Institutional Review Board (IRB)

A group of research nurses and study coordinators developed a process map of the current clinical trial submission process here at 博彩网址大全. You can access the 博彩网址大全 Clinical Trial Process Map here.

Navigating the 博彩网址大全 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 博彩网址大全.

The site content defines the components that make up the 博彩网址大全 research machine, and describes important steps, considerations, and tips for navigating the 博彩网址大全 research enterprise.

Please note: This site is internal, so you must log in to your 博彩网址大全 Google account to access it. You can do this by logging into My博彩网址大全 or (when prompted after clicking the link) using your My博彩网址大全 username (called a 博彩网址大全 NetID) followed by @ejly.net and your My博彩网址大全 password.

Visit the New to 博彩网址大全 Research Site

Open Requests for Comments

This is only the beta version of the New to 博彩网址大全 Research Site. We seek your comments and feedback to help improve the site moving forward. Please submit comments or feedback here.

As 博彩网址大全 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’s Terms and Conditions.

If a study is still enrolling and is approved by the 博彩网址大全 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 博彩网址大全-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: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.

What Do Researchers Need to Know?

The 博彩网址大全 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 博彩网址大全 Google Applications to gain access. 

Please contact irb@ejly.net 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).

• 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@ejly.net, 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 博彩网址大全.

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 博彩网址大全 Google account to access it. You can do this by logging into My博彩网址大全 or (when prompted after clicking the link) using your My博彩网址大全 username (called a 博彩网址大全 NetID) followed by @ejly.net and your My博彩网址大全 password.