Procedure for Continuing Review of Research by the Expedited Procedure - IRB PRO150

Abstract:
This procedure outlines the responsibilities of the investigator, OIRB and IRB for the continuing review of research by the expedited procedure.
Effective Date:
1/25/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO150
Effective Date:   3/30/07
Revision Date:  11/2/09, 1/25/10
Subject:  Procedure for Continuing Review of Research by the Expedited Procedure

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Endeavors to submit continuing review application materials at least 30 days prior to expiration date to avoid a lapse in the protocol.
  • Submits one copy of the following materials:
    • FOR200 Human Subjects Protocol (HSP) application updated with any changes.
    • Completed and signed original FOR225 Investigator’s Progress Report (IPR). If the research is complete (i.e., no subjects having interventions or follow-up, no data acquisition, management or analysis, all reports completed), mark IPR as final;
    • Memorandum from Principal Investigator confirming or revising the Children’s Risk Level (CRL), if applicable;
    • Current informed consent document(s)—not required if study is closed to enrollment;
    • Addendum informed consent document(s) for currently enrolled participants, if applicable
    • Revised informed consent document(s) with changes highlighted, if applicable;
    • A “clean” copy of the informed consent document(s) to receive IRB approval stamp;
    • Updated funding application, if applicable.
  • Ceases all research activities including stopping new enrollment, recruitment, advertisements, procedures on current participants, and collection of identifiable private information if the IRB has not reviewed and approved the research by the expiration date; makes a written request to the IRB for research activities to continue following expiration of IRB approval if there is an overriding safety concern or ethical issue present such that it is in the best interests of individual participants to continue participating in research interventions and interactions.

OIRB Responsibilities

Clerical Staff:

  • Documents receipt of application and retrieves file;
  • Copies and mails original approval form to principal investigator;
  • Files copy of approval form and other correspondence in protocol file.

Administrative Staff:

  • Sends a notice to investigators at least 2 months prior to expiration date of approval of protocol to submit continuing review application;
  • Sends a notice to investigators with protocol approvals scheduled to expire within 2 weeks containing the following information:
    • If the IRB has not reviewed and approved the protocol, all research activities must cease until formal approval of the protocol has been issued.
  • Enters protocol information into database;
  • Generates report to Conflict of Interest Review Board for review;
  • Checks investigators’ and research personnel's training status;
  • Generates expedited approval form for signature;
  • Forwards protocol file to senior staff;
  • Sends correspondence generated after expedited review to principal investigator.

Senior Staff:

  • Reviews submission to determine applicability and category of research satisfied for expedited review;
  • Forwards to IRB Chair (or designee) if research open for long-term survival only or for data analysis only;
  • Performs preliminary review on remaining applications and protocol file and documents criteria for expedited review is met on expedited worksheet;
  • Forwards applications and protocol file to Chair (or designee) after preliminary review;
  • Sends required correspondence to principal investigator;
  • Prepares a list of approved protocols and protocols referred to the convened IRB for review.

IRB Responsibilities

IRB Chair or designated experienced IRB reviewer:
  • Receives the following information, as applicable:
    • Investigator’s Progress Report;
    • Protocol amendments/revisions since the last review;
    • Informed consent document(s), if applicable;
    • Memorandum confirming the number and criteria of the Children’s Risk Level, if applicable;
    • Summaries of reportable problems (including adverse events) for determination as to unanticipated problems involving increased risks to subjects or others;
    • Preliminary research findings;
    • Manuscripts;
    • Abstracts;
    • DSMB or other monitoring reports;
    • Progress reports to and from sponsors.
  • Uses the Criteria for Approval Tool (GUI311) to determine whether reviews the research accordance with 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.
  • Verifies research meets applicability criteria and categories of research for expedited review;
  • Determines if criteria for approval are met according to 45 CFR 46.111 and 45 CFR 46 Subpart D if applicable, and 21 CFR 56.111 if applicable, and 21 CFR Subpart D if applicable;
  • Refers protocol to convened IRB if the research cannot be approved with or without modifications to secure approval;
  • Returns continuing review application with file to senior staff following review.

Approved on January 25, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director