Dear Colleagues,

KR will be down this evening from 8PM-9PM. Along with a few technical updates, a functional change of interest is:

Due to changes in the 2018 Revised Common Rule congruence review language (explicitly clarifying that it’s the institution’s responsibility to perform the congruence review) within the federal register is located on page 1363:https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects#p-1363

And

The Final Rule for the 6-month delay, explicitly clarifying that congruence reviews are not the IRB’s responsibility, is located on page 106 (https://www.federalregister.gov/d/2018-13187/p-106) and page 185 (https://www.federalregister.gov/d/2018-13187/p-185).

The approval text is revised to read:

Approval indicates that information in the proposal and KR is complete and accurate to the best of your knowledge. Approval confirms any cost sharing commitments, space arrangements, and resources for the project. The PI, Co-PI, and others involved in the project are not currently debarred, proposed for debarment, suspended, declared ineligible, or voluntarily excluded from transactions by a federal agency. If awarded, the PI, Co-PI, and lead unit agree to be responsible for the fiscal and scientific conduct of the project as required by law, sponsor regulations, award terms, and university policy. If this proposal is being submitted to a Federal Agency and the scope of work includes human subject research, the PI also certifies that the subsequent IRB application submitted for this project will be identical in principle and congruent with the scope of work outlined in the attached proposal application. Further, the PI will submit modifications and/or changes to the IRB, as necessary, to assure the proposal/award and application continues to be congruent and identical in principle.

A screenshot of the approval screen is below:

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Please email era@research.uci.edu if you have any questions about this one hour downtime.

Barbara

Barbara Inderwiesche, CRA

Assistant Director

Electronic Research Administration

UCI Office of Research

141 Innovation, Suite 250

Irvine, CA 92697-7600

Ph: 949.824.4789 Fax: 949.824.2094

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