Important Notice: Common Rule Implementation and Updated Guidance Documents/Templates Posted

 

Dear Research Community,

As of January 21st, 2019, the revised Common Rule has taken effect. The changes to the regulations do not require immediate researcher action ––researchers should continue to follow their IRB approved protocols and the determinations made by the IRB as communicated in the determinations letters (i.e. related to submitting CRs, Mods, and RNIs), etc. 

The IRB Office has already implemented the burden-reducing provisions per the Common Rule, which includes the elimination of continuing review for non-exempt, non-FDA/DOD, minimal risk studies (please refer to the IRB Office notice), and the clarification of what activities do not meet the definition of human research.  

Northwestern University’s IRB will not implement Broad Consent at this time because it is currently optional and formal guidance has not yet been disseminated by the regulatory agencies. Any attempt to implement Broad Consent prior to receiving additional regulatory guidance and appropriately bolstering the required infrastructure, will result in heavy administrative/compliance burdens for research study teams to keep track of refusals from research participants over time.

The IRB Office has made relevant updates to the Biomedical and Social and Behavioral protocol templates, as well as consent form templates. Please utilize these new template versions for any new projects and at the time of any modification involving protocol or consent form updates. Additional documents have also been revised per the Common Rule and all key documents can be found on the IRB Office website at:

Please review the updated Human Research Protection Program Plan (HRP-101) and the Investigator Manual (HRP-103).

The IRB Office website should be your first source for all documents. It is recommended that researchers refrain from saving frequently used documents but instead to always access the documents directly from the IRB Office website.

Please email the IRB Office at irb@northwestern.edu with any questions or concerns.

Thank you,

The Northwestern University IRB Office