Procedure for Initial Review Using the Expedited Procedure - IRB PRO120

Abstract:
This procedure lists responsibilities of the investigator, OIRB and IRB for carrying out the initial review using the expedited procedure.
Effective Date:
2/4/2010
Responsible Party:
Contacts:
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
Subject:  Procedure for Initial Review Using the Expedited Procedure

PROCEDURE

Investigator Responsibilities

The investigator submits one copy of the following materials to the OIRB:

  • 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 Grants and Contracts Administration (OGCA) Tracking 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.
  • Waiver of 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;
  • Copies and mails approval form;
  • Files approval form and other correspondence in protocol file.

Administrative Staff:

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

Senior 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;
  • Documents if investigator identifies conflict of interest on application;
  • Obtains confirmation from the Conflict of Interest Review Board;
  • 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 senior staff;
    • Comments made by senior 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 senior staff;
  • Refers protocolz with identified conflict of interest for convened IRB review;
  • Uses the GUI329 Criteria for Approval Tool to determine whether the research meets the criteria at 45 CFR 46.111, and Subpart D if applicable, and 21 CFR 56.111 if applicable, and 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 senior staff to review approval status;
  • Refers the research protocols that cannot be approved by staff to shcedule for convened IRB review.

IRB Chair:

  • 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 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 senior staff to obtain additional information about any expedited protocoln on the list of approved protocols presented once month.

Approved on March 1, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director