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 research. The rule came into effect in 1981, yet no major changes were proposed, until 2011 when the Department of Health and Human Services announced a notice of proposed rulemaking (ANPRM), with a request for comments. Pearl IRB’s White paper addresses the comments and compares the existing rules with some of the changes being considered.  To download a free copy of the White paper, click here.