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. 

6/12/18- Location Changes and the IRB: FAQs

If during the course of the study the physical location of the department or clinic moves, study documents must be revised and subjects must be notified. For further information and frequently asked questions please visit here.

4/1/2018- Fee Schedule and Billing Process Change

The University of Louisville IRB Review Fee Schedule and billing process is changing for industry contracts executed on or after 7/1/18. Please review the revised fee schedule for details on the new amounts and new billing process. Please ensure the updated amounts with F&A are included in contacts/budgets that will be executed 7/1/18 or later.

3/1/2018- Consent Form Changes  

Any approval sent on or after 4/1/18 where consent forms will be stamped will no longer have an expiration date on the stamp. The consent form will be stamped with an approval date only. The consent will expire if the study lapses in IRB approval. Enrollment cannot take place if a study lapses in approval. For additional information view Guide 038.

Biomedical IRB meets for full board meetings on the first, third and fourth Thursday of every month. Social/Behavioral/Educational IRB is scheduled to meet on the first Wednesday of each month.

2019 calendar  - (revised 12/13/2018)