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.
Great news! We have changed our CITI approval period from 2 years to 3! You will now have an extra year until you must complete the Refresher Course.
New Review Board rosters are available. These are effective 08/01/2017.
On Sunday, April 16, 2017, from 6 AM to 2 PM, iRIS may experience intermittent connectivity due to scheduled maintenance efforts. We apologize for the inconvenience!
We have upgraded iRIS to the newest version. Some of the changes are noted below:
- Your Home screen will now contain buttons for actions related to your studies. For example, the "Add a New Study" and "My Studies" buttons are now immediately available on the Home screen.
- The process for responding to stipulations has changed slightly. Please see the "How To" page for guidance on this process.
- We have created a new application that is specific to Norman Campus researchers. It contains all of the Protocol Description form questions; therefore, that form will no longer be required as an uploaded document. Please see the "How To" page for guidance on submitting this new version of the form.
- You will now have the ability to hide documents no longer in use. Open your study, click on either the Informed Consent or Other Study Documents link in the top left. Click the Hide button (far right) next to the documents you wish to hide. There is a button at the top of the screen to allow you to still see any hidden documents.
We have also uploaded new consent form templates. These are condensed versions of our existing templates. They contain only the bare essential information and no longer have a lot of the conversational elements found in the full versions of the templates. These are optional to use; you still have the opportunity to use the full versions, if you would prefer. Please see the Application Forms page for more information.
We will be upgrading iRIS during the week of Spring Break (March 11th – 19th). The system will be unavailable for submissions during this time, and we will not be able to access or review studies. We apologize for the inconvenience!
New Review Board rosters are available. These are effective 01/15/2017.
The 2017 Board meeting schedule has been published on the IRB Board Rosters & Schedules page.
We have updated the iRIS "Add a New Study" tab to include a new option for "Relying on an External IRB" requests. You would only choose this option if you are requesting the OU IRB to defer IRB review and approval to an outside institution associated with your study. If you are wanting to submit a typical study application, Protocol Development form, or Determination of Human Research Worksheet, you will select the first "Application" option. Please contact us if you have any questions! 405-325-8110 or firstname.lastname@example.org
iRIS will be down for server maintenance on Sunday, September 18, 2016, from 6AM - 4PM. We apologize for the inconvenience!
New Review Board rosters are available. These are effective 09/01/2016.
We have the revised the Board meeting schedule to note that only one Board a month will meet, rather than both Boards. This decision is due to the decrease in Full Board studies/submissions being reviewed. If a study is submitted that requires Full Board review and it cannot make it onto the monthly agenda, we will attempt to schedule an impromptu meeting to minimize any time delays.
Information Technology will perform routine monthly server maintenance on Sunday, August 21, 2016 from 7AM - 2PM. iRIS may experience intermittent connectivity during this time.
Recently, the Association for Accreditation of Human Research Protection Programs (AAHRPP) distributed a newsletter illustrating the average review times for accredited IRBs. We compared our average review times to the national averages for each of the different categories in the graph below.
A very special thank you to our reviewers, administrators, and researchers for helping make our averages so low!
iRIS will be down for maintenance on Sunday, July 31, 2016, from 8AM to 2PM. We apologize for the inconvenience.
New Review Board rosters are available. These are effective 07/01/2016.
On Sunday, July 17, 2016 from 6AM to 2PM, the iRIS service may experience intermittent connectivity due to scheduled maintenance efforts.
iRIS will be down for maintenance on May 25, 2016, from 7PM to 11PM. We apologize for the inconvenience.
On or about 4/21/2016, we experienced a disk storage issue with our iRIS Research Submission System. The net effect of this issue was the loss of data in forms or completed forms that were submitted during that day or possibly the day before.
If you have entered any forms into the iRIS system, submitted any new Applications, Continuing Review Forms, Modifications, etc., or responded to a Review Response Form during this time, you can contact the IRB to make certain that the submission was received.
This recent issue has been resolved and we are working with Information Technology to insure that it does not happen in the future. The IRB/HRPP apologizes for any inconvenience this may have caused.
Thank you for your understanding.
This past January, our Training Coordinator participated in a series of video interviews with Dr. Jim Martin, Director of OU's Zarrow Center for Learning Enrichment. William Farrell in the Center for Teaching Excellence produced the videos and has written a blog post about the experience.
Check it out: http://bifffarrell.com/blog/ed-tech/#irb
Our office will be moving to a new location on March 1, 2016. Our new address will be 201 Stephenson Pkwy (5 Partner's Place), Suite 4300A, Norman, OK 73019. We will not be accessible by telephone as we move, but we will have access to our email and iRIS. Please email email@example.com or leave a message if you call and we do not answer. We will respond to your inquiries as soon as possible!
The 2016 Spring IRB Graduate Student Training will take place on March 4th from 11AM - 1PM and March 7th from 5PM to 7PM. Please see the Graduate Student Training flyer for additional details.
We have released the Brown-Bag luncheon schedule and list of topics for 2016. See the Education/Training page for more details.
New Board member rosters are available. These are effective February 1, 2016.
The Department of Health and Human Services (HHS) has announced proposed changes to the regulations. Click HERE to access links/resources for learning about the proposed changes.
Like us on Facebook to stay up-to-date on submission tips and scheduled education/training sessions!
New Review Board rosters are available. These are effective 09/01/2015.
Our office has moved to a new location. The new address is Five Partner's Place, 201 Stephenson Parkway, Suite 1300A Norman, OK 73019.
The telephone number and email addresses remain the same.
New Review Board Rosters are available. These are effective 04/01/2015.
New "Researcher Consent Guidance" is available in the Application Forms section. The IRB provides templates for the researcher to use when obtaining consent. There are different types of templates available and the guidance provides the researcher with the information needed to identify which consent form to use.
An updated version of the Investigator Manual is now available. Please see, SOP 801 located in the OU-NC Policies link. This is effective 02/03/2015.
New Review Board Rosters are available. These are effective 01/15/2015.
Conflict of Interest policies have been updated, effective 12/31/14. The policies are available in the OU-NC Policies section of the IRB website
New Review Board Rosters are available. These are effective 10/15/2014.
New Review Board Rosters are available. These are effective 09/12/2014.
New Review Board Rosters are available. These are effective 08/15/2014.
New Review Board Rosters are available. These are effective 06/01/2014.
Newly appointed Institutional Official, Dr. Glen Krutz.
New Review Board Rosters are available. These are effective 01/13/2014.
New Policies and Procdures (PDF's) are available. These are effective 08/22/2013.
New Review Board Rosters are available. These are effective 06/17/2013.