Saint Louis University has established three Institutional Review Board (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.
Email email@example.com to join the IRB listserv and receive updates about training opportunities, policy changes and other notifications.
Check here for the latest news and updates from the Institutional Review Board.
The US DHHS and 15 other federal departments and agencies have issued an Interim Final Rule that delays the effective and compliance dates for the New Common Rule by six months, to July 19, 2018. The IRB will continue to use the internal Common Rule Changes Google Site to capture information about forthcoming changes. For now, the IRB and researchers must continue to operate under pre-existing rules.
The IRB has created a Common Rule Changes Site, an internal Google Site with information and updates regarding the forthcoming changes to the Common Rule (federal regulations for human subjects research). While we wait to hear whether the current implementation date of Jan. 19 will be delayed by a year, the IRB is moving forward planning for the changes and will continue to provide the research community with updated information.
The site is located at sites.google.com/slu.edu/common-rule-changes/home. You will need to log into Google Applications to gain access. A link to the Google Site will also be located on the main IRB website.
The White House Office of Management and Budget received a request from the Department of Health and Human Services to consider a one-year delay of the general implementation date of the revised “common rule” (the federal regulations in place for human subjects research), which would change the effective date to January 19, 2019. The request included a consideration to allow institutions’ use of three burden-reducing provisions during the delay year.
The delay request comes as many IRBs have expressed concerns with readiness, and guidance from the federal agencies to assist in implementing the new rule has not materialized. The IRB will provide updates and associated implications to the research community when known.
New to the IRB? The new IRB Sample Protocols Archive, an internal Google site containing examples of approved applications, can be used as a reference when drafting your IRB application.
As of October 1, 2017, NIH-funded human subjects research that began or was ongoing on or after December 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).
Final revisions to the federal regulations covering human subjects research (“the common rule”) were issued by the Department of Health and Human Services on January 18, 2017. The majority of changes take effect on January 19, 2018; single IRB use provisions take effect in 2020. The IRB team will provide additional information, training and policy/procedural change information to the SLU research community throughout the year in preparation for the new rule. Importantly, while numerous federal agencies have agreed to adopt the new rule, the Food and Drug Administration has not.