IRB Announcements

2024 IRB Announcements

May 2024

IRB Approval Stamp on Documents for Exempt Studies
Starting July 1,2024, documents will be stamped on new studies deemed exempt following the same guidelines as studies that are approved under expedited or full board review. Stamped versions of the documents are to be used with research participants. For information on what documents are stamped with an IRB approval stamp, click here.

IRB/HSPPO Address Change
The suite number for the HSPPO/IRB has changed to suite 300. The new address is 300 E. Market Street, Suite 300 Louisville, KY 40202. For a note to file outlining the change (e.g. for funded research, FDA 1572 updates, etc), you can access it here.

January 2024

IRB Fees for Industry Sponsored Research with an External IRB of Record
For industry sponsored research contracts executed on or after 07/01/2024, a continuing review administrative fee of $1000 will be billed when relying on an external IRB of record. Details about the updated IRB fee schedule can be found on the IRB Fees webpage.

CITI Program Training-Account Update Needed
A recent ITS update automatically updated all UofL email addresses from userid@louisville.edu to firstname.lastname@louisville.edu across multiple systems. University of Louisville uses the CITI Program website to facilitate a variety of online compliance trainings required by departments at the university (e.g. IRB, IACUC, COI). To ensure that training completion information feeds correctly from CITIprogram.org to UofL systems such as iRIS and Cayuse, please login to CITIprogram.org and update your user profile (top right) to list your firstname.lastname@louisville.edu email address as your primary email address in CITI. Training data merges with other university systems based on this specific email designation. If your current email address in CITI is the userid@louisville.edu iteration of your email, training information will not feed correctly into iRIS. You must update your CITI account information to the correct form of your UofL email address.

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July 2023

Scientific Scholarly Merit Review (SSMR) and/or Department Chair Sign Off
As of July 1, 2023, the HSPPO/IRB has a revised policy manual. Changes include modification to the Scientific Review and Departmental signoff routing in iRIS. This routing for IRB submissions is now only required for studies that are greater than minimal risk (full board studies). Details about this policy change can be found in the IRB Policy Manual. Please reach out to the HSPPO service account at hsppofc@louisville.edu with any questions.


Requesting IRB Led Departmental Trainings
Staff with the Human Subjects Protection Program (HSPP) office, on behalf of both (social/behavioral/educational and biomedical) UofL IRB’s, would be pleased to meet with classes, faculty, staff, residents, and departments to share information about the importance of the research we help facilitate – and how to submit research most successfully. If interested, please complete the training request form.


IRB Research Education Program
The HSPPO and IRB Research Education Program (REP) host ongoing training opportunities covering topics relevant to the UofL research community. You may RSVP for these as they are available, watch recorded sessions, and find information on upcoming sessions.


June 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.

May 2023

Website Update: Answering Stipulations
The HSPP Website has a new Answering Stipulations page. This page offers instructions on the various ways to answer stipulations and upload/revise documents.


Single IRB (sIRB) Review for Multi-Site Federally Funded Research
Federal regulations require a single IRB (sIRB) to serve as the IRB of record for multi-site federally funded (e.g. NIH) research. If you're working on a collaboration that will require sIRB review, and plan for UofL IRB to serve as the sIRB, contact the HSPPO office early in the planning process by completing the Answering sIRB Consultation form. During this consultation, the UofL IRB will review the sIRB request, assist with developing the sIRB, and assist with determining the sIRB fees to include in grants/budgets. More details on external collaborations can be found on the HSPP website.