1. Institutional Review Board (IRB) 101 Oleg Kisselev, Administrative IRB Chair irb@slu.eduirb@slu.edu, 977-7744 irb@slu.edu *This presentation was prepared/presented in 2.2016. Please visit the SLU IRB website (from SLU homepage: search “IRB”, 1 st result) for the most up-to-date and accurate information.

2. IRB Mission & Purpose Institutional Review Board (IRB): A committee charged with the review of human subjects research to ensure the rights and welfare of human participants are adequately protected and that research is in compliance with federal and state regulations and University policies and procedures.

3. SLU Research Profile Both Biomedical and Behavioral research Both Biomedical and Behavioral research Roughly 700 new protocols each year Roughly 700 new protocols each year –80% minimal risk (meaning 20% or less goes before the board) ~ 900 overall submissions each quarter ~ 900 overall submissions each quarter –Amendments (changes), Continuing Reviews (renewals), safety forms, etc. –Roughly half of those are from “sponsored” studies Studies conducted at SLUH, Cardinal Glennon, SSMSL, St. Mary’s, etc. Studies conducted at SLUH, Cardinal Glennon, SSMSL, St. Mary’s, etc.

4. The SLU IRB & IRB Office IRB Boards (2, 1 ad-hoc) IRB Boards (2, 1 ad-hoc) –Review medical & non-medical research –Each board (2) meets once a month IRB Office IRB Office –Serves the boards & the research community –Coordinators manage submissions by department/academic unit. Check the IRB website for the most up-to-date breakdown Website: http://www.slu.edu/x24634.xml Website: http://www.slu.edu/x24634.xmlhttp://www.slu.edu/x24634.xml

5. Other Levels of Oversight Department/Science Reviews Department/Science Reviews Clinical Trials Office (CTO) Clinical Trials Office (CTO) Radiation Safety (RSC) Radiation Safety (RSC) Institutional Biosafety (IBC) Institutional Biosafety (IBC) Hospital (SSM, SLUH) Review Hospital (SSM, SLUH) Review Pharmacy Review (PTNT) Pharmacy Review (PTNT) Grants, Contracts Grants, Contracts University Administration, General Counsel University Administration, General Counsel

6. Know the SLU IRB Process Which projects require IRB review Which projects require IRB review Mandatory training requirements Mandatory training requirements Which application type to complete Which application type to complete Required information about the research Required information about the research Pre-review signature requirements Pre-review signature requirements Other required compliance approvals Other required compliance approvals Continuing compliance, reporting, and closure requirements Continuing compliance, reporting, and closure requirements Other considerations, processes Other considerations, processes

7. Take Home Points Any human subjects research (HSR) you are starting or bringing with you to start (including chart reviews/existing data sets), must be approved by the IRB before any research activities can start or continue at SLU Any human subjects research (HSR) you are starting or bringing with you to start (including chart reviews/existing data sets), must be approved by the IRB before any research activities can start or continue at SLU Proof of CITI training (www.citiprogram.org)/ comparable HSR training required before IRB submission Proof of CITI training (www.citiprogram.org)/ comparable HSR training required before IRB submissionwww.citiprogram.org Take IRB advice only from IRB staff Take IRB advice only from IRB staff Use IRB resources, know SLU IRB, make a good submission, invest your time Use IRB resources, know SLU IRB, make a good submission, invest your time