12/7/2018 2
Published: Friday, December 7, 2018
** 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:
- Changes to the informed consent process, including documents and documentation
- Continuing review for certain minimal risk research may no longer be required
- Various clarifications and addition of new categories of exempt research
- Single IRB of Record (sIRB) requirements (effective January 25, 2020 – for NIH studies, effective date was January 25, 2018).
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:
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Dec. 20, 2018
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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.
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Dec. 21, 2018 – Jan. 15, 2019
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Time needed for IRB to review new studies submitted prior to December 20, 2018, get responses for stipulations, and grant final IRB approval.
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Jan. 16, 2019
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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.
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Jan. 22, 2019
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iRIS back online to accept all submission types.
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Jan. 15 & 16, 2019
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Education Town Halls for OUHSC research community (including videoconference to the Tulsa campus)
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Dec. - Jan. 2019
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Update and publish guidance on HRPP website; post new consent template(s), policies and procedures, and transition details.
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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.