberly
Updated 7 September 2023 02:32:50 by Robert A Lewis