Procedure for Initial Review Using the Expedited Procedure - IRB PRO120

Procedure for Initial Review Using the Expedited Procedure - IRB PRO120

This procedure lists responsibilities of the investigator, OIRB and IRB for carrying out the initial review using the expedited procedure.
Effective Date:
Responsible Party:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:


HRPP Document:     PRO120
Effective Date:   3/30/07
Revision Date:  11/2/09, 2/4/10, 11/7/14
Subject:  Procedure for Initial Review Using the Expedited Procedure



Investigator Responsibilities

An investigator submits one copy of the following information to the OIRB in sufficient detail to evaluate and make a determination that the protocol satisfies the approval criteria (see 45 CFR 46.111 and, if applicable, 21 CFR 56.111 and any other funding agency regulations, as applicable):

  • Completed FOR200 Human Subjects Protocol. Principal investigators who are students list the faculty advisor/course instructor’s name, signature, and e-mail address;
  • Application for funding (whether intramural or extramural); includes the Office of Sponsored Programs proposal number, if applicable;
  • Informed consent document(s), if applicable, to enroll subjects or collect biological specimens (If research is NIH-sponsored and being conducted by an OHRP-recognized Cooperative Protocol Research Program, include a copy of the NIH approved sample informed consent document);
  • The complete DHHS-approved protocol (when one exists);
  • Sponsor’s protocol, if applicable;
  • Investigator’s Brochure, if applicable;
  • Form FDA 1572, if applicable;
  • Special populations supplemental forms pertaining to vulnerable subjects (FOR220 pregnant women, fetuses, neonates; FOR222 children);
  • Includes additional information on prospective decisionally impaired participants as indicated in (PRO125), if applicable;
  • Verification of Notification of Proposed Research for protocol-related performance sites;
  • Documentation of IRB approval from other site(s) engaged in research, if applicable;
  • Documentation/verification of the sponsor’s injury compensation policy;
  • Sponsor billing form;
  • Notification from Clinical Trials Office for compliance billing language;
  • Memorandum documenting that the research satisfies Children’s Risk Level of 1, 45 CFR 46 Subpart D if applicable, and 21 CFR 56 Subpart D if applicable;
  • Questionnaires, surveys, or scripts to be used with participants, if any;
  • Release of Pathologic Materials for materials obtained from Department of Pathology (FOR215, FOR216), or a specimen release form or approval letter if the study involves obtaining pathological or diagnostic specimens from another department. The head of the department responsible for providing the specimens should sign the approval letter;
  • Release of Drugs for Human Research Use form signed by the appropriate pharmacy (FOR217 UAB or FOR218 Children’s Hospital) for all drugs used in the protocol;
  • FOR209 patient authorization, FOR211 request for waiver of patient authorization, or FOR212 request for partial waiver of patient authorization to solicit and/or use protected health information (PHI) (alteration of HIPAA authorization in whole or in part) form, as applicable;
  • Additional materials relevant to the research;
  • FOR205 Protocol Oversight Review Form or other departmental approvals, as applicable;
  • Advertisements or other recruitment materials, if applicable;
  • Special approvals, if applicable.

OIRB Responsibilities

Clerical Staff:

  • Documents receipt of application;
  • Sends, electronically, approval form and approved consent forms, if applicable;
  • Files approval form and other correspondence in protocol file.

Administrative Staff:

  • Enters protocol information into database;
  • Checks investigators’ and research personnel's training status;
  • Generates expedited approval form for signature;
  • Creates protocol file;
  • Forwards to review staff;
  • Sends signed approval form and stamped approved informed consent document, if applicable, to the principal investigator.

Review Staff:

  • Performs preliminary review to judge whether the research satisfies the criteria for expidited review procedure (see OHRP Categories eligible for expedited review);
  • Documents comments on GUI309 preliminary review worksheet and includes in the protocol file;
  • Reviews management plan if investigator identifies conflict of interest on application;
  • Prepares and forwards application with protocol file for IRB reviewer, including:
    • All application materials submitted by the investigator;
    • All written requests made to the principal investigator or contact by review staff;
    • Comments made by review staff;
    • Responses from principal investigator;
    • Approval form.
  • Prepares correspondence to be sent to Principal Investigator regarding IRB review and determinations from expedited review;
  • Forwards approvals to clerical staff for issuance and filing;
  • Schedules unapproved protocols referred for convened IRB review;
  • Prepares list of protocols approved through expedited review procedure for convened IRB confirmation;
  • Submits list of approved protocols using the expedited procedure with the materials to the convened Board once a month.

IRB Responsibilities

IRB Reviewer:

  • Receives and reviews the application with the prepared research protocol file and verifies that the research meets the requirements for review by expedited procedures (see OHRP Categories eligible for expedited review);
  • Verifies documentation of conflict of interest by review staff;
  • Refers protocols with identified conflict of interest for convened IRB review;
  • Uses the GUI329 (b) Criteria for Approval Tool to determine whether the research meets the criteria at 45 CFR 46.111, and Subpart D if applicable; 21 CFR 56.111 if applicable; 21 CFR 56 Subpart D if applicable; and the Procedure for Review of Decisionally Impaired Adults Involved in Human Subjects Research (PRO125), if applicable;
  • Approves the research study—or approves the research following modifications to receive approval—if the above criteria are satisfied and returns to review staff to review approval status;
  • Refers the research protocols that cannot be approved by the above procedure to senior staff to schedule for convened IRB review.

IRB Chair (or designee):

  • Reviews and signs approval form for expedited review.

Convened IRB:

  • Approves the list of protocols that received approval by the expedited procedure;
  • Reviews research approved by the expedited procedure for convened IRB review if requested to do so by any IRB member;
  • Reviews research referred by the IRB Chair (or designee) or experienced IRB reviewer and not approved by the expedited procedure (see PRO122 Procedure for Initial Review of Proposed Research at the Convened IRB Meetings);
  • Contacts the review staff to obtain additional information about any expedited protocol on the list of approved protocols presented once month.

Approved on December 10, 2014, by:

Ferdinand Urthaler, MD
IRB Chair

Jonathan Miller, MPPA, CIP
OIRB Director