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Institutional Review Board (IRB)

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 irb@slu.edu or go to the IRB staff page to identify your academic unit’s IRB contact person.

To receive updates about training opportunities, policy changes and other notifications, you can join the IRB Listserv by clicking the link below:

Join the IRB Listserv

News and Updates

Check here for the latest news and updates from the Institutional Review Board.

COVID-19 Research Update - June 29, 2020

As the COVID-19 outbreak continues to change rapidly and we continue to make decisions on how to respond, we want to begin by stating our primary concern is the safety of our research participants, research team members and St. Louis community. We also want to  ensure we preserve the scientific integrity of SLU’s research protocols. We realize the COVID-19 outbreak may cause hardship to SLU’s research infrastructure; however, it is paramount to consider the additional risks now associated with continuing to conduct human subjects research protocols.

At this time the following types of human subjects research is PERMITTED:

  • Research that can be conducted without in-person intervention or interaction with research subjects.
  • Research that explicitly improves or protects the lives of its participants by providing treatment or other medical care. 
  • Research that is directly connected to addressing the COVID-19 crisis. 
  • Research which is limited to procedures which are performed in conjunction with a regularly scheduled visit.

For more information, please refer to the OVPR/SOM Research Resumption Guidelines.

 

New to SLU Research Site

Navigating the SLU research enterprise can be tricky, especially if you're new or you've worked at another research institution. This site attempts to make navigating this process easier and prepare research staff for the necessary levels of oversight needed to conduct human subjects research at SLU.

The site content aims to define the different components that make up the SLU research machine, as well as describe important steps, considerations, and tips for navigating the SLU research enterprise.

Please note: This is an internal site, so you need to be logged into your SLU Google account to access it. You can do this by logging into MySLU or (when prompted after clicking the link) using your MySLU username (called a SLU NetID) followed by @slu.edu and your MySLU password.

Visit the New to SLU Research Site

Open Requests for Comments

This is only the beta version of the New to SLU Research Site. We are seeking your comments and feedback to help improve the site moving forward. Please  submit comments or feedback here.

ClinCard to CCPay Participant Payment Transition

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.

Revised Process - Protocols Involving Non-Standard of Care Radioactive Materials

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. 
Common Rule Changes - Now Effective

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 irb@slu.edu with any questions about this process.

NIH Policy Update: Certificates of Confidentiality

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).


Quick Access

Meeting Dates/Deadlines

Full board meeting dates and deadlines can be found here.

IRB Review Times

COVID-19 Research Update

Our team will get back to you as quickly as possible, but please understand we are prioritizing protocols that directly address the global pandemic.

Depending on the type of review, you should anticipate the following response times:

New Protocols
  • Exempt Review: Notification in two to three weeks
  • Expedited Review: Notification in four to six weeks
  • Full Board Review: Notification within two weeks of IRB meeting date
Amendments
  • Exempt/Expedited Review: Notification in one to two weeks
  • Full Board Review: Notification within a week of IRB meeting date
Forms/Reports
  • Continuing Review Forms: Notification within 30 days of expiry date
  • Report Forms: Varies
  • SAE Reports: Varies
  • Final Report Forms: Notification within a week

Please note: These estimates may vary during times of high volume.

For questions about the status of the review, please contact the IRB Office at 314-977-7744, irb@slu.edu, or visit the IRB staff page for department-specific contact information.

Forms/Guidelines

For your convenience, a compilation of IRB forms and guidelines can be found found here.

Research Investigator Project Planning Checklist

The Research Investigator Project Planning Checklist to can help navigate the different offices responsible for ensuring research safety and compliance regulations are met at SLU.

Sample Protocols Archive

New to the IRB? The IRB Sample Protocols Archive, an internal Google site containing examples of approved applications, can be used as a reference when drafting your IRB application.

Please note: This is an internal site, so you need to be logged into your SLU Google account to access it. You can do this by logging into MySLU or (when prompted after clicking the link) using your MySLU username (called a SLU NetID) followed by @slu.edu and your MySLU password.