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

Abstract:
This procedure outlines the responsibilities of the investigator, OIRB and IRB for facilitated review of research for NCI pediatric central IRB-approved research protocols.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO149
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure for Facilitated Review of Research for NCI Pediatric Central IRB-Approved Research Protocols

PROCEDURE

The purpose of this procedure is to describe the University of Alabama at Birmingham (UAB) and The Children’s Hospital of Alabama (TCHA) participation in the National Cancer Institute Central Pediatric IRB (NCI Pediatric CIRB) initiative for Pediatric CIRB collaborative oncology trial reviews.

Investigator Responsibilities

The Investigator:

  • Submits all approved protocol specific documents from the NCI Pediatric CIRB website (www.ncicirb.org);
  • Revises the consent form document in accordance with the UAB IRB consent form template;
  • Completes GUI320 UAB IRB-NCI Pediatric CIRB Submission Checklist providing institutionally required documents listed on the web site (www.uab.edu/irb);
  • 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 NCI Pediatric CIRB;
  • Tracks the protocol status (i.e., amendment, unanticipated problems involving risks to subjects or others which includes serious adverse events, and continuing reviews posted to the NCI CIRB web site);

IRB Responsibilities

The Pediatric CIRB Facilitated Review Subcommittee (Chair, Vice-Chair, or designated member):

  • Reviews the protocol materials;
  • Assures NCI Pediatric CIRB-approved protocol maintains compliance with state, local or institutional requirements;
  • Takes one of the following actions:
    • Accepts NCI Pediatric CIRB review and revised consent form. Minor changes may be made in formatting, UAB language or HIPAA;
    • Rejects the NCI Pediatric CIRB review and/or consent form. The UAB IRB may not modify any of the NCI CIRB-approved language in the consent form. If consent modifications are deemed crucial, the NCI Pediatric CIRB review will be rejected. The reviewer will document the rationale for the decision and refer the protocol for review by the standard UAB IRB process and notify the investigator.

OIRB Responsibilities

The (designated) Senior Staff:

  • Reports to NCI Pediatric CIRB and the investigator the IRB decision to accept or reject the CIRB review using the Facilitated Review Acceptance Form which is submitted electronically;
  • Reviews e-mail notifications from NCI Pediatric CIRB of protocol status (i.e., amendment, SAE and continuing reviews);
  • Reviews problem reports (see POL006, PRO106);
  • Notifies the NCI Pediatric CIRB immediately if protocol is suspended or terminated.


Approved on March 23, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director