Last year the Department of Health and Human Services, along with a number of other federal agencies, announced revisions to regulations surrounding human subjects research (i.e., the Common Rule). The Revised Common Rule (NOT-OD-19-050) is set to go into effect on January 21, 2019 (changed from the previous date of January 19), and applies to all studies initiated on or after this date. Key changes include the following: Modifications to continuing review requirements New categories of studies now excluded from mandatory IRB review Additions and modifications to exemption categories Modifications to informed consent requirements (including the required publication of consent documents on http://www.ClinicalTrials.gov) Introduction of broad consent (though VUMC will not implement at this time) Expansion of single IRB for multi-site research (compliance date: January 19, 2020) Please note that we have updated Coeus to reflect the addition of the two new exemption categories. Furthermore, we would like to clarify that NIH’s upcoming exemption label change (from an ‘E’ to
HHS recently updated the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)” form that is often submitted during JIT for NIH and other federal agencies. Please note this document is used to demonstrate VUMC’s certification of compliance regarding IRB review and approval in accordance with the Common Rule (federal policy for the protection of human subjects). The form can be accessed here, or through OSP’s website, under “Forms.” Please be sure to update your files with the new form.