IRB Announcements

6/30/2023 Policy and IRB Consent Template Updates 

On July 1, 2023, the HSPPO will post a revised policy manual and summary of changes on the HSPPO website. Noteworthy changes include, revisions to the scientific merit and department chair signoff process and changes to the review processes for case reports. For more details on the upcoming changes, click here. Updated consent form templates will also be available on July 1. For new submissions to the IRB, please use the latest templates available. 

Updated consent form templates will be available July 1. For new submissions to the IRB, please use the latest templates available. The updated consent templates now have the investigator signature line as an optional item. If the investigator signature line is included on consent forms, it must be signed within 14 days. Requests to remove the investigator signature line on consents for existing studies must be submitted to the IRB for review and approval. This can be submitted as an amendment or as the only allowed consent modification on a continuation review.

6/25/2021 iRIS Upgrade Maintenance and Information 

iRIS will undergo upgrade maintenance on Friday, June 25, 2021 from 5:30pm - 9:00pm . During this time, there may be multiple system restarts, so we encourage everyone to save their work before 5:30pm and remain out of the system during this time. For information on iRIS IRB Module changes and IRB Application changes, please review:

June 2021 iRIS IRB Module Changes

June 2021 iRIS IRB Application Changes

4/5/2021 HSPPO has a new office location!

The HSPPO/IRB has moved to a new location. Our address is now 300 E. Market Street, Suite 380, Louisville, KY 40202. If you need a note to file outlining the change in address (e.g. funded research, FDA 1572 updates, etc), you can access it here.

Update 3/2/2021 iRIS IRB Form Issue

On Thursday 2/25/21 a system wide issue with iRIS was identified—an old version of the COI form was pulling into every form across iRIS. As of Tuesday 3/2/21, it appears the vendor has addressed the issue. You can proceed with creating forms in iRIS and submitting to the IRB.

You may see COI information in a form if you started it between 2/25/21 and 3/1/21. If you encounter any COI sections showing in IRB forms, do not submit it. Please create a new version of the form for submission. The COI information should not show up on new forms started today.

If you discover any forms still pulling COI information, please email kristyn.singleton@louisville.edu so we can investigate.

7/1/2020 New consent, assent, preamble, and HIPAA waiver templates available

The changes in the versions include new conflict of interest language, removing sites from the HIPAA waiver and minor administrative updates. Please pull templates from HSPPO website when starting a new initial submission to ensure the most recent templates is utilized. 

7/1/2020 Initial Submission tab updated on HSPPO website

The Initial Submission tab on the HSPPO homepage has been updated to include step by step instructions for submitting a new study to the IRB. The goal is to help researchers navigate the IRB submission process more efficiently.

5/1/2020 Summary of Changes Document Now Needed for Investigator Initiated Research 

UofL IRB will require researchers to include a “protocol summary of changes document” on protocol amendments for investigator initiated studies. This document will outline the changes made in the revised protocol that is being submitted for review. This document will continue to be updated as protocol amendments occur, making it easy to summarize the changes occurring over the life of the study. This does not replace the requirement to submit a “tracked copy" of the revised protocol.

Protocol Summary of Changes Template can be found at https://louisville.edu/research/humansubjects/qip/qip

02/21/2020 Study Location/Name Changes and the IRB: FAQs

During the course of a study, if the location or name of the study site changes, study documents must be revised and subjects must be notified. For further information and frequently asked questions please visit here.

01/01/2020 Revised HSPPO Policy Manual

The HSPPO/IRB office updated the HSPPO Policy Manual along with some of the IRB document templates. The revised policy manual went into effect 1/1/2020 and is available on the HSPPO website along with a summary of changes. Revised templates should be used on new submissions to the IRB. 

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. 

6/12/2018 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.