Facilitated Review of Research for NCI Pediatric Central IRB-Approved Research Protocols- PRO149   

Procedure
 

The purpose of this procedure is to outline the procedures for the institutional review of protocols when relying on an external Institutional Review Boards for research conducted at the University of Alabama at Birmingham (UAB) and Children’s of Alabama (CoA).

Investigator Responsibilities

The Investigator:

• Follows external IRBs requirements for working with the external IRB, including submission of any additional forms;
• Completes GUI320 Institution Review Form – Relying on External IRB and provides institutionally required documents listed on the form;
• Incorporates UAB-required language into the sponsor’s model consent form;
• Submit changes in study personnel to the OIRB;
• Reports reportable problems that occur locally to the UAB IRB (see POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB, PRO106 UAB Procedure to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB) and the external IRB;
• Tracks the protocol status (i.e., amendment, unanticipated problems involving risks to subjects or others which includes serious adverse events, and continuing reviews); and
• Reports continuing review approvals to the OIRB.

OIRB Responsibilities

The (designated) Reviewing Staff:

• Follows external IRBs requirements for working with the external IRB, including submission of any additional forms;
• Receives, reviews, and provides sign off for the Institution Review Form – Relying on External IRB;
• Receives and reviews submissions of continuing review approvals by the external IRB;
• Reviews problem reports (see POL006, PRO106); and
• Notifies the external IRB immediately if protocol is suspended or terminated.

IRB Responsibilities

The IRB:

• Reviews problem reports (see POL006, PRO106).