12/6/2018- 2019 Changes in Human Subjects Research Federal Regulations
January 21, 2019 the federal Office of Human Research Protections will publish the Revised Common Rule (45CFR46). Institutions must implement the new requirements starting January 21, 2019. The University of Louisville Human Subjects Protection Program/Institutional Review Board (HSPP/IRB) has issued a local Policy Addendum addressing how the revisions will be implemented for University of Louisville Research. Major changes include revisions to the informed consent templates, additions to the exempt categories, revised iRIS application, and local Human Subjects and HIPAA Research training requirements for exempt research. All changes must be utilized for studies approved on or after the implementation date. Please review the Policy Addendum for a full list of the changes and how they will be implemented. Information sessions will be announced in January.
IRB Committee Meeting Calendar