Saint Louis University 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 notifications about news and updates, policy changes, training opportunities,
and other pertinent information, you can join the IRB Listserv by clicking the link
below:
Subscribe to the IRB Mailing List
To receive the SLU Research Biweekly Update, click the link below:
Subscribe to the SLU Research Biweekly Update
COVID-19 FAQs & Resources
As the COVID-19 pandemic expands and the situation continues to evolve, the SLU IRB
is working closely with University officials and the Office of the Vice President
for Research to establish guidance for human research operations. This guidance is
intended to help the research community limit the potential risks and impact to active
research studies as they relate to COVID-19.
In light of the broad vaccine availability, SLU has begun to plan for a fall semester
where we are back to operating largely face-to-face. On June 8, 2021, a new COVID-19
vaccination requirement was announced requiring all Saint Louis University students,
staff, and faculty to be fully vaccinated against COVID-19. This direction was validated
with new guidance released from the Centers for Disease Control and Prevention (CDC),
which states that institutes of higher education where all faculty, staff and students
are fully vaccinated can return to a normal, full-capacity operation.
Currently, there are no longer any categorical restrictions on the types of human
subjects research studies which may proceed.
However, to the extent possible, human research activities should continue to be conducted
remotely. This includes the following (as long the value or integrity of the research
study is not reduced): consenting, conducting interviews/questionnaires, data analysis,
manuscript preparation, etc.
In addition, investigators with new or existing studies are still expected to develop
rigorous research transition and monitoring plans to ensure the safety of research
participants, research personnel, and others during the remainder of the COVID-19
pandemic. With these plans, investigators should ensure the risks associated with
conducting each study will be continuously monitored and evaluated throughout the
remainder of the COVID-19 pandemic and ensure the plan will be modified as needed
to continue to minimize the risks to research personnel and participants. These plans
are subject to school/department review and approval; however, they no longer need
to be reviewed and approved by the IRB Office prior to study initiation or re-initiation.
However, the IRB may wish to review the research transition and monitoring plans for
adequacy on a case-by-case basis, in which case a detailed plan must be made available
to the IRB upon request.
Investigators are also expected to follow all applicable guidelines and safeguards
put in place by Saint Louis University at its various locations, including but not
limited to the SLUCare and SSM Health Guidelines for Clinical Care. In addition, investigators
are expected to follow any guidelines and safeguards in place at individual locations
should the research occur off-campus. Investigators are also expected to follow OHRP,
FDA, CDC and other federal guidelines relating to the COVID-19 pandemic. In the event
a study requires a deviation from the applicable guidelines and safeguards, the research
transition and monitoring plan should address the deviation(s) with adequate justification
and describe the alternative safeguards put in place (i.e., a study which requires
the investigator observe facial expressions of the participant without a mask).
IRB staff members are working remotely and IRB meetings are being held virtually. While
some of the IRB Staff has been working on campus part-time, in line with SLU’s return-to-campus
expectations, all SLU IRB Staff will return to campus full-time on August 2, 2021. RB
Analyts are still happy to arrange Zoom meetings or conference calls with researchers
as needed.
The main phone line (314-977-7744) is continuing to be monitored during the weekdays.
You may also reach out to our office at irb@slu.edu for additional help.
Please note: We have moved to a new location: Schwitalla Hall, Suite M238. Please feel free to
stop by (and don’t forget to update your study’s FDA Form 1572 and other applicable
regulatory forms with our new mailing address).
SLU Resources
- SLU COVID-19 Coronavirus Updates
- SLU Guidelines and Safeguards for on-campus activities
- SLU OVPR COVID-19 Research
- SLU OVPR Human Subjects Research Resumption Guidelines
- SLUCare and/or SSM Health Guidelines for Clinical Care (accessible only to SLUCare/SSM Health personnel)
Federal Resources
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency | FDA.gov
- FDA Guidance on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry | FDA.gov
- NIH Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 | NIH.gov
- OHRP Guidance on Coronavirus | HHS.gov
Additional Resources
- American Medical Association (AMA) COVID-19 Ethics Resource Center | AMA.org
- Ampersand COVID-19: Updates for the Oversight Community | PRIM&R.org
- Association of Clinical Research Professionals (ACRP) COVID-19 News & Resource Center | ACRP.net
- Association of Clinical Research Organizations (ACRO) COVID-19 Resource Center | ACRO.org
- CITI Coronavirus (COVID-19) Resources | CITIProgram.org
- HRP COVID-19 Helpful Information | HRPConsultingGroup.com
Central IRB Resources
- Advarra Coronavirus Guidance | Advarra.com
- WIRB Resource Center: COVID-19 and Clinical Trial Operations | WCG.com
News and Updates
Check here for the latest news and updates from the Institutional Review Board.
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.
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 irb@slu.edu 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).
Quick Access
The time to process an application depends on the complexity of the research study
and the quality and completeness of the application submitted. Other variables include
whether the application can be approved by the IRB Chair or Designee (exempt/expedited
review) or by the full board.
*Please note: Estimated review times may vary during times of high volume.
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
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.
For your convenience, a compilation of IRB forms and guidelines can be found found here.
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.
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.