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Human Subjects Division (HSD)

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Document Details

Last Updated 08/28/2015
Version 1.10
Filesize 56.76 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Policy

SOP Neonates

Purpose

This document describes the requirements and procedures for obtaining IRB approval of research involving neonates or neonates of uncertain viability. Viable neonates are considered children. Research involving viable neonates is therefore governed by the regulations and procedures for research involving children.

Change Notes

  • Related to Ver. 1.10, noted 08/28/2015 @ 04:54pm
    Clarifications regarding neonates, and neonates of uncertain viability as incidental populations.
    - sherrye
  • Related to Ver. 1.00, noted 11/01/2013 @ 12:28pm
    Document newly added.
    - sherrye