### INSPIR: Revolutionizing IRB Protocol Submission and Tracking ###

1. Introduction to INSPIR OCR Seminar Series January 21, 2004 Mary Banks, RN Administrator, Office of the IRB

2. “The Future Is Now”Yogi Berra

3. What is INSPIR ? Integrated Network for Subject Protection In Research

4. INSPIR Background • Developed as BRAIN at Baylor School of Medicine • Currently used at Baylor and University of Maryland (BRAAN) • Result of IRB Improvement Grant (NIH) • Customized to fit Boston University requirements • Will be used at BUMC and Charles River Campus • Used by BUMC IRB and IACUC

5. System Requirements • January Issue of CR Times (www.bu.edu/crtimes)- link • Connecting to INSPIR • Browser • Macintosh, Netscape version 7 • Safari for Mac • PC- Internet Explorer 6.0 or higher • Cookies must be enabled • Pop-up Blockers must be disabled www.bumc.bu.edu/Departments/PageMain.asp?Page=8725&DepartmentID=368

6. Useful Tip • Attachments (drug brochures, sponsor’s protocol, grant applications) will have to be scanned and “attached” to the IRB application • Extremely helpful if you have a scanner within the department to use to scan these documents

7. Access to INSPIR • Website “Getting Access” • Presence in BU’s electronic directory • BU Login Name, BUID Number, and Kerberos password • If you don’t have a presence in BU’s directory (BMC, VA) instructions available • Do this now- don’t wait www.bumc.bu.edu/Departments/PageMain.asp?Page=8636&DepartmentID=368

8. Difficulties Logging Into INSPIR • Login issues and technical issues will NOT be managed by the IRB office • Contact the IT INSPIR Team at BRAAN@bu.edu • Helpful advice on website under “Help!” www.bumc.bu.edu/Departments/PageMain.asp?Page=8094&DepartmentID=368

9. What Does INSPIR Do? • Allows for IRB protocols to be created, routed, reviewed, signed, and approved within the system • Provides for transparent processing- everyone who has access can see where the protocol is at each step in the process • Creates IRB meeting agendas and minutes • Gives reviewers and investigators access to the entire study file (including previous versions that are archived in the system) • Automatically generates continuing review reminders

10. Why Be INSPIRed? • Electronic submission of protocols • No longer need to submit multiple copies to IRB • Not rely on interdepartmental mail • No need to hand deliver documents to the IRB office • Documents won’t get lost • Accurate study files- investigator files will match IRB files

11. Why Be INSPIRed? (cont.) • Investigators can track the progress of own protocols • Multiple copies of documents (approval letters, consent forms, etc.) with version control can be printed • Applications are automatically routed for required signatures • Continuing Review process is much easier because amendments, SAEs, etc. are cumulatively tracked • Investigators can access INSPIR from any internet connected computer

13. 2004 summer April Jan Feb Mar May Mar. 8 IRB office Stops Accepting Paper Mar. 15 GO LIVE 3/8 - 3/15 IRB office CLOSED 2/23 - 3/15 Train the Investigators

14. Important Dates for Investigators and Research Staff at BUMC • February 23 - March 15 Investigator training • March 8 IRB Office stops accepting paper submissions • March 8 - 15 IRB Office closed • March 15 Go Live Date

15. Investigator Training • Feb. 23 - Mar.15 • Training will include • Online training • Investigator Manual • Large group classes • Small group classes • Schedule of classes will be posted • Practice site will be available for investigators to use

16. IRB Office Stops Accepting Paper • March 8, 2004 • All paper Progress Reports must be submitted by this date • Can submit Progress Reports for March, April and May • Last date to accept new Research Applications in paper • Last date to accept amendments in paper

17. IRB OFFICE CLOSED • March 8-15 • No paper or electronic submissions accepted during this week • Investigator training will be ongoing during the week • IRB office staff will be available for training and to answer questions

18. GO LIVE • March 15, 2004 • First day protocols can be submitted electronically • New protocols • Progress Reports (Continuing Reviews) • Amendments

19. New IRB Applications • Full Board, Expedited and Exempt • Submit on paper by March 8 OR • Must hold and submit on or after March 15 electronically • Investigators can work on drafts prior to March 15

20. Continuing Review • Progress Reports must be submitted by March 8 on paper OR • Must be held until March 15 for submission electronically • Investigators may submit on paper for March, April, May only • Studies that expire after May 31, 2004 – Progress Reports must be submitted electronically

21. Continuing Review • After March 8 all Progress Reports (CRs) must be submitted electronically • To submit a Progress Report the investigator must first enter the study into the system using a new application

22. Continuing Review • If PI submits a new protocol on March 8 on paper - will have to re-submit the study electronically at time of next Continuing Review • Investigators must ensure that studies will not lapse • Progress Reports must still be submitted at least 5 weeks prior to expiration

23. Amendments • After March 8 all amendments must be submitted electronically • Prior to submitting an amendment the investigator must enter the protocol into the system (by completing a Research Application for the study)

24. Serious Adverse Events • March 8 deadline does not apply to SAEs • SAEs may be submitted on paper until the study is up for Continuing Review (or an amendment is needed) • More information on SAEs will be coming - the IRB is modifying the policy on submitting SAEs to the IRB

25. Demonstration of INSPIR • Demonstration site (practice site) will be available soon for use by investigators • Final modifications being made to the system • We will provide investigators paper copies of screen shots • We will provide an electronic Investigator’s manual

26. Go To Demo