RPOHuman Subjects ResearchRegulationsRegulatory Changes

 

Revised Common Rule

Implementation and Transition

The final revisions to the Common Rule (Federal Policy for the Protection of Human Subjects) will become effective on January 21, 2019.  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.

 

 

Continuing Reviewcompliance 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

Transition Plan

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.

  • 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 (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 an File Annual Self-Review Checklist for Expedited Protocols form (DOCX). 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.

 

 

Exemptionscompliance 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).

Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

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)


Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

Informed Consent

  • 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 File Medical Consent Template (DOCX) and File 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 File 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.

 

 

Single IRB of Recordcompliance 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).

Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

Single IRB of Record (sIRB)

UVM will not transition to this rule until the IRB has more experience with sIRB projects funded by the NIH.

January 20, 2020

 

 

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.

Common Rule Regulatory Changes
Important Elements of the Final Rule

Transition Plan

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.

 

Introduction

  • In December 2016, the United States enacted the 21st Century Cures Act (Cures).
  • On a similar timeline, in January 2017, the U.S. Department of Health and Human Services (HHS), along with 15 other federal departments and agencies, issued a final rule updating the Policy for the Protection of Human Subjects (also referred to as the “Common Rule”).

More About Cures...

Enactment of Cures was the culmination of a bipartisan, multi-year effort by Congress to modernize the cycle of discovery, development, and delivery of innovative medical products.

Cures authorized resources for the National Institutes of Health (NIH) to support biomedical research through the funding of basic, translational, and clinical research.  Cures gave the NIH the tools and flexibility to alleviate administrative burdens that can hamper biomedical innovation, increase data sharing among NIH-supported researchers, authorize innovation prize competitions, support high-risk, high-reward research, increase funding opportunities for young investigators, improve privacy protections in research volunteers, and encourage the inclusion of diverse populations in clinical research.

In Sec. 2034. Reducing Administrative Burden for Researchers, the Secretary of HHS is required, within two years of enactment, to make revisions to harmonize existing regulatory policies and reduce administrative burden.

Additionally, Cures provided the Food and Drug Administration (FDA) with new authorities to modernize the regulation of medical products throughout the lifecycle of discovery, development and delivery.

More About the Common Rule...

The Common Rule is the set of regulations governing the conduct of human subjects research conducted or sponsored by the federal departments and agencies that subscribe to the rule. UVM applies the Common Rule to all human subject research conducted at the two institutions.

The FDA has not signed onto the Common Rule changes and therefore FDA regulated studies are not currently subject to these Common Rule changes.  However, as mandated by the Cures Act, HHS and the FDA must work together to harmonize long-standing differences within the next three years.

We have created this web page to provide a snapshot of all the regulatory changes. As these deadlines approach, we encourage you to check this web page periodically for updates.