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.

IRB Committee Meeting Calendar

2019 IRB Committee Calendar  - (revised 12/13/2018)

HSPPO Education Series

Wednesday 05/29/2019 12:00p-1:00pm

New Clinical Research Billing Compliance Review Information Session

Allyson Turner and Serra Bayraktar are hosting an education session on the new billing compliance review process for clinical research. Beginning July 1, 2019, all new clinical research contracts and contract budget amendments submitted to the Clinical Contracts Division (CCD) will go through a Research Billing Compliance review and approval process. This education session will provide important information for departments navigating the new process.  Individuals who develop clinical research budgets and informed consents are encouraged to attend. Presenters will go over the billing compliance review steps, discuss the impact on the timeline and will hold a Q&A session. 

RSVP at https://www.surveymonkey.com/r/ULRSVP