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  • Food and Drug Administration FDA
  • Office for Human Research Protections OHRP

What's New on the Human Research Participant Protection Web Site

Note: If no link is provided on items below, then the information can be accessed directly from the frame on the left of the screen.

IRB Newsletters

What's New:

03/27/14

  • Revised Board 1, Board 2, Board 3, and Board 4 rosters available from Meeting Information page, Boards, effective 03/27/14.

 

02/27/14

  • Revised Board 1, Board 2, Board 3, and Board 4 rosters available from Meeting Information page, Boards, effective 02/27/14.

 

 

02/19/14

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 02/24/14.

02/11/14

  • VA Medical Center Links updated -

    • VA Handbook 1058.01 updated to November 15, 2011 version, available from VA Links.
    • VA Handbook 1108.04 updated to February 29, 2012 version, available from VA Links.

12/04/13

  • Revised Board 1, Board 2, and Board 4 rosters available from Meeting Information page, Boards, effective 12/04/13.

 

10/31/13

  • Revised Board 3 roster available from Meeting Information page, Boards, effective 10/31/13.

10/24/13

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 10/24/13.

10/17/13

  • Revised Board 4 roster available from Meeting Information page, Boards, effective 10/17/13.

09/20/13

  • Revised Board 3 roster available from Meeting Information page, Boards, effective 09/20/13.

09/13/13

  • Revised Board 5 roster available from Meeting Information page, Boards, effective 09/13/13.

07/18/13

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 07/18/13.

06/12/13

  • Revised Board 1 roster available from Meeting Information page, Boards, effective 06/12/13.

04/18/13

  • VA Medical Center Links updated:
    • Posted new version of VA Handbook 1200.05 dated 5/02/2012 - replaces version 10/15/2010

02/04/13

  • Revised Board 1 roster available from Meeting Information page, Boards, effective 02/04/13.

01/25/13

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 01/28/13.

01/02/13

  • Revised Board 3 roster available from Meeting Information page, Boards, effective 01/14/13.

11/28/12

  • IRB meeting schedule for 2013 available from Meeting Information page.

  • IRB executive committee meeting schedule for 2013 available from Meeting Information page.

11/27/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 11/26/12.

10/22/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 10/22/12.

09/24/12

  • Revised Board 4 roster available from Meeting Information page, Boards, effective 09/24/12.

09/17/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 09/17/12.

09/11/12

  • Revised Board 1 roster available from Meeting Information page, Boards, effective 09/10/12.

08/30/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 09/01/12.

07/19/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 07/23/12.

07/16/12

  • Revised Board 3 roster available from Meeting Information page, Boards, effective 07/16/12.
  • VA Medical Center Links updated -

    • Submission Process - R & D Application Packet updated to July 2012 version, available from VA Links.
  • IRB Contacts updated.

06/26/12

  • Revised Board 1 roster available from Meeting Information page, Boards, effective 07/02/12.

06/22/12

  • iRIS - Integrated Research Information System is now available for new study submissions from the iRIS page.
  • Log into iRIS at:  https://iris.ouhsc.edu
  • Register for iRIS training
  • IRB Submission Process updated with iRIS information.

06/15/12

05/03/12

  • Revised Board 1 roster available from Meeting Information page, Boards, effective 05/07/12.

04/30/12

  • Revised Board 4 roster available from Meeting Information page, Boards, effective 04/30/12.

04/16/12

  • Revised Board 3 roster available from Meeting Information page, Boards, effective 04/16/12.

04/05/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 04/09/12.

03/22/12

  • New Spanish version of the HIPAA Research Privacy Form 4 is now available from Forms page, Research Privacy Forms.

03/21/12

  • New Spanish version of the HIPAA Research Privacy Form 3 is now available from Forms page, Research Privacy Forms.
  • The expiration date for all OUHSC IRBs registered with DHHS has been updated to 03/21/2015. Information is available from the Federalwide Assurance page.  

03/15/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 03/15/12.
  • Revised Board 3 roster available from Meeting Information page, Boards, effective 03/15/12.

03/15/12

  • Spanish version of the HIPAA Research Privacy Form 1 has been updated (see summary of revisions from 01/03/12 below).
  • Submission of the revised version will only be required for new research projects and continuing review applications. 
  • New Spanish version of the HIPAA Research Privacy Form 2 is now available from Forms page, Research Privacy Forms.

03/05/12

  • Revised Consent Template effective 03/05/12:  Summary of Additions:  In the What About Confidentiality section, the following paragraph was added:  If this is an FDA regulated clinical trial:  A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  However, this website will not include information that can identify you.  At most, the website will include a summary of the study and results.  You can search this website at any time.  In the What if I am Injured or Become Ill section, the following guidance was added:  Wording that states or implies that the patient’s insurance, Medicare or Medicaid will be billed first before sponsor will pay is NOT allowed.)

02/28/12

  • Revised Board 5 roster available from Meeting Information page, Boards, effective 02/28/12.

02/01/12

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 02/01/12.

01/30/12

  • Revised Board 4 roster available from Meeting Information page, Boards, effective 01/30/12.

01/20/12

  • Revised IRB meeting schedule for 2012 available from Meeting Information page.  Board 2 deadline for October 8, 2012 meeting corrected from September 15, 2012 to September 25, 2012.
  • IRB Contacts updated.

01/10/12

  • VA Medical Center Links updated -

    • Submission Process - R & D Application Packet updated to May 2011 version, available from VA Links.
  • Revised Board 3 roster available from Meeting Information page, Boards, effective 12/19/11.

01/05/12

  • HIPAA Research Privacy Forms 1, 2, 3, and 4 revised (version date: 01/04/12). 
  • Submission of the revised versions will only be required for new research projects and continuing review applications. 
  • Summary of Revisions:   Changed subject to participant and Protected Health Information to PHI.  The contact information for the Privacy Board was added to the End of Permission section. Revoking Permission was changed to Cancelling Permission.  The bolded section concerning communicable diseases was added to forms 2, 3, and 4.  A new section “Access to Information” was added to forms 1 – 4.  The check boxes were removed from forms 3 and 4.

01/03/12

  • HIPAA Research Privacy Forms 5-10 revised (version date: 12/19/11). 
  • Submission of the revised versions will only be required for new research projects and continuing review applications. 
  • Summary of Revisions:  Language was added to forms 5 – 10 such as a certification section above the PI’s signature area on form 5.  Language has been added to the PI’s representation section on forms 6, 7, 8, and 9. On form 10, the 2nd paragraph was added.  Also on form 10, sections 8, 9, 10, and 11 were added.

12/14/11

  • IRB Contacts updated.

11/23/11

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 11/28/11.

11/10/11

  • IRB meeting schedule for 2012 available from Meeting Information page, Meeting Dates & Submission Deadlines, All Boards.
  • IRB Executive Committee meeting schedule for 2012 available from Meeting Information page.

09/12/11

  • Revised Board 1 roster available from Meeting Information page, Boards, effective 09/12/11.

08/11/11

  • The OU Health Sciences Center Federalwide Assurance (FWA) has been updated and the new expiration date is 08/08/2016.  The expiration date for all OUHSC IRBs has been updated to 02/16/2014.  The information is available from The Federalwide Assurance page. 

08/08/11

  • Revised Board 2 roster available from Meeting Information page, Boards, effective 08/08/11.
  • Revised VA Consent Template available from the Forms and VA Links page.  The witness or Investigator signature is not required on the VA Consent Form unless requested by the IRB or sponsor.
  • New VAMC Authorization for Release of Protected Health Information for Research available from the Forms and VA Links page. 

07/05/11

  • Revised Board 1 rosters available from Meeting Information page, Boards, effective 04/04/11 and 06/06/11.

07/01/11

  • IRB Contacts updated.

03/04/11

  • The FDA is amending the current informed consent regulations to require that informed consent documents for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank.  The complete announcement is in the Federal Register at the following link:  Federal Register: Informed Consent Elements.  The IRB will be updating the consent template to include the new statement.

02/23/11

  • Revised SOP 602-G effective 02/15/11 is available from the Policies & Procedures pageDefinitions were added for Medical, Clinical, and FDA regulated research for clarification in Sec. 1.1.1.  Paragraphs 5 and 6 were added to Sec. 1.1.2.  Section 1.1.3 was added.

02/11/11

  • Revised Board 3 roster available from Meeting Information page, Boards, effective 02/21/11 .

01/24/11

  • Revised Board 5 roster available from Meeting Information page, Boards, effective 01/24/11.

01/21/11

  • Revised Board 1 roster available from Meeting Information page, Boards, effective 02/07/11.
  • Revised Board 2 roster available from Meeting Information page, Boards, effective 01/24/11.

01/11/11

  • Revised Board 4 roster available from Meeting Information page, Boards, effective 01/31/11.

01/10/11

  • Revised Board 2 roster available from Meeting Information page, Boards.
  • Revised Board 3 roster available from Meeting Information page, Boards, effective 01/17/11 .
  • IRB In-House Education Cancellation:

    • Due to the potential for inclement weather in Oklahoma City and Tulsa, the IRB In-House Education Program scheduled for January 11, 2011 has been cancelled.  Efforts are underway to reschedule the program sometime in February or early March.  Personnel scheduled to attend will be informed when that date has been confirmed.  We apologize for any inconvenience.  This is not a campus delay or closure notice!

12/13/10

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

11/30/10

  • VA Medical Center Links updated -

  • Submission Process -
    • R & D Application Packet updated to February 2010 version including delegation of authority change

11/22/10

  • VA Medical Center Links updated -

  • VA Research Handbooks-

    1058.01 Research Compliance Reporting Requirement

  • VA R&D Meeting Dates CY 2011/12 available

11/16/10

  • Updated IRB meeting schedule for 2010.  Board 1, December 13 meeting has been changed to December 6.

11/11/10

  • VA Medical Center Links updated -

  • VA Research Handbooks-
    • 1200.5 VA Handbook of Requirements for Protection of Subjects in Research updated to October 15, 2010 version
  • IRB Contacts updated.

10/18/10

  • Revised Board 1 roster available from Meeting Information page, Boards.
  • Revised Board 4 roster available from Meeting Information page, Boards.
  • IRB meeting schedule for 2011 available from Meeting Information page, Meeting Dates & Submission Deadlines, All Boards.
  • IRB Executive Committee meeting schedule for 2011 available from Meeting Information page.

09/08/10

08/31/10

  • Brown Bag Sessions Registration Form now available on the Education Page.

08/19/10

  • IRB Contacts updated.

08/11/10

  • Revised Board 4 roster available from Meeting Information page, Boards.
  • IRB Contacts updated.

08/04/10

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

07/30/10

  • Revised Board 1 roster available from Meeting Information page, Boards.

07/28/10

  • IRB Contacts updated.

07/19/10

  • Corrected Board 3 roster available from Meeting Information page, Boards.

06/03/10

  • Board 2 meeting scheduled for June 28 has been cancelled.

05/17/10

  • VA Medical Center Links updated -

  • VA Research Handbooks-
    • 1200.1 R & D Committee added utilizing June 16, 2009 version
    • 1200.5 VA Handbook of Requirements for Protection of Subjects in Research updated to July 31, 2008 version
    • 1200.19 Presentation of Research updated to September 17, 2008 version

05/10/10

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

04/15/10

  • New Research Project Application (version date 2/22/2010): modified the form fields for consistent formatting (e.g. font type, font size, underline, bold)  The version date of the form will remain 2/22/2010.

02/25/10

02/22/10

  • New Research Project Application (version date 2/22/2010):  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. 

02/05/10

Revised Policies and Procedures effective 01/15/10 are available on the Policies & Procedures page. 

The following new form is available on the Forms page.

This form includes specific questions concerning Human Participant Research involving Department of Defense (DoD)

The following forms have been revised and are available on the Forms page.  The IRB will accept previous versions of these forms through March 5, 2010.

Added definition of experimental subject in Part 2, Determination of Human Research

Added two bullets to clarify Section III, Determination of Unanticipated Problem.

01/11/10

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

12/23/09

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.

 

What's New Archived

 

 

Institutional Review Board (IRB) - OU Health Sciences Center
Library Building, Room 176
Phone: 405/271-2045 - Fax: 405/271-1677
IRB@ouhsc.edu

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