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Human Subjects Research
Common Rule Changes : Email Notice
On January 21, 2019 the Oklahoma State University Institutional Review Board (OSU IRB) will implement the Revised Policy for the Protection of Human Subjects (i.e. Revised Common Rule). This communication is to provide you with additional information regarding this process.
Investigators are strongly encouraged to delay the creation of a New Application for Review of Human Subjects submissions until January 21, 2019. A new version of the IRB application (version 4) will be released to comply with the Revised Policy for the Protection of Human Subjects (i.e. Revised Common Rule) on that date.
If your submitted IRB protocol cannot be approved before January 21, the submission will be withdrawn and the IRB Office will provide you with a PDF version for use in resubmitting after January 21 on the new version of the form when the Revised Common Rule is implemented in IRBManager.
All applications in progress (not yet submitted) on versions 1-3 of the IRB application, will be deleted in IRBManager on March 1, 2019. Please download a PDF version for your personal use or transfer all information into the newest version by that date. Instructions are available on the IRB Manager Support Page on the OSU IRB Website. Please look under “View as PDF” in the General Support Information section.
NO FEDERAL GRACE PERIOD FOR IMPLEMENTATION
January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule. This means that we cannot implement the revised rule before the effective date. It also means the regulation provides no grace period for which to transition to become compliant with the revised rule.
All initial applications submitted under the current rule, must obtain approval prior to January 21, 2019.
All initial applications submitted after the effective date must comply with the new elements and regulatory requirements of the revised rule.
FDA-Regulations have not yet harmonized with all of the Revised Common Rule provisions. However, we will implement those changes that do not conflict with current FDA regulations.
Research approved prior to January 21, 2019 may continue through completion based on the Current Common Rule regulations.
Existing projects will be assessed at the next continuing review to determine if they should transition to the new Revised Common Rule. Moving a project to the new rule means the entire new rule applies. This may require revisions to the informed consent form, reconsent of participants, and increased data security and privacy standards for these existing studies.
SUMMARY OF REVISIONS TO THE COMMON RULE
A brief summary of the Revisions to the Common Rule can be found on the OSU IRB website homepage under Frequently Asked Questions on the bottom right of the page. The major revisions include the addition of new exemption categories, changes to the required elements of consent, and changes to continuing review.
Please contact the OSU IRB Office at 405-744-3377 or email@example.com if you have any questions.
Dawnett Watkins, CIP
Whitney McAllister, MS
Oklahoma State University
Institutional Review Board
Office of University Research Compliance
223 Scott Hall, Stillwater, OK 74078
Ph: 405-744-3377 | Fax: 405-744-4335| firstname.lastname@example.org