Beginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB...
On January 18th, the US Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a final rule to revise the federal Policy for the Protection of Human Subjects. The Policy for the Protection of Human subjects, aka the Common...
A Notice of Proposed Rulemaking (NPRM) released 8 Sep 2015 outlines revisions to the Common Rule (45 CFR 46 subpart A) meant to modernize, strengthen, and make it more effective. The most significant changes to the Common Rule proposed in the NPRM are as follows:...
In December 2012, Pearl IRB published a White paper, “What Could Proposed Changes to the Common Rule Mean to Sites, Sponsors and IRBs?” The Common Rule, also known as the Federal Policy for the Protection of Human Subjects outlines regulatory requirements for human...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
