Common Rule Changes and Continuing Review

 

NEW -  Important Information for Investigators with International Collaborations

Common Rule Changes and Continuing Review

January 3, 2019

As we are getting closer to the implementation of changes to the Common Rule we would like to continue communicating these changes to the research community. Another major change to the Common Rule is the elimination of the requirement of continuing review for all minimal risk research submitted on or after January 21st, 2019**. Reviewers will still have the option to require continuing review to enhance the protection of human subjects for particular studies on a case-by-case basis.

There will be a requirement to submit a “status update” every two years. The update method (continuing review or “status update”) will be specified in the initial approval letter. We are asking that the following be included in the “status update”:

Status of the study (actively recruiting, closed to enrollment, etc.)
Training of study personnel
Change in personnel (if applicable)
Conflict of Interest information (if applicable)
Redacted consent (for QA/QI purposes
Unanticipated problems/serious adverse events (if applicable
Changes to the study including changes to the consent form (if applicable)
Funding (if applicable)

You can find the “Research Status Report form” located in IRBnet library.

Although the renewal requirements have changed with the Common Rule, the amendment process remains the same. All changes to a study must be submitted and approved before they can be implemented. Additionally, the consent form will no longer have an expiration date. You will still continue to see an expiration date on the study, as a status report would be due every 2 years.

Continuing review requirements still apply to research reviewed by the IRB that is greater than minimal risk research unless the research involves one or both of the following:
Data analysis, including analysis of identifiable private information or identifiable biospecimens;
or
Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care

**Please Note: Any studies approved prior to January 21, 2019 will fall under the current common rule guidelines and are required to undergo continuing review annually

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