Procedure for Documentation of Research Undergoing Initial or Continuing Review by the Expedited Procedure - IRB PRO136

Abstract:
This procedure outlines the responsibilities of the OIRB and the IRB for documentation of research undergoing initial or continuing review by the expedited procedure.
Effective Date:
3/1/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO136
Effective Date:   3/30/07
Revision Date:  3/1/10
Subject:  Procedure for Documentation of Research Undergoing Initial or Continuing Review by the Expedited Procedure

PROCEDURE

OIRB Responsibilities

The Administrative Staff:

  • Receives FOR200 Human Subjects Protocol (HSP), which lists permissible categories of research eligible for expedited review in materials for review;
  • Verifies research qualifies under one or more of the permission categories;
  • Verifies additional review has been obtained for DoD-sponsored research, if applicable (see GUI339);
  • Reviews protocol to identify any protocol specific findings required by local policy and applicable regulations;
  • Places a copy of all written communications to investigators of actions taken in protocol file;
  • Documents presentation to the convened IRB of research approved via expedited procedure.

IRB Responsibilities

The IRB Chair or designee:

  • Documents proposed research meets permissible category for expedited review;
  • Documents review does or does not meet approval criteria;
  • Documents actions taken;
  • Documents protocol-specific findings by local policy and regulations, as applicable, for:
    • Waiver or alteration of informed consent process;
    • Waiver of consent documentation;
    • Research including pregnant women or fetuses;
    • Research including children as subjects;
    • Research involving cognitively impaired adults.

Approved on March 1, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director