Institutional Review Board (IRB)
麻豆视频下载 strives to conduct research of the highest quality and integrity. The Institutional Review Board (IRB) supports this goal by ensuring that all 麻豆视频下载 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.
麻豆视频下载 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 麻豆视频下载 or by 麻豆视频下载 researchers.
Researchers are assumed to need 麻豆视频下载 IRB approval if they are conducting human research unless the use of a central or external IRB has been approved. The IRB team supports 麻豆视频下载 researchers with the IRB process requirements, and through our education and quality assurance programs. If you need the IRB team鈥檚 help, call 314-977-7744, email irb@slu.edu or go to the IRB staff page to identify your academic unit鈥檚 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:
To receive the 麻豆视频下载 Research Biweekly Update, click the link below:
News and Updates
Check here for the latest news and updates from the Institutional Review Board.
A group of research nurses and study coordinators developed a process map of the current clinical trial submission process here at 麻豆视频下载. You can access the 麻豆视频下载 Clinical Trial Process Map here.
Navigating the 麻豆视频下载 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 麻豆视频下载.
The site content defines the components that make up the 麻豆视频下载 research machine, and describes important steps, considerations, and tips for navigating the 麻豆视频下载 research enterprise.
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Open Requests for Comments
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As 麻豆视频下载 transitions from using 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鈥檚 Terms and Conditions.
If a study is still enrolling and is approved by the 麻豆视频下载 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 麻豆视频下载-initiated changes, the informed consent language does not need to be revised.
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have revised 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 oversight system. The Final Rule and additional related information can be accessed at: .
What Do Researchers Need to Know?
The 麻豆视频下载 IRB has created a , 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 . You will need to log into 麻豆视频下载 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 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 麻豆视频下载.
New to the IRB? The , 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 麻豆视频下载 Google account to
access it. You can do this by logging into My麻豆视频下载 or (when prompted after clicking
the link) using your My麻豆视频下载 username (called a 麻豆视频下载 NetID) followed by @slu.edu and
your My麻豆视频下载 password.