Revised Common Rule 45 CFR 46 Effective on January 21, 2019

Monday, January 7, 2019
By Duke Office of Clinical Research (DOCR)
Revised Common Rule 45 CFR 46 Effective on January 21, 2019

As you know, the revised Common Rule 45 CFR 46 will take effect on January 21, 2019.  Your studies will be affected in the following ways:

 NEW STUDIES
  1. Any new studies, including exempt studies, submitted in iRIS (final PI signature in place) on or after 01/21/2019 must be consistent with the revised Common Rule.  This means that consent forms must begin with a Concise Summary and contain the new required Elements of consent.  For examples of Concise Summaries, please click here.  
  2. Please do not use an old approved consent form as your starting point if you are creating a consent form for a new study.  Use the Sample Consent Template on the IRB website, because it contains the new required Elements for compliance with the new regulations.
  3. Likewise, the waiver of Consent/HIPAA authorization has been modified to contain new required language and has been embedded in the iRIS application since iRIS Go-Live. 
  4. New minimal risk studies that receive an expedited review (upon initial review) will be assigned a 2 year approval period upon completion of the IRB’s initial review.

 

Please note: All FDA-regulated studies are unaffected by the revisions to the Common Rule, and renewals must continue to be submitted annually, or more frequently if required by the IRB, using the current progress report template.

 

EXISTING STUDIES
  1. Throughout 2019 until 01/21/2020, all existing studies must submit a renewal (continuing review) to DUHS IRB according to the current schedule (45 days prior to the current expiration date).
  2. For renewals of existing studies submitted on or after 01/21/2019, a study team may opt to conduct the study under the old Common Rule or transition to the revised Common Rule for the remaining life of the study. 
  3. A choice will be offered in the annual progress report in iRIS to indicate the study team’s preference.
  4. If your study is not FDA-regulated and meets any of the following criteria, it would qualify to transition to the revised Common Rule:
    • initial review was completed via the expedited process and that status has never changed (minimal risk studies);
    • greater-than-minimal risk studies which are now in a data analysis phase only--these studies are closed to enrollment and all participants have completed all study activities;
    • greater-than-minimal risk studies where enrollment is closed, and the sole remaining study activity is collection of clinical data that would normally be part of standard care.
  5. If choosing to transition to the revised Common Rule, the study team will have to ensure that a Concise Summary and the new required Elements are added to the consent form via an amendment.  Every two years thereafter, the study team will have to complete an abbreviated progress report (two-year check-in).  This abbreviated progress report will reside in iRIS after 01/21/2019.  Approval notices sent out by the iRIS system will reflect the new change to two-year check-ins for studies transitioning to the revised Common Rule.
  6. A study team that opts to continue the study under the current Common Rule will continue to complete annual Continuing Reviews and will not have to revise the consent form.

 

AMENDMENTS
  1. Submission timelines for amendments are not affected by the revised Common Rule; all changes to previously approved research are required to be reported via amendment to the IRB for review and approval, per current practice.
  2. The IRB may require addition of the Concise Summary and the new required Elements to the consent form of an existing study to be conducted under the revised Common Rule if other changes are also being made to that document.

 

SAFETY EVENTS

Submission timelines for safety events are unaffected by the revised Common Rule and should proceed per current practice.

 

WAIVERS

If a study team opts to conduct an existing study under the revised Common Rule, the current IRB-approved waiver will need to be replaced by the revised waiver.  The revised waiver can be accessed via an amendment to the application.

 

REFERENCE

For a more detailed summary of the revisions to the Common Rule, including more information on biorepositories and databases, please follow this link:  https://irb.duhs.duke.edu/about-us/irb-news/key-points-new-common-rule-communication-research-community  
Please keep this summary for your reference, and contact the IRB Board Specialist for your department/CRU if you have additional questions. 

 

REMINDER FROM DOCR:

For each clinical trial supported by a federal department or agency, one IRB-approved consent form must be uploaded to a publicly available federal website after enrollment has closed. To facilitate compliance with this requirement, any federally-supported clinical trial with initial IRB approval on or after January 21, 2019 will need to be registered on ClinicalTrials.gov before receiving full institutional approval in OnCore. After enrollment has closed, one IRB-approved consent form will need to be posted in the ClinicalTrials.gov record. This consent form can be posted by the study team in ClinicalTrials.gov at the same time they are making status updates and editing completion dates. DOCR will provide support. Please contact DOCR-ctgov@duke.edu for questions or assistance.