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What's New Archived 2009

12/23/09

  • VA Medical Center Links updated -

  • Submission Process -

    • R & D Application Packet updated to December 2009 version

12/14/09

  • Revised Board 2 roster available from Meeting Information page, Boards.

12/09/09

11/23/09

  • Revised Board 2 roster available from Boards page.

11/09/09

  • Revised Board 3 roster available from Boards page.

10/23/09

  • IRB meeting schedule for 2010 available from Meeting Information page.
  • IRB executive committee meeting schedule available from Meeting Information page.

10/09/09

  • Revised Boards 1, 2, 3, 4, and 5 rosters available from Boards page.

09/30/09

  • Revised Board 3 roster available from Boards page.

09/28/09

  • New Research Project Application (version date 9/28/09):  minor correction to the form.  The question pertaining to an adequate number of research personnel to fulfill all necessary roles was moved into the row below to allow for adequate space. 

09/14/09

  • IRB Newsletters are available from the What's New page.

09/10/09

  • The following forms have been revised and are available on the Forms page.  The IRB will accept previous versions of these forms through October 14, 2009.
  • New Research Project Application (version date 9/01/09):
    • Added statement above the General Information Section on Page One that reads: “If this project has been reviewed previously by the OU-Norman IRB, please provide documentation of this review.”
    • Section I. General Information:  revised question regarding investigator’s time allocation to read: “Does this individual have sufficient time to conduct and complete the research?”
    • Added the following question: “Is there an adequate number of qualified research personnel to fulfill all necessary roles of the study?”
    • Section II. Project Information: revised first question to read: “Has this research project been reviewed previously by the OUHSC or the OU-Norman Campus IRB?”
    • Section VII. Study Sites: removed “Room Number” fields and added questions regarding non-OU sites requesting the OUHSC IRB to be the IRB of record. 
  • Application for Continuing Review or Final Closure Report (version date 9/01/09):
    • Section I. General Information:  revised question regarding investigator’s time allocation to read: “Does this individual have sufficient time to conduct and complete the research?”
    • Added the following question: “Is there an adequate number of qualified research personnel to fulfill all necessary roles of the study?”
    • Section IV. Study Enrollment / Question #4 regarding # of participants accrued: defined "accrued" as "individuals who signed a consent form or underwent study-related procedures."
  • Determination of Human Research Worksheet (version date 9/01/09):
    • Instructions: revised to state that completed worksheets should be submitted to the IRB office for an official determination by an IRB Chair or Vice Chair. 
    • Section 1.2:  added "coded" as #3 and a definition.
    • Questions Section:  added questions specific to what type of information investigators are receiving (i.e. identifiable, de-identified) and the way in which they plan to record that information.

09/09/09

08/26/09

  • VA Medical Center Links updated as follows -
    • Contact Information updated to most recent of July 2009

    • Helpful Link VA Research & Development updated to www.research.va.gov/default.cfm

    • Submission Process & Meeting Schedule -

      • R & D Application Packet updated to July 2009 version
      • R & D Meeting Dates CY 2008/09 updated to 2009/10 version
    • Center Memorandums -
      • CM 151-4 R & D Committee updated to June 19, 2008 version
      • CM 151-4 (Change 4) R & D Committee added with May 15, 2009 version
      • CM 151-4 (Change 5) R & D Committee Membership added with August 6, 2009 version
      • CM 151-7 Investigational Drug Research updated to May 1, 2009 version
      • CM 151-20 Credentialing updated to February 2, 2009 version
      • CM 151-23 HRPP Program updated to April 15, 2007 version
      • R & D Standard Operating Procedures updated to June 3, 2009 version
      • Center Memorandums Log link remove

08/19/09

  • Revised VA Consent Template available from the Forms page. 
    • How Long Will I Be in the Study:  You fail to follow study requirements was added to the bulleted section; Risks of Genetic Testing:  the GINA language was modified; the VA header was removed from pages 2 and up; Norplant was removed from the Reproductive Risks section; the signature of the Principal Investigator was removed from the signature section.

08/12/09

  • Schusterman IRB room number changed to 4301 from Contacts page.

08/04/09

  • IRB Registration effective date and expiration date are available from The Federalwide Assurance page.

07/27/09

  • Revised Board 2 roster available from Meeting Information/Boards page.

07/07/09

  • Revised Consent Template available from the Forms page.  
    • How Long Will I Be in the Study:  You fail to follow study requirements was added to the bulleted section; Risks of Genetic Testing:  The GINA language was modified.

07/06/09

  • Information and a link concerning the new IRB Registration Requirement by the FDA is available from The Federalwide Assurance page.
    • In accordance with the OUHSC FWA, the OUHSC IRBs are already registered.  Click the FWA link from The Federalwide Assurance page for the individual IRB registration numbers.  The individual IRB registration numbers are also located on the top of each IRB membership roster.
  • 07/14/09 Education program handouts available from Education page.

06/01/09

  • 06/09/09 Education program handouts available from Education page.

05/19/09

  • Revised VA 10-1086 Consent form available from the Forms page.  
    • This version replaces the 05/18/09 version and incorporates some administrative changes such as the participant's initials on each page has been removed and a one inch margin has been added at the bottom of each page for the IRB stamp.

05/18/09

  • Revised Board 2 roster available from Boards page.
  • Revised Consent Template available from the Forms page.  
    • Risks: An optional cumulative radiation risk statement was added.  Reproductive Risks: Instructions were added to insert the sponsor's recommended birth control abstention time; require access to your medical records was changed to request access to your medical records. Risks of Genetic Testing: A new section was added concerning the Genetic Information Nondiscrimination Act (GINA).  Signature Section: Additional instructions were added.
  • Revised VA 10-1086 Consent form available from the Forms page.  
    • Risks: An optional cumulative radiation risk statement was added.  Reproductive Risks: Instructions were added to insert the sponsor's recommended birth control abstention time; require access to your medical records was changed to request access to your medical records. Risks of Genetic Testing: A new section was added concerning the Genetic Information Nondiscrimination Act (GINA).  Rights: VA telephone number changed.

04/24/09

  • IRB Mailing List available from IRB Home page.  Sign up available to join the IRB Mailing List.

04/22/09

  • Brown bag education series available from Education page.

03/30/09

  • Revised Board 4 roster available from Boards page.

03/13/09

  • Revised version of Protocol Deviation Report form available from Forms page.  On page 3, in the heading Corrective Actions Regarding the Unanticipated Problem, Roman Numeral IV was corrected to VI.

03/10/09

  • Revised version of Unanticipated Problems form available from Forms page. In Section III, the following questions were added: If the event is expected and related, is information regarding this risk included in the consent form?  If no, submit a Protocol Modification Form and a revised consent to the IRB to include this risk.

03/09/09

  • Revised Board 2 roster available from Boards page.

03/05/09

  • Revised Application for New Research Project from Forms page.  Revisions include minor administrative changes.  In Section I, clarified Investigator-Initiated Project and education requirement question.  In Section V, rearranged the order of the consent sections.

03/04/09

  • Revised Application for New Research Project from Forms page.  In Section VIII, the following questions were added: Does the protocol involve the use of ionizing radiation?  Are the number and frequency of these procedures the same for participants in this research protocol and non-participants with this condition or disease?
  • Revised SOP 602I available from Policies and Procedures page.

02/16/09

  • Revised Boards 1, 2, 3, 4, and 5 rosters available from Boards page

02/06/09

  • Revised Board 2 roster available from Boards page.
  • IRB Contacts updated.

 

 

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Library Building, Room 176
Phone: 405/271-2045 - Fax: 405/271-1677
IRB@ouhsc.edu

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