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Compliance Date for Revised ‘Common Rule’ Policy is Jan. 21

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (usually referred to as the “Common Rule”). The compliance date for the Revised Common Rule is Jan. 21. More>

Any new studies approved on or after January 21, 2019 will be reviewed under the Revised Common Rule regulations.

Existing research that was approved or exempted prior to January 21, 2019 must remain compliant with the old regulations.

To prepare for this change, the Lab’s online system HARP-IRB will be closed to new submissions from January 14-February 1, 2019.

Highlights of the Revised Common Rule include:

– Change in the definition of “research”

– New exempt categories

– Revised informed consent requirements

– Single IRB (the use of one IRB for cooperative research for all non-federally funded research) goes into effect January 20th 2020

Immediate changes that users will see are:

– HARP changes when submitting a new protocol

– Change in the Standard Operating Procedures.

– Informed consent template revision

More information will be provided soon to researchers to understand how the updates to the Common Rule impacts their protocols.

If you have any questions in the meantime, contact the HARC office staff (https://commons.lbl.gov/display/harc/Home).