What's New in the HRPP

What's New 2018:

 8/7/2018

NEW! Incident Report Form for HSC is live!

Investigators reporting protocol deviations, unanticipated problems, or other events to the HSC IRB must use the new HSC Incident Report Form in iRIS. 

The Protocol Deviation Report and Unanticipated Problem (UP) Report Forms are now labeled NC to indicate that they are to be submitted to the Norman Campus IRB only. 

Any events submited to the HSC IRB on the Protocol Deviation or UP Report Forms after 8/7/2018 will be withdrawn and investigators will be asked to complete the HSC Incident Report Form. 

 

 8/3/2018

OUHSC CAMPUS: NEW! Incident Report Form Coming Tuesday, Aug. 7, 2018:

The submission process for reporting Protocol Deviations and Unanticipated Problems (UP) to the is changing!
The OUHSC IRB Office is rolling out a combined form called the HSC Incident Report Form.

Investigators should use this form beginning Tuesday, August 7th, when reporting deviations and UPs to the HSC IRB.

iRIS users must be careful, though! The previous forms for Protocol Deviations and UPs will still be accessible in the list of submission forms. The Protocol Deviation and UP Report forms will be renamed to include ‘NC’ to indicate that they are now for the Norman Campus only.

Please note that the HSC IRB Office will not accept any Protocol Deviation Reports or UP Reports after August 7th. Events reported on these forms will be withdrawn and you will be asked to use the new HSC Incident Report Form.

Please contact the OUHSC IRB Office at IRB@ouhsc.edu or 405-271-2045 if you have any questions.
Thank you.
 

 7/16/2018

All iRIS summer training dates are full. Please check back on the iRIS page of the HRPP website at the beginning of August for a list of fall training dates. Thank you.

 

7/16/2018

New Board 3 roster have been published. You can find it here.

 

7/2/2018

New Board rosters have been published for all Boards. You can find them here.

 

6/26/2018

New OUHSC Consent Template, Effective June 26, 2018:

A new version of the OUHSC Consent Template has been published, effective June 26, 2018.  New template language for subject injury has been added for both industry-sponsored and non-industry sponsored research. Revisions may still be required to the subject injury language pending completion and execution of clinical trial agreements and contracts in ORA. 

The updated consent template can be accessed on the Forms & Templates page under Researcher's Toolkit and in the Help section of iRIS.

WHICH RESEARCH STUDIES NEED TO USE THE NEW CONSENT TEMPLATE?

  • New research studies submitted to the IRB on 6/27/2018 or later must use the new consent template version.
  • Ongoing studies that have already been approved by the IRB do not need to transition to the new form version; and
  • New studies that are pending final IRB approval do not need to transition to the new form version.
     

 

6/18/2018

Final Rule Issued to Delay the Revised Common Rule for an Additional 6 Months:

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are issuing a Final Rule to delay for an additional 6 months the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule).

This Final Rule delays the general compliance date for the 2018 Requirements (aka, Revised Common Rule) with a new effective date of January 21, 2019.  

The transition provision in the Final Rule is structured so that regulated entities cannot implement the revised Common Rule in its entirety, in lieu of compliance with the current version of the Common Rule, until the general compliance date of January 21, 2019.   As a result of this delay to the general compliance date, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Common Rule until January 21, 2019. The exception to this general rule is that institutions will be permitted (but not required) to implement, for certain studies, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018 through January 20, 2019). The three provisions are:

(1) The revised definition of “research,” which deems certain activities not to be research;

(2) The allowance for no annual continuing review of certain categories of research; and

(3) The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.
 

Stay tuned to our website as further updates from the HRPP Office will be posted here in the coming weeks.

 

06/13/2018

06/08/2018

  • A new version of the HSC IRB Application has been published in iRIS
    Users must convert to the new form when prompted in iRIS. If after converting you find yourself in Section 5000 - Exit Application Interview, go back to the top and click 'Save and Continue to Next Section' through all sections to ensure you have answered each question. You should not lose any information that was previously entered. 

 

05/23/2018

  • iRIS training opportunities are now available for this summer!
    RSVP for each session is required and space is limited for each session! Visit the iRIS page for more information, including a list of dates and times! Please contact the IRB office at 405-271-2045 if you have questions or would like to schedule a session for a different date/time. 
     

05/01/2018

IRB Education Requirements Announcement:    

The IRB In-House Program has been eliminated as a separate requirement. All future dates of the IRB Program have been cancelled and D2L is no longer available as an option. 
Local context information such as OUHSC-specific requirements and the Written Attestation have been incorporated into the CITI training, effective May 1, 2018.  Completion of the modules and quiz will serve as documentation of a signed and dated attestation.  These new modules will be included with all subsequent CITI courses completed for OUHSC (e.g. Refresher Courses, etc.). 

More information, including the Provost's Memo regarding IRB Education Requirements, can be found on the Education page. 
 

04/18/2018

IRB In-House Prorgram Announcement:    

The IRB In-House Program scheduled for April 24, 2018 has been cancelled. Individuals who were registered to attend the April program do not need to reschedule for the June program at this time. Alternative arrangements for the IRB Program will be distributed directly via email. In the meantime, those registered for the April IRB Program may continue with research activities as approved by the IRB as long as the CITI web-based course has been completed.

  • If you have not previously registered for - or attended - an IRB Program, please register for the June 26, 2018 IRB Program via the form on the Education page. 
  • Stay tuned to the website and your emails over the next several days for an important announcement regarding IRB Education and Training at OUHSC. 
     

Please contact the HRPP office at IRB@ouhsc.edu or 405-271-2045 if you have any questions or comments regarding this announcement. 
 

03/20/2018

02/28/2018

02/23/2018

01/17/2018

IRB In-House Program Announcement

Effective January 9, 2018, attending the IRB In-House Program in person will no longer be mandatory for residents, students, and fellows. As an alternative to this training, residents, students, and fellows can elect to complete a web-based version of the IRB In-House Program via D2L.

Completion of the D2L training is required prior to approval of research or modifications to add new key study personnel, which is the same for CITI training requirement. Residents, students, and fellows should email the HRPP office at IRB@ouhsc.edu to register for the D2L course.

Faculty and staff will continue to follow the current training requirements by attending the in-person IRB In-House Program.

Please contact the HRPP office at IRB@ouhsc.edu or 405-271-2045 if you have any questions or comments regarding these changes. 
 

01/19/2018

  • New Modification/Notification Form and HSC Application published in iRIS. Convert to the new form when prompted.
    • HSC APP NOTE: After you convert to the new version, please go to Section 1.0 of the form and click 'Save and Continue' through the entire form to ensure each question has been answered. 
    • You will not lose any previous work.
       

01/17/2018

Updated Information Regarding the Revised Common Rule:

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).  Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. 

The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

The IFR has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf .

 

01/12/2018

 

What's New 2017:

12/18/2017

Update: Revised Common Rule (45 CFR 46, Subpart A) - Important Dates

On January 18, 2017, the Department of Health and Human Services issued the final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The effective date for most provisions is January 19, 2018*. 
 

The University’s Human Research Participant Protection (HRPP) offices are developing a transition plan to implement these revised regulations.  To this end we want to alert you that the HRPP will need to take down iRIS for one week to upgrade the system to implement these regulatory changes.  Therefore, the current plan is to take iRIS down the week of January 15 – 21, then re-open on Monday, January 22, 2018.  Below is the planned timeline of events based on the implementation date:

  • January 3, 2018:  iRIS will be closed to new study submissions at 4:00pm. Continuing Reviews, Modifications, and other submissions will continue to be accepted.
  • January 4-14, 2018: Time needed for IRB to review new study submissions, get responses for stipulations, and grant final IRB approval. 
  • January 15, 2018: iRIS down for upgrade and testing.
  • January 22, 2018: iRIS up to accept all submissions. 
  • January 2018: Education sessions for research community (dates to be determined); update and publish guidance, new consent templates, and transition details. 

NOTE: The above schedule should allow enough time for the HRPP / IRB to complete its review of anything submitted prior to January 19th to remain under the “pre-2018 Rule.”  Research approved January 19, 2018 and beyond must meet the updated requirements of the “2018 Rule”, and is subject to the updated consent and exemption requirements. Any exceptions to the above schedule or urgent submissions will be considered for acceptance on a case-by-case basis.

 

12/1/2017

Revised Common Rule (45 CFR 46, Subpart A)

On January 18, 2017, the Department of Health and Human Services issued the final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The effective date for most provisions is January 19, 2018*. 
 
Summary of major changes effective January 19, 2018: 
  • Improvements to the informed consent process and documents.
  • Posting of consent documents to public website for applicable trials. (E.g. ClinicalTrials.gov website)
  • Continuing Review for some minimal risk research may no longer be required.
  • Clarification and addition of new categories of exempt research. 
 
Summary of major changes effective January 20, 2020
  • Single IRB of Record (sIRB) requirements for certain cooperative research. 
    [NOTE: the NIH sIRB Policy effective date is January 25, 2018.]

 

The revised Common Rule allows for other changes such as "broad consent", but will not be implemented at OUHSC at this time. 

 
Other resources for the revised Common Rule can be found at:

 

Please check the HRPP website regularly for updates.

*On October 7, 2017, HHS proposed a one-year delay of the implementation date of the revised Common Rule. The proposed delay is currently pending review. 

 

11/2/2017

  • New! 2018 IRB Meeting Schedule and Executive Committee Meeting schedules posted on the Meeting Schedule & IRB Rosters page in the 'About Us' section.

11/2/2017

10/27/2017

10/23/2017

  • The process for requesting and using an External IRB has been added to Researcher's Toolkit page. Please review this process and contact the HRPP Office before initiating any reliance agreements with an outside (central, external) IRB.  
  • Some of the menu options on the IRB website have changed
    • Resources page is now the Researcher's Toolkit
    • Policies & Procedures page is now back in the main (red) menu bar.
    • Announcements page is now News & Announcements
       

10/03/2017

Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality – Effective October 1, 2017
(See notice here – https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html)

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016, and collects or uses identifiable, sensitive information will automatically be issued a Certificate of Confidentiality (CoC) for applicable NIH awards as part of the award terms and conditions.
 

This policy applies to all biomedical, behavioral, clinical, or other research funded wholly or in part by the NIH.

NOTE: Studies that have a CoC must include specific language in the informed consent form (if applicable to the research study). The OUHSC IRBs will evaluate NIH-funded studies on a case-by-case basis and may request investigators revise their consent forms to add CoC language at the time of Continuing Review or Modification submissions (see OUHSC Consent Template for language).

Please visit the NIH CoC website for more information: https://humansubjects.nih.gov/coc/index  You can also visit their FAQs page for helpful information pertaining to CoCs.  Additional links and information are also posted the Researcher's Toolkit.
 

09/20/2017

  • New VA Consent Template, Form 10-1086, effective 9/2017 has been added to the Forms & Templates page. This is available on the Forms & Templates page in the Researcher's Toolkit.

09/18/2017

09/08/2017

09/01/2017

08/25/2017

07/24/2017

06/20/2017

  • Effective June 15, 2017, the CITI training requirement has been extended from 2 years to 3 years. The Provost Memo and updated training requirements are listed on the Education page. 

06/19/2017

  • Good Clinical Practice (GCP) Training for Social/Behavioral Research is now available in CITI through the University's subscription. This update has been added to the Education page. 

06/12/2017

  • Information regarding NIH's Good Clinical Practice (GCP) training has been added to the Education page. 

05/22/2017

05/17/2017

  • The July Board 1 meeting has been moved to July 10th. The agenda deadline for this meeting date is June 27. 

03/03/2017

02/07/2017

  • Major iRIS Update: iRIS will be OFFLINE during Spring Break (March 11-19)

iRIS will be unavailable to everyone on the HSC and Norman campuses from Saturday, 3/11/2017 through Sunday, 3/19/2017 for a system upgrade. 

This offline period will affect IRB Meetings for HSC. Please view the revised Board Meeting Schedule under About Us to see if your agenda deadlines or meeting dates have been changed.

We apologize for any inconvenience this may cause.

 

1/20/2017

1/20/2017

What's New 2016:

12/2/2016

Effective January 1, 2017, “all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).“

Note that GCP training for researchers conducting clinical studies is in addition to the University’s human participant protection training. If your funding agency requires GCP training, you must maintain documentation related to that training. The OUHSC HRPP does not monitor GCP training compliance.

GCP training is available through the University’s CITI Program subscription.  If you would like instructions on how to access the University’s CITI GCP training, please contact the OUHSC HRPP at 405-271-2045 or send an email to irb@ouhsc.edu.

 

11/2/2016

11/1/2016

10/17/2016

10/7/2016

  • A new application form 'Relying on an External IRB' is now available in iRIS for research studies that have been approved by the University for central IRB oversight.
    ONLY USE THIS FORM IF YOUR STUDY FALLS UNDER AN ESTABLISHED IRB AUTHORIZATION AGREEMENT WITH A NON-OU IRB.
    If you have questions, please contact the OUHSC HRPP Office at 405-271-2045 or the Norman Campus HRPP Office at 405-325-8110.
     

09/21/2016

09/20/2016

  • Menu options on the IRB website have changed! Please click on each link to see the new layout!
    Most notable changes include:
    • Policies & Procedures and Forms & Templates are now in the Researcher's Toolkit page/menu option
    • Meeting Information, FWA, and Contact Us pages are now under the new About Me page/menu option
    • A new Submission Process & Guidance page has been added to the Researcher's Toolkit page/menu option

09/09/2016

09/02/2016

  • Revised IRB Application, Continuing Review, Unanticipated Problem and Protocol Deviation Forms have been published. Please convert to the new versions of each form when prompted. 

08/05/2016

7/25/2016

5/11/2016

  • Revised rosters for Board 1, 2, 3, and 4 are available on the Meeting Information page, effective 05/11/2016. 

04/05/2016

 

02/10/2016

  • Revised rosters for Board 2 and Board 4 available from Meeting Information page, effective 02/01/2016.

     

01/06/2016

  • Revised Research Privacy Forms (HIPAA Forms) 1-10, version dated 01/06/2016
    • HIPAA Forms are available on the IRB website and iRIS
    • HIPAA Forms must be used for all Initial Submission Packets.
    • HIPAA Forms must be updated for all active studies at the time of continuing review.
    • Changes include: adding new language for clarification on all forms, removing IRB# text boxes, added headers to Forms 5-10, and rephrased the last paragraph regarding study contact so investigators do not have to enter the study title two times.

 

 

What's New 2015:


08/03/2015

  • Revised SOP 104A Conflict of Interest in Human Participant Research
    • Section 1.2 Individual Investigator COI Policy - revised thresholds from 5K to 10K to coincide with Board of Regents Policy and Faculty Handbook
    • Section 7 Process Overview - clarified how COI's will be submitted, reviewed, and monitored 
    • Section 3 Investigator Responsibilities - clarified the COI Disclosure Form is now a sub-form in the initial application


What's New 2014:

 

11/03/14

10/01/14

  • Revised rosters for Boards 2 and 5 available from Meeting Information page, Boards, effective 10/01/14.

08/21/14

  • Revised Board 4 roster available from Meeting Information page, Boards, effective 08/21/14.

08/18/14

07/14/14

  • Additional documents added to VA Resources and Documents link, effective 07/14/14.

06/09/14

  • Revised Board 1, Board 2, Board 3, and Board 4 rosters available from Meeting Information page, Boards, effective 06/09/14.

05/23/14

  • Revised Consent Template effective 05/23/14: Summary of Additions: In the What About Confidentiality section, required paragraphs for studies that include a Certificate of Confidentiality.

05/08/14

  • Revised Board 3 roster available from Meeting Information page, Boards, effective 05/12/14.

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.

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What's New Archived: 2005-2013

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