** REVISED COMMON RULE ANNOUNCEMENT: IMPLEMENTATION & FREEZE ON NEW RESEARCH APPLICATIONS **
Implementation of the final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule”) will go into effect on January 21, 2019.
Summary of major changes that affect the research community:
iRIS will go offline in January prior to implementation of the Revised Common Rule
The University’s Human Research Participant Protection (HRPP) offices will close iRIS for a few days to implement and test the regulatory changes in the system. Below is the planned timeline:
Dec. 20, 2018
iRIS will be closed to new study submissions on Dec. 20th at 5:00 p.m.
Continuing reviews, Modifications, Determination Worksheets, and other submissions will continue to be accepted.
Dec. 21, 2018 – Jan. 15, 2019
Time needed for IRB to review new studies submitted prior to December 20, 2018, get responses for stipulations, and grant final IRB approval.
Jan. 16, 2019
iRIS goes offline for transition to RCR and testing. No users will be able to submit to the IRB; no IRB reviews will be conducting during this time.
Jan. 22, 2019
iRIS back online to accept all submission types.
Jan. 15 & 16, 2019
Education Town Halls for OUHSC research community (including videoconference to the Tulsa campus)
Dec. - Jan. 2019
Update and publish guidance on HRPP website; post new consent template(s), policies and procedures, and transition details.
NOTE: The above schedule should allow enough time for the HRPP / IRB to complete its review of submissions prior to January 21st to remain under the “pre-2018 Rule.” Research approved January 21, 2019 and beyond must meet the updated requirements of the “2018 Rule”, and is subject to the updated consent and exemption requirements.
Exceptions to the above schedule or urgent submissions will be considered for acceptance on a case-by-case basis. Please contact the HRPP Office at 405-271-2045 prior to submitting any new studies in iRIS during the new study “freeze” window.
More information will be provided on the HRPP/IRB website as it becomes available. Feel free to contact the HRPP Office at 405-271-2045 if you have any questions or concerns. Thank you.
New OUHSC links added for: REDCap, OSCTR, OCTSI, and SoonerTrack. Explore these resources on the Links... page!
New submission guidance for research activities - with links to iRIS instructions - added to the Submission Process Guidance page.
865 Research Parkway, Suite 400Oklahoma City, OK 73104
ph: (405) 271-2045fax: (405) 271-1677
Five Partners Place201 Stephenson Parkway, Suite 4300ANorman, OK 73109
ph: (405) 325-8110