Major changes to the Common Rule (45 CFR 46 subpart A) are expected to become effective January 19, 2018. IRBMED will approve Amendments and Continuing Review submissions according to 2018 Common Rule after the Effective Date, thus “transitioning” ongoing approved studies to the new regulations. Some studies are likely to be subject to a small number of added requirements. A new question in the eResearch “Amendment Cover Sheet” (aka “Edit Amendment Forms”) will identify these studies; a “transitional form” included with the Amendment will document how the study will satisfy applicable approval criteria. IRBMED staff will also encourage a “transition” Amendment at the time of Continuing Review for studies that appear likely to be subject to new requirements.
Click here for more information about the transition to 2018 regulations.
Common Rule changes include new informed consent requirements. To assist researchers in meeting these requirements in their existing, IRB-approved consent documents, IRBMED has developed a supplemental text designed to satisfy all new consent requirements. These new requirements include:
a brief introductory overview of the study, highlighting key information about study participation
new required elements of informed consent
Click here for more information about new informed consent requirements and how to use the supplemental text box.