What's New (Norman Campus)

The IRB office has transitioned into a virtual office!
Our office is now telecommuting! We are continuing to process applications, answer phone calls and emails, and our reviewers are reviewing your studies!

Ways to contact us:
Phone: Please call the mainline at 405-325-8110.
We have forwarded the phones to our cell phones, so please do not hang up when the voicemail message comes on. After playing the voicemail message, the phone system will transfer to one of our cell phones. If you call after-hours and must leave a message, please do so. We are set up to receive voicemail alerts, so we will get back with you as soon as possible!

OU IRB Norman Campus Website:
https://compliance.ouhsc.edu/HRPP - under Researcher & Coordinator, select Norman Campus; Select tabs: Researcher’s Toolkit and/or Education & Training.
We have a lot of information on our website! This includes guidance on the application process, including step-by-step instructions on how to start a study, and templates that you will need to complete the process. We also have instructions on our website regarding the required CITI Social Behavioral Course training.

Emails:
irb@ou.edu
IRB Office

shelly.smith@ou.edu
Shelly Smith
IRB Administrative Assistant

kbraswell@ou.edu
Karen “Kat” Braswell
IRB Administrator

ncunningham@ou.edu
Nicole Cunningham
IRB Quality Improvement,
Education & Training Coordinator

sierra.smith@ou.edu
Sierra Smith
IRB Director

Monday, September 23, 2019
Norman Campus

Revised SOPs have been published on the HRPP website, effective 9/3/2019, and can be found here.  

TWO new SOPs have been published:

SOPs with a whole version number (e.g. 9, 10, 11...) contain revised and/or new content. 

SOPs with a "xx.1" version number (e.g. 9.1, 10.1, 11.1) contain formatting changes only. The content of those SOPs remain the same. 

Please contact your appropriate campus IRB if you have questions regarding the updated policies.  

Friday, March 1, 2019
Norman Campus

Dr. Randall Hewes, Interim Vice President for Research, has been designated to serve as the IRB's Institutional Official (IO). The IO is responsible for the conduct of human research and is the signatory official for the OHRP Federal Wide Assurance (FWA), all authorization agreements, and Department of Defense addenda. The role’s other main responsibilities include the authority to provide the necessary means to operate the HRPP program and enforce the independent nature of the relationship of the IRB within the University.

Tuesday, January 22, 2019
Norman Campus

Several policies have been updated to reflect changes due to the Revised Common Rule, which went into effect 1/21/2019. The effective date of these policies is 1/21/2019. The Searchable SOP link has also been updated. You can access all of the SOP's on the Policies and Procedures page.

Friday, December 15, 2017
Norman Campus

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

 

Summary of major changes that affect the research community:

    • Changes to the informed consent policy and minor changes to the templates
    • Continuing review for certain minimal risk research (Expedited studies and Full Board studies in data analysis only) may no longer be required
    • Various clarifications and the addition of new categories of Exempt research
    • Single IRB of Record (sIRB) requirements for multi-site studies (effective January 25, 2020 – for NIH studies, effective date is January 25, 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 for implementation of 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. 

Studies approved January 19, 2018, and beyond must meet the updated requirements of the “2018 Rule”, and are subject to the updated consent, continuing review, and exemption regulations. Studies approved before January 19, 2018, will be transitioned to the updated regulations at the time of their next continuing review. Exempt studies will remain under the previous Common Rule requirements.

More information will be provided on the HRPP/IRB website as it becomes available. Please let us know if you have any questions or concerns!

*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.

Friday, December 15, 2017
Norman Campus

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

 

Summary of major changes that affect the research community:

  • Changes to the informed consent policy and minor changes to the templates
  • Continuing review for certain minimal risk research (Expedited studies and Full Board studies in data analysis only) may no longer be required
  • Various clarifications and the addition of new categories of Exempt research
  • Single IRB of Record (sIRB) requirements for multi-site studies (effective January 25, 2020 – for NIH studies, effective date is January 25, 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 for implementation of 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. 

Studies approved January 19, 2018, and beyond must meet the updated requirements of the “2018 Rule”, and are subject to the updated consent, continuing review, and exemption regulations. Studies approved before January 19, 2018, will be transitioned to the updated regulations at the time of their next continuing review. Exempt studies will remain under the previous Common Rule requirements.

More information will be provided on the HRPP/IRB website as it becomes available. Please let us know if you have any questions or concerns!

*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.

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OUHSC Contact

865 Research Parkway, Suite 400
Oklahoma City, OK 73104

ph: (405) 271-2045
fax: (405) 271-1677


Email Us: irb@ouhsc.edu

Norman Contact

Five Partners Place
201 Stephenson Parkway, Suite 4200
Norman, OK 73019

ph: (405) 325-8110


Email Us: irb@ou.edu