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Revisions to the Common Rule and Their Application


The mandatory compliance date for implementation of reviseions to the Common Rule is January 21, 2019. As of that date, any study approved under the Common Rule must meet the requirements of the revised version of the regulations (also referred to as the 2018 Requirements.)


The “Common Rule” is a term used to refer to the Federal Policy for the Protection of Human Subjects, 45 CFR 46, which outlines the criteria and mechanisms for IRB review of government-funded human subjects research, adopted by multiple agencies in the interest of harmonization. The Food and Drug Administration (FDA) is not an agency under the common rule, and maintains their own regulations for Good Clinical Practice and Clinical Trials, which are not affected by this change at this time.

Any study approved by E&I IRB·before January 21, 2019 will continue to be required to comply with the Pre-2018 Requirements until their next scheduled continuing review, at which time (or anytime thereafter) a request for modification to transition to the revised rule may be submitted.

The choice to transition a study to the revised rule is voluntary for those approved prior to January 21, 2019. Transitioning to the revised rule includes changes that could present the potential for both benefits and burdens to the research team. For minimal risk studies approved under expedited process, the revised regulation permits the elimination of continuing review for some studies, which may reduced burden to the research team, but should be carefully weighed against the additional requirements for significant modifications to the study’s consent form(s). Careful consideration should be given to the Overview of Common Rule Revisions and to the Revised Common Rule Frequently Asked Questions, when deciding whether or not to transition.

 

For more assistance, please feel free to contact E&I if you would like to discuss the specifics of transitioning your study.

 

 

 

 

Last Updated ( Thursday, 17 January 2019 12:56 )