Note that the Department of Health and Human Services has not issued any guidance for institutions on how to implement or interpret the New Rule. Policies and procedures may change as a result of evolving interpretations and guidance so be sure to check the website for updates.
- Exempt Studies: Past Exempt submissions will remain under the Pre-2018 Rule. Effective January 21, 2019, new exemptions will be accepted on the new forms and will be processed under the New Rule.
- New Expedited and Full Board studies processed after January 21, 2019 will need to be in compliance with the New Rule. This includes protocols that are submitted to the IRB prior to January 21, 2019 but processed on or after that date.
- Existing studies may or may not require compliance with the New Rule. IRB will determine the need for studies to transition.
- Investigators conducting studies that include written consent should be prepared to revise their current consent to include key information and applicable new elements.
- Cooperative research protocols received after January 20, 2020 must be in compliance with the New Rule. Existing cooperative research protocols will be grandfathered.
Continuing Review - compliance date January 21, 2019
Summary: No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.
Important Elements of the Final Rule | Transition Plan |
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Continuing Review | Ongoing PI Responsibilities If the RPO office has determined that annual continuing review forms are no longer required for a protocol, the PI and study team must continue to submit the following items.
Self-Review Checklist While the 2019 change does not require continuing review, it does require that the investigator notify the IRB when the protocol is closed. This can be accomplished by submitting a study closure through the UVMClick system. Instructions for submitting a study closure can be found on the UVMClick User Guides (opens in a new window). In order to assist researchers to remain in compliance with federal regulations and local UVM policies, the IRB will send an email reminder to all PIs and Key Personnel each January that will include a link to either the Medical (DOCX) or the Behavioral (DOCX) Annual Self Review Checklist. This form can be used any time during the year as an internal self-audit, but you will only receive a reminder from the IRB once a year. This tool has been developed for investigator/research staff use only, do not send completed form back to the IRB. If you find as a result of your self-audit that you need to submit materials to the IRB, please be sure to do so via UVMClick. Currently Approved Studies Expedited → RPO staff have determined which protocols fit the criteria for no further continuing review. Investigators and Key Personnel will receive an annual email reminder in January to assist you in remembering to submit protocol materials. Full Board → At the time of your next continuing review, RPO staff will determine if any further continuing reviews will be necessary. If no further reviews are necessary, you will receive a letter indicating this and you will no longer receive annual continuing reminders for that particular protocol. New Studies For new studies approved via expedited review on or after January 21, 2019, the IRB staff/member will determine the need for continuing review. If it does not, you will receive a letter indicating this and you will not receive annual continuing reminders for that particular protocol. Justification for Ongoing Continuing Review While the majority of expedited studies will not require continuing review, there may be reasons for maintaining the continuing review requirement such as:
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Exemptions - compliance date January 21, 2019
Summary: New categories and clarification of existing categories. Some exemptions may require limited IRB review (similar to an expedited review process).
Important Elements of the Final Rule | Transition Plan |
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Exemptions | Past exemptions are grandfathered. New projects will be reviewed under the new exemption categories as of January 21, 2019. |
Informed Consent
Summary: Changes to the Common Rule, the primary rule regulating human subjects research, go into effect on January 21, 2019. A number of UVM IRB policies, procedures, and systems have been updated as a result of the changes to the rule.
Investigators will see a number of changes required under the new rule specific to the Consent Form:
“The informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”
Revised Common Rule: Federal Register Volume 82, Number 12 (issued, January 19, 2017)
Important Elements of the Final Rule | Transition Plan |
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Informed Consent |
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Single IRB of Record - compliance date January 20, 2020
Summary: IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based).
Important Elements of the Final Rule | Transition Plan |
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Cooperative Research
| Past cooperative research protocols are grandfathered. New projects received after January 20, 2020 will adhere to the New Rule. |
Broad Consent - Not Implementing
Summary: In the revised Common Rule, Broad Consent is an (optional) alternative consent process for use only for the storage, maintenance, and secondary use of identifiable private information or identifiable biospecimens for future, yet-to-be-specified research.
Important Elements of the Final Rule | Transition Plan |
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Broad Consent | UVM is not transitioning to the broad consent plan as this change would require prospective consent for all leftover specimens from clinical care. This would have required the hospital to create systems to track the consent data on an institutional level. |