FAQs
How will the changes to the Common Rule affect NEW submissions to the IRB?
After January 21, 2019, new protocol submissions to the KPNW IRB will be required to use the updated consent and waiver templates that can be found in eIRB library. These templates contain the required elements (> 2018) to help you meet the requirements. If a study was approved prior to the 1/21/2019 effective date, it will remain under the old rule (< 2018) until its next continuing review. At that point, it is eligible to transition to the new rule (>2018) if there is benefit in doing so. If a study is approved on or after 1/21/2019, it will automatically be governed by the new rule.
The IRB will determine that some studies under the new rule will no longer require continuing review. When prompted for continuing review in the eIRB system, you will either respond if needed for submitting a modification, RNI, or closure under the new regulations (> 2018), or you will submit a full continuing review per the old regulations (< 2018).
How will the changes to the Common Rule affect my studies?
Existing Full Board Studies
Nothing will change for studies that were reviewed by a full board under the old rule (<2018).
Existing Expedited Studies
Some studies that were originally expedited by the IRB under the old rule (< 2018) will be eligible for less frequent review, beginning on 1/21/2019. In general, the IRB will require an annual check-in rather than a full continuing review to keep the study active, depending on the complexity of the study. A reminder for some kind of annual review will still be prompted in the eIRB system.
Existing Exempt Studies
There will be no changes to studies already determined to be exempt. If you have an exempt study that has ended, it is important to close the study with the IRB.
Additional requirements for federally funded studies
For each clinical trial conducted or supported by a federal department or agency, one IRB-approved consent form must be posted to a publicly available federal website (i.e., clinicaltrials.gov) after the trial is closed to recruitment and no later than 60 days after the last study visit for any subject.
What about Broad Consent?
The term “Broad Consent” as defined by the new regulations applies to consent for storage and secondary use of identifiable private information or biospecimens. This concept is implemented on an institutional level and requires tracking of individuals who decline to provide broad consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent, and therefore exclude their data from future research, KPNW generally does not recommend using Broad Consent at this time. Investigators can continue to use biospecimens that are coded or seek waiver of consent for use of biospecimens with identifiers retained following KPNW current practices. Investigators interested in exploring the possibility of using Broad Consent should contact the RSPO for guidance.
What if my study is FDA regulated?
FDA regulations are separate from Common Rule regulations and have NOT changed. FDA still requires annual continuing review for FDA-regulated studies, including minimal risk FDA-regulated studies.
Where can I find links to the new forms?
Please consult the eIRB library for revised templates and checklists.
Who can I call if I have questions about a submission or renewal?
Please call the RSPO office at (503) 335-3945 or contact the IRB staff member with whom you have been working.