Institutional Review Board (IRB)

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 

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).

• 2021 IRB Meeting Dates/Deadlines

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.