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July 19, 2018 - Implementation of New Common Rule Regulations

On July 19, 2018, the Federal Government implemented a delay in the revised regulations governing human subjects research known as the Common Rule. The revised Common Rule effective date is now January 21, 2019.

There is an exception to this general rule. Institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the revised Common Rule effective July 19, 2018. Those three provisions are:
1.    The revised definition of “research,” which deems certain activities not to be research covered by the Common Rule;
2.    The elimination of the requirement for annual continuing review with respect to certain categories of research; and
3.    The elimination of the requirement that institutional review boards review grant application or other funding proposals related to the research.

Below is information on how the IRB will be implementing these provisions effective July 19, 2018.

Revised Definition of Research

IRB analysts will apply the new definition of research when reviewing applications submitted for IRB review. Researchers do not need to take any action to request the application of this revised definition.The IRB application process for these reviews has not changed. If you would like the IRB to determine that your project is not subject to Common Rule Regulations, please click here to follow the "Is IRB Review Required" Guidance

Elimination of Continuing Review Requirements

The IRB can elect to remove the continuing review requirement for the following types of active studies:
-    Research determined to be minimal risk and eligible for expedited review, categories 1-7 and 9
-    Greater than Minimal Risk Research that has progressed to the point where it only involves the following activities
     o    Data analysis, including analysis of identifiable data and specimens
     o    Collecting follow-up clinical data from procedures that subjects would undergo as part of clinical care
If the IRB determines that these regulations can be applied, IRB approval will not expire and continuing review applications will no longer be required. However modifications and reportable events should still be submitted.

If you have a currently active study, you should continue to operate under the old common rule regulations. If your approval is set to expire, you should submit a Continuing Review application.

At the time of your next continuing review or protocol modification, IRB staff will determine if the new regulations can be applied.

Your IRB approval letter will include an expiration date or a notice that continuing review is no longer required.

This review won’t be done for administrative modifications (personnel changes, recruitment flyers, etc.) unless you ask for it directly.If you receive an approval letter that includes an expiration date and you feel that the new regulations should have been applied, please contact Patrick Stanko, IRB Assistant Director, to discuss the matter. Click here for contact information

IRB Review of Grant Applications

The IRB will not be implementing this provision during the delay period. Please continue to include a copy of your grant in your application to the IRB. This is required for all federally funded studies.

 

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