IRB UPDATES

Changes Governing Human Subject Research (Common Rule)
- as of June 18 (publish date expected June 19, 2018), implementation and effective date delayed to January 21, 2019

Single IRB Updates
-NIH rule remains in effect, with implementation date of January 25

Welcome Message

Welcome to the website of the BSD/UCMC Institutional Review Boards at the University of Chicago.  At this site you will be able to access the IRB online submission system, AURA, as well as guidance and links to other helpful sites and resources.

The BSD/UCMC IRBs are charged with the responsibility for review, approval and surveillance of all research involving human subjects carried out in the BSD and the University of Chicago Medical Center.  This review and surveillance is conducted to assure the protection of the rights and welfare of all research subjects, including volunteers and patients, as well as ensure compliance with regulations.

We encourage you to contact us with any questions.

 

NEWS FROM THE IRB OFFICE

3/26/2018 The main workspace in AURA-IRB has been redesigned and minor changes made to the new protocol submission form. See email to the research community for more details on this change. Email re: AURA update
3/21/2018 An updated Policies and Procedures Manual has been posted. Revisions include (1) New policy on DOD-regulated research (2) Revised guidance on use of coded biological specimens (more restrictive definition for research that is not subject to IRB review)
(3) Re-ordered sections to group related items and renamed sections to reflect new groupings, other editorial changes (4) Removed guidance that is duplicated by information on the IRB website (5) Added existing policy on use of proxy consent
(6) Clarified IRB responsibility for HIPAA review. Please see the Policies & Procedures page for the updated manual.
Email re: February 2018 P & P updates
12/27/2017 The IRB consent/authorization form template has been revised to reflect the revised Common Rule regulations, most notably the requirement for a concised and focused presentation of key information at the beginning of the consent form. Please see the Forms & Guidelines page for the updated version. Email re: January 2018 IRB updates
10/3/2017 An updated Policies and Procedures Manual has been posted. Revisions include (1) Revised section V (Informed Consent) (2) Revised language on quorum requirements and expedited reviewers (3) Clarification on tabling and (4) Updated IRB address. Please see the Policies & Procedures page for the updated manual. Email re: August 2017 P & P updates
6/30/2017 The IRB consent/authorization form template has been revised to reflect the new OCR/IRB address. The new template version is dated July 2017. Please see the Forms & Guidelines page for the updated version. Email re: July CF template
4/4/2017 An updated Policies and Procedures Manual has been posted. Additions include (1) revisions to the central IRB review policy and (2) removal of suggested consent form language. Please see the Policies & Procedures page for the updated manual. Email re: January 2017 P & P updates
11/2/2016

The new submission smartform in AURA-IRB has been redesigned in order to streamline the form and take advantage of system functionalities. AURA-IRB will be offline Thursday, Nov. 3 from 6-9 PM in order to implement this change. Beginning November 4, any new protocol submission started in AURA-IRB will use the new submission form. See email to the research community for more details on this change.

Email re: AURA update
10/31/2016

The IRB consent/authorization form template has been revised to include OCR changes to the "What are the costs?" section. The new template version is dated October 2016. Please see the Forms & Guidelines page for the updated version.

Email re: October CF template

Email attachment with Specific Cost section change

12/21/2015 The IRB consent/authorization form template has been revised to include OCR changes to the "What are the costs?" section. The new template version is dated December 2015. Please see the Forms & Guidelines page for the updated version.

Email re: December 2015 CF template

Email attachment with Specific Cost section change

12/4/2015 An updated Policies and Procedures Manual has been posted. Additions include (1) information on the UCM Quality Committee (2) language concerning enrolled minors and providing consent to continued participation in a study upon reaching age 18 (3) employees and students as research participants (4) new subsection “Genetic Analysis” incorporates consent form guidance typically provided by IRB office (5) clarify role of Pathology Biospecimen Utilization Committee (PBUC) (6) editorial changes. Please see the Policies & Procedures page for the updated manual. Email re: September 2015 P & P updates
8/28/2014 An updated Policies and Procedures Manual has been posted. Changes are editorial. Please see the Policies & Procedures page for the updated manual. Email re: August 2014 P & P updates
7/8/2014 An updated subject consent/ authorization form template has been posted. Please see the Forms page for the updated template. Email re: July 2014 template update
4/22/2014 An updated Policies and Procedures Manual has been posted. Changes include the addition of citations of relevant FDA regulations. Please see the Policies & Procedures page for the updated manual. Email re: April 2014 P & P updates
11/22/2013 Continuing review deadlines have been updated to fall closer to study expiration dates. Deadlines are posted on the Meeting Dates page. Please see communication to researchers sent via email on 11/22/13 for more information. Email to research community re: CR deadlines
11/21/2013 An updated Policies and Procedures Manual has been posted. Changes include revised guidance on PI eligibility and use of short form consent forms. Please see the Policies & Procedures page for the updated manual. Email re: November 2013 P & P updates
9/25/2013 An updated Policies and Procedures Manual has been posted. Changes include new guidance on timing of signatures on consent forms. Please see the Policies & Procedures page for the updated manual. Email re: September 2013 P&P updates
7/2/2013 The IRB practice regarding approval dates of renewals and amendments has recently been updated. Please see attached memo and share with sponsors, if needed. Updated memo re: approval dates
1/28/2013 The IRB practice regarding approval dates of renewals has recently been updated with the conversion to AURA. Please see attached memo and share with sponsors, if needed. Memo re: approval dates
4/2/2012 The IRB practice regarding stamping of consent forms has recently been updated with the conversion to AURA. Please see attached memo and share with sponsors, if needed. Memo re: consent form stamping
3/9/2012 An updated Policies and Procedures Manual has been posted. Changes are mainly administrative, including standardizing naming conventions for UCMC and updating regulatory and Divisional policy references. Please see the Policies & Procedures page for the updated manual.  
4/2/2012 The integrated Grants/IRB University-wide electronic research management system, AURA, has been implemented for IRB submissions as of April 2, 2012. Updates on the IRB conversion process from IRBWise to AURA will be sent to the research community when available. Please also check the Training page for information on training sessions. OCR Communication regarding AURA transition sent 1/24/12: AURA announcement
2012 Please see the FWA page for more information on the University of Chicago FWA and its updated expiration date.  
October 2011

The BSD/UCMC IRB consent form template has been updated to include new FDA-mandated language regarding clinical trials. In addition, the template now includes the name change from "University of Chicago Hospitals" to "University of Chicago Medical Center." Please use the updated template, dated October 2011, available on the Forms & Guidelines page.

 
7/1/2009 Unanticipated Problem Reporting Policy replaces the AE and Deviation Reporting Policies effective July 1, 2009. Click here for more information.  
May 2009 Concurrent routing documents are required for NEW protocols beginning May 2009. An email was sent to all faculty in February 2009 with this information. Please see the OCR website and here for more information.  
7/14/09 New rules for OHRP/FDA registration of IRBs are in effect as of July 14, 2009. The BSD IRBs have registered as required. This information is publicly available on the OHRP website and on the FWA page of this website. If you require more information, please contact the IRB staff.  
6/26/09 Guidance on reporting conflicts of interest posted. Email from IRB chair dated 6/26/09
3/3/09 Effective 3/3/09, signature of the IRB Chair or Vice Chair will no longer be included on IRB status determination letters. Please see the letter from the Chair of the IRB (linked below) for details on this change to approval, pending-conditional, and other types of official IRB status determination letters. Policy change: IRB letters