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New Common Rule Announcement

New Common Rule Announcement

 

WVU’s Office of Research Integrity and Compliance announcement on new “Common Rule” guidelines:

 

There has been a Delay of the Revised Common Rule.

 

On January 17, 2018, an interim final rule moved the effective date of the Revised Common Rule to July 19, 2018.

 

It is important to share that we currently perform at this higher level of review, and already meet this new guideline, by having our Human Subjects’ Compliance team review all protocols before they go to the IRB for review and approval.

 

For all research, including federally funded research, we will be providing a refined Informed Consent form, which will include an “executive summary” and more detailed instructions with guidance on how to write a ‘concise and focused presentation of the key information’ as required under section .116 of the new rule.

 

Minimal Risk Research:  For research, including federally funded research, the new rule provides new parameters for the continuing review of most minimal risk research. These parameters will be established at the discretion of the institution.  The HRPP office already has a process to evaluate potential studies that may not need IRB review.  Our NHSR and Exempt protocols are reviewed by the administrative staff to either acknowledge that WVU is aware of the work being performed by our faculty or staff or to send it to IRB members for their review.

 

For the other aspects of the Common Rule, we are working on new guidelines to assist in protocol development and provide guidance to investigators to navigate the implemented changes.

 

We remain in compliance with the current common rule and are working diligently to implement the required changes as described in the new Common Rule; however, changes in regard to the new common rule that conflict with the pre-2018 rule, may not be implemented until after July 19, 2018, or any further extensions.  We will be actively communicating any updates we make to our current processes and procedures as they occur. 

 

Please let us know if you have any questions.