How do I stay up to date on the latest from RCS and the Common Rule changes?
As we make changes to materials and processes and as new information is available, we will post the latest news and updates on the Revised Common Rule webpage. See the links in the sidebar to the left for the most recent updates and news.
Updated materials and resources were developed and will be available on our website to ensure the UO research community is prepared for the revised Common Rule. See the links in the sidebar to the left for the most recent updates and news.
I am in the middle of preparing a new submission to the IRB. How do the changes affect new submissions?
Continue to prepare your submission as you would. We are updating our submission materials and resources to guide you through the key changes to the regulations. Materials are being posted to our website as they become available. When preparing submissions to RCS, be sure to download forms directly from the website as you will want to use the most recent version available.
We will continue to accept previous versions of forms through the transition. Any new studies approved on or after January 21, 2019 will be reviewed under the revised Common Rule regulations, even if the protocol is submitted using prior versions of our materials
Key changes to the revised Common Rule include revised criteria for informed consent, new and revised categories for exemption, and eliminating continuing review requirements for some minimal risk research.
I am in the middle of preparing a continuing review or amendment for an existing ongoing study, what should I do?
Investigators will need to continue preparing and submitting amendments and continuations to maintain compliance for existing studies that were previously approved or determined exempt. We will continue to accept previous versions of the forms throughout the transition. You will continue to work off of the previously approved iterations of your protocol materials.
Do not update materials to address Common Rule changes until you have been assessed for transition by RCS. Some studies will not require updates to materials to be transitioned (e.g., transitioned from Expedited under the pre-2018 Common Rule to now being Exempt under the 2018 Common Rule).
How do these changes affect my existing or ongoing research and what do I need to do now?
The revised Common Rule requires existing research (approved or determined exempt prior to January 21, 2019) to remain compliant with the pre-2018 regulations. The revised Common Rule affects only new studies reviewed and approved or determined exempt on or after January 21, 2019. Therefore, for existing studies, researchers do not need to take any action at this time beyond maintaining active IRB approval, including submission for continuing review (unless previously granted exemption).
Can my existing study be transitioned to oversight under the revised Common Rule?
If your study has been reviewed and approved or determined exempt under the pre-2018 Common Rule, there is opportunity to transition the study under the revised Common Rule, but transitioning is not required at this time. Transitioning may or may not be in the best interest of your research.
Existing research can be transitioned to operate under the revised Common rule only after being reviewed and determined to comply with the revised Common Rule. To be brought into compliance with the revised regulations, existing studies may require substantial revisions.
To assess whether to transition existing research to operate under the revised Common Rule, RCS will work with researchers in advance of a study’s existing expiration and/or when an amendment is submitted. In some cases, it may be best for a project to remain under the pre-2018 regulations. In other cases, it may be best to transition an existing project to operate under the revised Common Rule.
Can I request that my existing study be transitioned to the revised Common Rule?
Yes. RCS will be routinely assessing studies for transition readiness in advance of a study’s existing expiration and/or when an amendment is submitted. However, an investigator may independently request a study be assessed for transition by submitting an amendment specifically requesting the study be considered for transition to the revised Common Rule.
I have an existing, ongoing study. Do I still need to submit for continuing review?
Yes. It is important that investigators maintain continuous approval for protocols previously reviewed under the pre-2018 Common Rule. If a study lapses, a reactivation under the pre-2018 Common Rule will not be possible. A new study application will be required as the study would need to then be reviewed and approved under the revised 2018 Common Rule. As a reminder, not all studies will benefit or be a good fit for transition as they may require substantial revisions to be in compliance with the revised rules and changes may disrupt ongoing research.
Investigators must continue to submit continuing review applications at least 45-days in advance of the study expiration. Upon receiving the continuing review application, these studies will be assessed to determine if they are a good fit for transition under the revised 2018 Common Rule. RCS will communicate the outcome of the assessment and work with investigators if transition is recommended.
If a study is transitioned to the revised Common Rule, the study will be reviewed and the requirement for continuing review will be determined at that time. Some studies that transition may no longer require continuing review for subsequent years of the study’s approval.
Will the exempt review process change with the revised regulations?
Yes. RCS has revised the exemption submission and review process. A new Exempt Review Application and complimentary Exempt Category Worksheets have been developed and posted. Additionally, an online self-assessment tool has been created to assist researchers in determining if their study may qualify for exemption. Investigators can also use the application and worksheet(s) to preliminarily assess whether their study qualifies for exemption. Once an investigator self-determines that the study may qualify for exemption, completed forms need to be submitted to RCS for verification of the exempt determination. If additional information is needed or the study does not qualify for exemption, RCS will guide investigators to further submit. Otherwise, investigators will need to await a formal letter of exempt determination from RCS before initiating human subject research activities.
The forms have been streamlined to solicit only the information necessary for our office to make an exempt determination. Forms should be saved and retained for future submissions. The same application form is used for initial review as well as amendment reviews to verify a study continues to qualify for exemption.
What does Broad Consent mean in the revised Common Rule?
The revised Common Rule includes a new term, Broad Consent. Broad Consent is an alternative to informed consent for storage and secondary research of identifiable private information or identifiable biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from the Office of Human Research Protections in the U.S. Department of Health and Human Services and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, UO will determine at a later time whether to implement broad consent procedures. Investigators can continue to use biospecimens that are coded or to seek waiver of consent for use of biospecimens with identifiers retained consistent with current practices. Limited exceptions may be considered after thorough consultation with RCS to determine if Broad Consent is appropriate. Investigators must consult with RCS if interested in pursuing research that involves Broad Consent.
Will other changes be made soon?
With any transition comes adjustments. As we work with the revised Common Rule, we anticipate additional changes and adaptations may be necessary. In addition, we continue to await further federal guidance on the implementation of these revised regulations. We will keep the research community apprised of any new information; stay tuned to our Common Rule web page.