Saint Louis University (SLU) strives to conduct research of the highest quality and integrity. The Institutional Review Board (IRB) supports this goal by ensuring that all SLU research involving humans is conducted in accordance with the regulations, laws and policies in place to protect the rights and welfare of human research volunteers.
SLU has established three IRB committees, supported by an administrative team in the Research Integrity and Safety Group within the Office of the Vice President for Research, to review and oversee human research studies conducted at SLU or by SLU researchers.
Researchers are assumed to need SLU IRB approval if they are conducting human research unless the use of a Central or External IRB has been approved. The IRB team supports SLU researchers with the IRB process requirements, and through our education and quality assurance programs. If you need the IRB team’s help, call 314-977-7744, email firstname.lastname@example.org or go to the IRB Staff page to identify your academic unit’s IRB contact person.
Email email@example.com to join the IRB listserv and receive updates about training opportunities, policy changes and other notifications.
News and Updates
Check here for the latest news and updates from the Institutional Review Board.
As SLU is currently in the process of transitioning from the use of ClinCard to CCPay for study participant payments, the informed consent template now includes revised payment language to generalize the card type and vendor name.
For previously approved informed consent documents that specify the use of ClinCard, if transitioning to CCPay, the IRB is providing an informational memo to be discussed and given to the participant to serve as notification of the change. Please note: participant signature is not required for the memo.
Researchers should provide participants with both the informational memo and CCPay’s Terms and Conditions.
If a study is still enrolling and is approved by the SLU IRB, study teams may want to consider updating the informed consent language to generalize the card type and vendor name at the time of the next Amendment or Continuing Review submission. For existing central IRB studies, to prevent fees for SLU initiated changes, the informed consent language does not need to be revised.
Effective immediately, protocols that involve non-standard of care radioactive materials and will require review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC) have a streamlined submission process. The IRB has revised the SLU IRB Radiation Safety Guidance to reflect these key changes:
- Previously the RSO/RSC review had to occur before IRB submission. The streamlined process now allows for concurrent review. However, studies using a central IRB should still submit to the SLU RSO/RSC before central IRB submission.
- The proposed radiation risk language will either be drafted by IRB staff or drafted by the research team and then verified by IRB staff at the time of IRB submission.
- In some cases a study sponsor may require review of the proposed informed consent, including radiation risk language, prior to IRB submission. IRB staff will assist with drafting the appropriate language. Contact your IRB Analyst for assistance.
- As noted in the informed consent template, the radiation risk language statements have been simplified and shortened.
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have made revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule), effective January 21, 2019. These revisions are an effort to modernize, simplify and enhance the current system of oversight. The Final Rule and additional related information can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.
What do researchers need to know?
The SLU IRB has created a Common Rule Changes Site, an internal Google Site with information and updates regarding the forthcoming changes to the Common Rule. Guidance documents and other resources released by the IRB will be stored on the Release Tracking page of the site to allow researchers to quickly locate released items, associated release notes, and other helpful information.
The site is available through Google Sites. You will need to log into SLU Google Applications to gain access.
Please contact firstname.lastname@example.org with any questions about this process.
As of Oct. 1, 2017, NIH-funded human subjects research that began or was ongoing on or after Dec. 13, 2016 is now covered by a Certificate of Confidentiality, which requires specific language to be present in the study consent form.
Contact the IRB for assistance if your study needs to comply with this new policy (NOT-OD-17-109).