The final revisions to the Common Rule (Federal Policy for the Protection of Human Subjects) became effective on January 20, 2020.  Accordingly, the IRB will implement the following changes. 

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. 

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.

Common Rule Regulatory Changes

Important Elements of the Final Rule: Continuing Review

Transition Plan: 

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.

• modifications for protocol changes

• adverse events, noncompliance and unanticipated problems

• DSMB and IDB reports

• key personnel roster updates

• protocol closure

• notice when personal identifiers are removed from the data/biospecimens and all codes and keys are destroyed

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.

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:

• The project is regulated by the Food & Drug Administration (FDA) or by another sponsor that requires continuing review

• An amendment or incident report reveals new findings that require additional oversight

• An administrative tool protocol has been received and the PI needs to develop and submit the human subjects protocol described in the grant application

• The investigator has had previous serious non-compliance or a pattern of non-serious non-compliance. In these instances the investigator will be notified along with justification for the continuing review requirement.

Summary: New categories and clarification of existing categories.  Some exemptions may require limited IRB review (similar to an expedited review process).

• Common Rule Exemption Changes Overview (PDF)

Summary: Changes to the Common Rule, the primary rule regulating human subjects research, went 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)

Common Rule Regulatory Changes

Important Elements of the Final Rule: Informed Consent

Transition Plan

• All medical and behavioral consent forms will now be required to include a concise summary of study activities, risks, and benefits presented to research participants, on page one of the consent document. The IRB will not require re-consent for previously enrolled subjects.

• To assist researchers in creating this new section a Plain Language Medical Dictionary has been added to the website to promote consent comprehension.

• Additional elements of informed consent (specific to biospecimens) are required to be included in consent forms – these are included in the  Medical Consent Template (DOCX) and  Repository Consent Template (DOCX)​ and are highlighted in BLUE.

• All studies approved after January 21, 2019 will be governed by the new rule.

• IRB applications submitted shortly before January 21, 2019 may not be reviewed in time to qualify under the current human subjects protection regulations. Applications undergoing the review process at the time of transition may be returned to the study team to update the informed consent elements.

• Existing protocols that are still enrolling subjects may or may not require revision based on other Common Rule changes. IRB analysts will make this determination at time of continuing review.

• The Research Protections Office has provided Concise Examples (DOCX) on how to apply this new element.

• If you have further questions about how to apply the new "key information" requirement for a particular study, contact your IRB Research Analyst for advice.

• The informed consent form must be posted on a Federal web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. Guidance is forthcoming on ClinicalTrials.gov.

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).

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.