Review of Modifications to Research at Convened IRB Meetings- PRO144   

OIRB Responsibilities

Administrative Staff:

• Assigns Primary Reviewer(s) using the list of members (including alternates) selected for the convened IRB meeting (see PRO143 Procedure for IRB Member Selection for Convened Meeting):
  • Assigns, optimally, three members to review each submission  as follows:
    • At least one physician scientist or non-physician scientist 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 Reviewer(s) assignment in development of convened IRB agenda for initial and continuing review, and review of modifications of protocols

IRB Responsibilities

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 as the Reviewer(s) for a convened IRB meeting:

• Reviews each protocol and associated materials assigned to the Primary Reviewer(s) in sufficient depth for oral presentation at meeting
• Reviews all materials assigned to each IRB member for discussion at the meeting