PROCEDURE

The purpose of this procedure is to describe the review of industry-sponsored protocols conducted at the University of Alabama at Birmingham (UAB) by Western IRB (WIRB) in Olympia, Washington.

The Investigator:

• Receives new protocols from the industry sponsor and decides to open the study;
• Checks the UAB IRB web site (www.uab.edu/irb) to obtain the required documents for submission to WIRB, including UAB required documents;
• Downloads, completes, and prints all documentation from the web site which may include:
  • GUI312 UAB-WIRB New Review Cover Letter/Checklist
  • WIRB Initial Review Submission Form
  • Other applicable documents (HIPAA Waivers, UAB required documents, etc.);
• Revises the industry sponsor consent form document per the UAB IRB/WIRB approved consent form template, including formatting and UAB-required language;
• Completes the New Review Cover Letter/Checklist providing WIRB and UAB required documents for submission including:
  • Facility Approvals;
  • Release of Drugs for Human Research Use (for UAB and/or TCHA);
  • Radiation Safety Approval, if applicable;
  • Infection Control Approval, if applicable;
  • Release of Pathologic Materials, if applicable;
  • Institutional Biosafety Committee (IBC) Approval, if applicable;
• Submits the applicable documents to the WIRB Liaison in the OIRB electronically to wirb@uab.edu with original UAB required documents delivered to the OIRB the same day (http://main.uab.edu/show.asp?durki=118397 [GUI340]).

OIRB Responsibilities

Administrative/Clerical Staff:

• Completes UAB/WIRB Initial Submission Review Checklist and attaches to protocol folder;
• Checks the submitted consent form to confirm that all required elements of FOR232 the UAB/WIRB Consent Form Template are included;
• Enters data regarding protocol into IRB database;
• Sends communication to CIRB requesting memo to include in submission;

The (designated) Senior Staff (WIRB Liaison):

• Confirms that the statement of conflict or no conflict form CIRB matches the investigator WIRB Initial Review Submission Form;
• Verifies compensation for injury language in consent is congruent with clinical trials agreement language.
• Verifies as complete, signs and dates on the bottom of the New Review Cover Letter/Checklist;
• Scans original forms that are UAB requirements into electronic and files originals in paper protocol folder;
• Forwards submissions to WIRB electronically.
• Forwards WIRBnet Online Submission Acknowledgement of Receipt with attached copy of signed New Review Cover Letter/Checklist to the investigator and/or contact;
• Makes label for WIRB protocol folder and places in “Pending” file drawer until WIRB approves then files in WIRB designated file cabinets.

Approved on March 1, 2010, by:

Sheila Deters Moore, CIP
OIRB Director