Helpful Links

• 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.

05/23/08

• Revised Institutional Risk Assessment form available from Forms page and Institutional Risk Assessment page.
• Revised Boards 1, 2, 3, 4, and 5 rosters available from Boards page

05/12/08

• Revised Board 2 roster available from Boards page

04/30/08

• FWA updated.  New expiration date is 04/30/11.

04/22/08

• Spanish translated version of Research Privacy Form 1 available from Forms page
• Revised Board 2 roster available from Boards page

04/21/08

• Revised Board 4 roster available from Boards page

04/11/08

• Revised Board 2 roster available from Boards page
• Revised Consent Template and VA 10-1086 Consent form available from the Forms page.  Risk section was updated to remove reference to Norplant.

03/17/08

• Added Institutional Risk Assessment Form to Forms page. 
• Added Institutional Risk Assessment Procedure to IRB Processes and IRB Submission pages.

03/07/08

• Revised Board 2 roster available from Boards page

03/04/08

• IRB Contacts updated

02/23/08

• FAQ updated

02/11/08

• Revised Protocol Modification form available from Forms page.   Highlighted changes will no longer be accepted.  Track changes must be used.

02/08/08

• IRB Contacts updated

11/27/07

• Revised Consent Template and VA 10-1086 Consent form available from the Forms page

10/26/07

• Revised zip code available from Contacts page

10/25/07

• Revised New Project Application available from the Forms page

10/22/07

• Revised Continuing Review form available on Forms page.
  (Note: The Continuing Review form will now act also as the Final Closure Report form.)

10/19/07

• Revised rosters for Boards 1 (11/05) , 2 (10/22), 3 (11/19), and 4 (10/29) available from Boards page
• Updated application for Human Cell Lines and Derived Products

10/16/07

• Revised Board 4 roster available from Boards page

10/12/07

• Revised Board 3 roster available from Boards page

10/08/07

• Revised Board 2 roster available from Boards page

10/01/07

• Revised Board 1 roster available from Boards page

9/24/07

• Revised Board 2 and Board 4 rosters available from Boards page

9/21/07

• Added 2008 Meeting Dates and Submission Deadlines to the Meeting Information page

9/19/07

• AAHRPP awards OUHSC Human Research Protection Program full accreditation.  Click press release and benefits of accreditation.

9/10/07

• Revised Board 1 roster available from Boards page

8/30/07

• Added Course and Dates 2008 to Education page

7/23/07

• Revised Consent Template on Forms page
• Revised VA Form 10-1086 Consent Template on Forms page

7/13/07

• Invitation to Participants added to Participant Outreach page

6/21/07

• Added notice on Forms page that previous versions of forms will be accepted until July 16, 2007, and that on and after that date only revised versions of the forms should be used

6/19/07

• Added link to Training Materials Covering Revised Policies, Procedures, Forms, and Templates to the Policies & Procedures page

6/15/07

• We have revised many of our policies and procedures, IRB forms, and templates.  In order to provide you with detailed information regarding these revisions, review sessions will be available on the dates indicated below. 

   

  Please join us for one of the review sessions indicated below by contacting Deidre or Mary at 271-2045.

   

  Review sessions will be located in LIB 176 (OKC Campus) and in 1G13 (Tulsa Campus)

    

  Date	Time
  Tuesday, June 19	12:00 – 1:00
  Wednesday, June 20	10:30 – 11:30
  Thursday, June 21	2:00 – 3:00
  Tuesday, June 26	12:00 – 1:00
  Wednesday, June 27	10:30 – 11:30
  Thursday, June 28	2:00 – 3:00
  Tuesday, July 10	12:00-1:00
  Wednesday, July 11	2:00-3:00

• Revised searchable PDF HRPP/IRB Standard Operating Procedures available on Policies & Procedures page
• Revised Policies & Procedures links
• Revised Forms page links

6/13/07

• Board 1 Deadline for the July 2, 2007, meeting has been corrected to June 20, 2007
• Board 1 Deadline for the August 6, 2007, meeting has been corrected to July 25, 2007

5/24/07

• Added link to HRPP Organizational Chart on Contacts page
• Added Outside Contacts to Contacts page

5/2/07

• Added Institutional Risk Assessment page to navigation menu
• Added Institutional Risk Assessment Procedure and Form to Institutional Risk Assessment page

4/30/07

• Revised Board 4 roster available from Boards page

4/9/07

• Revised New Study Application and Continuing Review forms available from Forms page

3/12/07

• Revised rosters Board 1 and Board 2 available from Boards page

2/21/07

• Revised version of Unanticipated Problems form available from Forms page

2/16/07

• IRB Board 3 Roster updated

2/14/07

• Updated Investigator Manual to link to Policies and Procedures 2/1/2007

2/10/07

• Removed from What's New page, 01/25/06 announcement concerning IRB Policy 307 (IRB Fees).

2/1/2007

• Revised Policies and Procedures Effective 2/1/2007 are available from the Policies & Procedures page.

1/23/2007

• The AAHRPP accreditation site visit has been scheduled for 4/10-4/13/2007. Site visitors may request interviews with investigators.

• Information concerning new OHRP Guidance:

  "On January 18, 2007 OHRP posted on its website OHRP’s formal “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events” (dated January 15, 2007). The guidance can be found by going to the Policy Guidance [by topics] page on the OHRP website at http://www.hhs.gov/ohrp/policy/index.html, and clicking on either “Adverse Events” or “Unanticipated Problems” from the list of guidance topics. "

  An alternate link to the information described above is http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm

1/17/2007

• Posted SOP and Form Revision training dates on Policies & Procedures page

Training sessions covering these changes will be offered --

Friday, January 19th, from 2:00 to 3:00 at HSC in LIB 176, Schusterman 2D34
Tuesday, January 23rd, from Noon to 1:00 at HSC in LIB 176, Schusterman 2D34
Wednesday, January 24th, from 10:30 to 11:30 at HSC in LIB 176, Schusterman 2D34
Thursday, January 25th, from 2:00 to 3:00 at HSC in LIB 176, Schusterman 2D34
Tuesday, January 30th, from Noon to 1:00 at HSC in LIB 176, Schusterman 2C33
Wednesday, January 31st, from 10:30 to 11:30 at HSC in LIB 176, Schusterman 2D34
Thursday, February 1st, from 2:00 to 3:00 at HSC in LIB 176, Schusterman 2D34

1/16/2007

• Revised version of Consent Template posted on Forms page
• New Unanticipated Problem Report form available from Forms page
• Determination of Human Research Worksheet added to Forms page

1/13/07

• Revised version of New Study Application posted on Forms page
• Revised version of Continuing Review Application posted on Forms page

1/12/07

• PowerPoint show illustrating SOP and Form Revisions

11/16/06

• Protocol Outline updated

11/13/06

• IRB Board 1, 2, 3, 4, and 5 Rosters updated

11/04/06

• Updated VA links on VA page
• Updated affiliates on Federalwide Assurance page
• Updated FWA link on Federalwide Assurance page

10/25/06

• Revised OUHSC HRPP website's main navigation pages as follows
  • Forms now contains both IRB forms and HIPAA forms
  • IRB Processes now also includes links to Compliance Requirements and Special IRB Issues (now called Special Protection)
  • Meeting Information contains Meeting Schedules & Deadlines and Boards and Board Members
  • VA Links contains helpful links to VA information

10/19/06

• Updated HRPP home page to include a suggestion box

10/18/06

• Updated Contacts page

10/10/06

• Updated Contacts page
• Added link to VA Pamphlet "I'm a Veteran.  Should I Participate in Research" on Participant Outreach page

10/9/06

• 2007 Board Meeting Schedules
• Updated expiration date on Federalwide Assurance page
• Updated affiliates on Federalwide Assurance page

10/6/06

• IRB Contacts Updated
• Revised Contact Information on Participant Outreach page
• Added link to OHRP Pamphlet "Becoming A Research Volunteer: It's Your Decision" on Participant Outreach page

10/4/06

• Updated List of Attachments to include links to referenced documents

9/30/06

• Updated Forms page to include education information

9/15/06

• 2006 Board 2 Meeting Schedule Updated
• IRB Contacts Updated

9/7/06

• IRB Board 2 Roster Updated
• IRB Contacts Updated

8/16/06

• Added link to ORD Cyber Security Memo on VA Center Memorandums page
• Added link to Information Security Memo: Contacts to Veterans Involved in Research Projects on VA Center Memorandums page
• Updated Word and .PDF versions of Continuing Review form on Forms page

8/11/06

• Updated CITI Refresher training log in instructions from Education in Human Research page
• Updated New Study Application from Forms page
• Updated Additional Sub-Investigator Form from Forms page

8/7/06

• IRB Board 1 Roster Updated
• IRB Board 2 Roster Updated

8/4/06

• IRB Contacts Updated
• Revised Education in Human Research, Courses and Dates

7/21/06

• IRB Contacts Updated

7/20/06

• Updated link to OU Cancer Center from IRB Submission Process Discussion page

6/30/06

• Added updated version of Consent Template to IRB Forms Page
• IRB Board 1 Roster Updated
• IRB Board 3 Roster Updated
• IRB Board 4 Roster Updated

6/29/06

• Added OU Investigator Manual to IRB Processes Page

6/26/06

• IRB Board 2 Roster Updated

6/21/06

• Added linked information for the VA Medical Center (Helpful Links)

6/19/06

• IRB Board 3 Roster Updated

6/5/06

• Corrected Local Adverse Event - PDF version on IRB Forms page to include a "Possibly" checkbox in Item D1

5/30/06

• Added Institutional Commitment to the Protection of Human Research Participants statement to OUHSC homepage
• Added new Continuing Review in Word format to the IRB forms page
• Added new Continuing Review in .pdf format to the IRB forms page

5/28/06

• Updated Policies and Procedures page

5/25/06

• Added updated Local Adverse Event Report in MS Word format to IRB Forms page

5/22/06

• Added Sample Consent for Emergency Use Template to IRB Forms page
• IRB Board 3 Roster Updated
• Revised IRB Form - Local Adverse Event Report

5/17/06

• Added IRB Process Flowchart to the IRB Processes page.

4/27/06

• IRB Board 1 Roster Updated
• IRB Board 2 Roster Updated
• IRB Board 5 Roster Updated
• IRB Board 2 dated 1/9/2006 corrected
• IRB Board 2 dated 2/6/2006 corrected
• IRB Board 5 dated 1/9/2006 corrected

04/21/06

• Revised Patient Information Sheet, Tissue Banking (IRB number removed from header).

04/07/06

• IRB Administrative Support (Whom to Contact for Assistance) updated.
• Revised CITI Refresher Information (Education in Human Research).
• Corrected instructions on Continuing Review and Local Adverse Event (IRB Forms).

04/03/06

• IRB Board 1 Roster Updated
• IRB Board 3 Roster Updated, effective 04/17/06

03/29/06

• Consent Form Addendum.
• Consent Form Template - Updated Version to Use.
• Child Assent Form Template.
• IRB Policy 701 (Consent Process and Documentation), Section 1.8 includes policy on re-consenting participants.

03/17/06

• Added streamlined link - CITI Refresher Information (Education in Human Research). CITI Refresher Information also links to updated, in-depth instructions for CITI registration.

03/16/06

• Revised IRB Form - IRB Application for Continuing Review, section e.

02/28/06

• Redirected Cancer Related Studies (Submission Process) link.

02/20/06

• Revised IRB Form - IRB Application for Continuing Review.
• Updated SRC link (IRB Forms).
• Updated Research Involving Human Participants Required Education and Attestation (Education in Human Research).
• Revised CITI Registration document (Education in Human Research).
• Updated IRB Administrative Support (Whom to Contact for Assistance).
• Removed outmoded Email Recruitment option from IRB Submission Process Checklist (Submission Process).
• Removed IRB Meeting Schedules & Deadlines for 2005.
• Edited Affiliate List (Federalwide Assurance).
• Added the OUHSC FWA number to FAQs.

02/06/06

• IRB Board 2 Roster Updated

01/24/06

• Education in Human Research (Continuing Education) Updated
• Board 2 Meeting Schedule for February Updated

01/17/06

• IRB Policy 102C (IRB & HRPP Staff Education/Training)

01/09/06

• IRB Board 2 & Board 5 Rosters Updated

12/19/05

• IRB Board 1 Roster Updated

11/28/05

• The Board 2 meeting scheduled for December 19, 2005 has been cancelled due to lack of quorum.

11/19/05

• Submission Process Updated - Link to Human Biological Specimens Guidance
• IRB Board 1, 3, 4 Rosters Updated
• IRB Board 5 Roster Added

11/18/05

• Revised IRB Form - Human Cell Lines and Derived Products
• IRB Contacts Updated
• Submission Process Updated - Link to SRC Policy Regarding Tissue Studies

10/17/05

• Revised IRB Form - Human Cell Lines and Derived Products
• Revised HIPAA Form - Research Privacy Form 4 PHI Research Authorization

10/14/05

• 2006 Board Meeting Schedules

09/15/05

• New IRB Form - Human Cell Lines and Derived Products

09/02/05

• IRB Policy (Consent Documentation) 701, Section 1.3.B.1: The requirement for a certified/notarized attestation by a translator has been revised to just a written attestation from the translator.
• Clarification added on the use of the short form.

08/30/05

• Federalwide Assurance Affiliate List Updated

08/29/05

• IRB Board 4 Roster Updated

08/11/05

• Consent Form Template - Signature section revised.
• Consent for Non-English Speaking Subjects

07/28/05

• IRB Application (pdf) has been updated to reflect HRPP requirement questions for PI, Co-PI, Sub-I's and Coordinators.  Please download the most recent version of this document (07/28/2005) for use.  Also note that any person listed on a New Application (protocol modification or continuing review) must have completed HRPP requirements as outlined in Education in Human Research.  Submitted documents will be returned until HRPP requirements are satisfied or personnel are removed from the document (and the conduct of the study).

06/30/05

• Forms for reporting Protocol Deviations and Unanticipated Changes

06/24/05

• New IRB Policies & Procedures (effective 7/1/05)

06/14/05

• Adverse Event submission instructions revised

05/31/05

• IRB Board 1, 2, & 3 Rosters Updated
• HIPAA Research Privacy Forms (1-10) - removal of extra version date

05/19/05

• Be prepared!!  Updated information related to purchasing an Adobe license can be found on the IRB Forms page.  Please note:  In the very near future, all IRB forms will be converted to Adobe .pdf format.  It will be necessary for you to acquire your Adobe license so that you will be able to utilize the .pdf forms.  Word versions will be outdated and no longer accepted.  This conversion will take place over the summer months of 2005.  Get your license today!
• If you have downloaded the .pdf or Word version of the IRB Application for New Research to your hard drive, be advised that you may not have the most recent version.  The latest versions are dated 5/2005.  Please check your saved version and update your hard drive if needed.  If you submit an outdated version of the IRB application, it may be returned to you.  Save yourself some time by checking (NOW) to make sure you have the latest version of the IRB Application.

05/02/05

• IRB Board 1 Roster Updated

02/28/05

• All 4 IRB Board Rosters Updated

02/18/05

• Consent Form Template - New Version To Use
• Consent Form Template - New Version With Yellow Highlights for Change Reference

02/16/05

• Quality Improvement Program
• Federalwide Assurance
• Participant Outreach Program
• Frequently Asked Questions

02/14/05

• IRB Contacts Updated

01/06/05

• HIPAA Research Privacy Forms (1-4)
  Removal of Privacy Office email address

01/03/05

• Submission Deadlines and Number of Copies