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Attention: New applications for IRB review on or after January 21, 2019 must meet the requirements of the revised Common Rule. (See below)
Navigate to a type of submission to see details about what and how to submit to the IRB.
The federal regulations for the protection of human subjects known as the Common Rule have been revised, with a compliance date of January 21, 2019. The regulatory changes will only impact new federally funded studies that receive initial review by the Fred Hutch IRB on or after that date.
The IRO has prepared numerous revised policies and forms that will affect all submissions. Some forms were pre-released in November. Prior versions are no longer accepted for these forms:
Revised policies, consent templates, and some additional form updates are now available. To view the version and date changes, click here.
If you have any questions about these changes, please reach out to our office at iro@fredhutch.org. To view the revised 2018 Requirements directly, visit https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.
| Milestone | Date |
New Application versions pre-released |
Nov 19, 2018 |
Submission deadline for New Apps under pre-2018 Common Rule |
Dec 24, 2018 |
Last IRB meeting dedicated to New Apps under pre-2018 Common Rule |
Jan 9, 2019 |
2018 Common Rule compliance date |
Jan 21, 2019 |
No. Studies that received IRB approval before January 21, 2019, will continue under the prior Common Rule requirements. Fred Hutch does not currently plan to transition existing studies to the revised regulations.
Disapproved Studies:
If your study was disapproved by the IRB before January 21, 2019, you must re-submit on the new versions of the forms (in addition to addressing the IRB requirements as outlined in your IRB result letter).
Studies Approved with Minor Modifications:
Studies that were approved with minor modifications before January 21, 2019 are considered approved under the “Pre-2018 Requirements” of the Common Rule. You do not need to resubmit on the new versions of the forms. You only need to address the IRB requirements outlined in the IRB result letter.
FDA regulations have not changed. If you are submitting new research that is also federally funded, the revised regulations impact you.
For older studies, the IRB occasionally requests a de novo new application submission, to ensure compliance with current regulations and policies. If your de novo application will be reviewed by the IRB after January 21, 2019, the research must switch to the “2018 Requirements” of the revised Common Rule.
The initial effective date of the revised Common Rule was in 2018. Therefore, even though final compliance date is January 21, 2019, the regulations refer to “Pre-2018 Requirements” and “2018 Requirements.” Fred Hutch has adopted this terminology for consistency with published regulations and guidance.
OnCore CTMS is live for all study teams as of September 17, 2018. All submissions to the Fred Hutch / Cancer Consortium IRB must be sent via email to IRBinbox@fredhutch.org. This replaces all prior submission methods (paper and email routing to CRS), regardless of study type.
If you have any questions regarding the IRB submission process, please contact iro@fredhutch.org. For general questions regarding the CTMS project, please contact ctmspm@uw.edu.