Library Document Details

Procedure for Formation and Assignment of IRB Member Primary Review Teams for Initial or Continuing Review or Review of Modifications to Research at Convened IRB Meetings - IRB PRO144

Abstract:
This procedure outlines the responsibilities of the OIRB and IRB for formation and assignment of IRB member primary review teams for initial or continuing review or review of modifications to research at convened IRB meetings.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO144
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure for Formation and Assignment of IRB Member Primary Review Teams for Initial or Continuing Review or Review of Modifications to Research at Convened IRB Meetings

PROCEDURE

OIRB Responsibilities

Administrative Staff:

  • Assigns members to a Primary Review Team, subjectively, using the list of members (including alternates) selected for the convened IRB meeting (see PRO143 Procedure for IRB Member Selection for Convened Meeting):
    • Forms at least three Primary Review Teams for each convened meeting;
    • Assigns, optimally, three members to each Primary Review Team as follows:
      • At least one physician scientist or non-physician scientist to each Primary Review Team;
      • At least one member who does not have a scientific background, whenever possible;
      • At least one member who does not have an affiliation with UAB, whenever possible;
  • Uses Primary Review Team assignment in development of convened IRB agenda for initial and continuing review, and review of modifications of protocols.

IRB Responsibilities

The Chair (or designee):

  • Examines the agenda for each meeting to determine if a consultant is needed for:
    • Scientific expertise;
    • Representation of vulnerable populations;
    • Understanding of local context;
    • Other issues.
  • Appoints consultants as necessary for research protocols to receive adequate review.

IRB Member assigned to a Primary Review Team for a convened IRB meeting:

  • Reviews each protocol and associated materials assigned to the Primary Review Team in sufficient depth for oral presentation at meeting;
  • Reviews all materials assigned to each IRB member for discussion at the meeting.

Approved on March 23, 2007, by: 

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director