Working with the IRB

1. 1 Working with the IRB Emory University IRB Sarah Putney, JD CIP February 26, 2008

2. 2 Overview Dual nature of IRBs Looking backward Looking at today and tomorrow Three key domains: People Systems Time Your questions welcome!

3. 3 Dual Nature of IRBs Theory, ethical principles, rules, guidance Peer review/jury of peers Intellectual Balanced Good science meets good ethics Practical execution Production line Personnel Systems (including communications) Culture

4. 4 Dual Nature Challenges are to get it right (as best as we can, given the principles, rules, expertise, analysis, etc.) Integrating theory and practice Responding to new kinds of science, risks, and exposures Staying focused Efficiently Positively Adding value

5. 5 Looking Backward Emory’s IRB struggled to make the transition that marked the past decade across the country’s academic research centers From “homespun” model of Faculty Chair and parttime secretary being the IRB admin. From SOM ownership To 23-member staff with professional leadership and career potential To 7 committees To University ownership Many system failures Traumatization

6. 6 Time for a change Summer 2007 – transition peak Fall 2007 – “New IRB” gets going Site Visit by AAHRPP (accrediting body) 2008 – New IRB takes root and moves forward Accreditation by AAHRPP anticipated Measurable QI initiatives New education and outreach

7. 7 Looking at Today… IO with much IRB experience (University) Commitment from top down for improvement Revisiting policies and procedures Revising in batches Balancing historical culture and need for improvements New staff Active professional development New Edu & QA Consultants

8. 8 …Today… Still not quite fully staffed or trained but getting there App. 4500 active studies 7 committees: Biomedical - 6 Social-Behavior – 1

9. 9 …and Tomorrow Revamping e-IRB Increased knowledge and skill of staff, IRB members, and leadership Faster turnarounds Better customer service (communications, timeliness, accuracy, quality of advice, etc.) Low frustration level

10. 10 Domain 1: People Essential training for you CITI biomedical (add modules as appropriate) E-IRB class with Christine Gomez (cgomez@emory.edu; schedule at www.emory.edu/irb) HIPAA Privacy Rule and Security Rule training (by Office for Research Compliance – see www.emory.edu/orc) Experience (bring your sense of humor, patience, and best communication skills)

11. 11 Essential Approaches Ask questions by tel, email, or in person Come to Helpdesk on Fridays 11-1 Make an appointment to discuss with staff Please avoid dropping in if possible so we can be prepared and productive with your time Get to know your IRB staff analysts Try to understand their pressures Communicate but try not to obsess Be nice – it will pay off!

12. 12 Systems: eIRB/eResearch Get your training ASAP Expect glitches and frustrations Know that IRB staff and members feel it too We are actively working on improving in short and long term To date, Emory is invested in Clickcommerce We are advocating for better IT staffing for eresearch revisions We want to be collegial partners not obstacles

13. 13 Systems: Paper May not affect you All new studies are in eIRB Migration will continue through much of 2008 BUT: keep your own paper records of eIRB studies in good order! Privacy Confidentiality Data security/staff training

14. 14 Systems: Review Processes Set up your eIRB account, get permissions IRB Staff do an initial review Ask for more info Ask questions to ensure clarity and completeness Are not perfect Cannot catch everything at once May ask several rounds (please be patient) Staff forward to primary and secondary reviewers (IRB members)

15. 15 Systems: Review Processes Staff TRIAGE: Is it “research” with “human subjects”? If it is, is it exempt? If it is nonexempt, is it eligible for expedited review? Which regulations does it invoke? HIPAA Privacy Rule FDA, VA, OHRP regulations Special rules for vulnerable populations

16. 16 Not Human Subjects Research Good news for everyone! No further review needed No need for HIPAA pt. authorization/waiver if not “human subjects” Best practice: ask IRB to determine Trained to interpret rules and guidance Researcher can determine, at own peril Journals may refuse to publish if you got it wrong

17. 17 Exempt Research More good news for everyone! BUT…some things must be cleared, so submission in eIRB required Informed consent must be appropriate PI cannot make determination HIPAA Privacy Rule may still apply (may need patient authorization or waiver) Exempt determinations can be made by qualified IRB staff and members Cannot be done retroactively!

18. 18 Essential Approaches Understand that we try to comply with rules SENSIBLY but sometimes have no wiggle room Understand the Committee members have a job to do Minimize risks to subjects Make sure we are all complying with abundant rules Science is solid Maximize benefit, ease and convenience for subjects

19. 19 Systems: Review Processes Once staff think it is ready, forward study to members as primary, secondary, tertiary reviewers Reviewers analyze, ask more Qs to PI (via staff “Owner”) PI responds Study is put on an agenda if not eligible for expedited review Members receive notice to review pre-meeting You can ask to attend or be called during meeting to answer Qs Meeting: review, discussion, vote Defer Pending Approval Approve Table Disappove

20. 20 Systems: Review Processes Post-meeting followup: in e-IRB, PI gets letter notice of IRB action PI needs to respond to questions or submit revisions Chair/Vice Chair/designated member reviews responsive material and finalizes approval Staff send validated materials, notice letter etc to PI via eIRB PLEASE: do NOT start HSR activities before getting your final approval in hand! Exception: physicians should treat patients

21. 21 Systems: Expeditable Same thing except no meeting One or more qualified members review and one approves Staff followup as for full board via eIRB

22. 22 Time IRB is working on improving turnarounds but still has a long way to go Give as much lead time as you can Good review takes time Ask questions about our forms & rules so you submit clear, pertinent information Let IRB know of real deadlines and exigencies Follow up as needed to track progress Please be nice

23. 23 Time IRB’s constraints on deferrals From the federal DHHS and FDA regulations Deferral v. Pending? Deferral is appropriate when complex, substantive information is missing and/or information bearing on seven regulatory criteria for approval Pending Approval is appropriate when the IRB can request specific minor revisions; some confusion over “simple concurrence”

24. 24 Time What turnaround can you expect? Here are AVERAGES (vary according to quality of submissions, staffing, novel issues, COIs, etc.) Full board: app. 6-8 weeks til IRB meeting Amendments: 3 weeks til IRB meeting Continuing reviews: before expiration if possible Expedited: app. 2-8 weeks Amendments: 2-4 weeks Not HSR or Exempt: 2-4 weeks

25. 25 Emory IRBContact Information Located at 1599 Clifton Rd., 5th floor, Decatur GA 30022 (404) 712-0720 (Telephone tree) Email irb@emory.edu www.emory.edu/irb Staff member contact information (best bet) E-IRB portal Practical guidance, forms, etc. Note: new website coming soon!

26. 26 Q&A Thank you! Sarah Putney, JD CIP IRB Director Emory University sputney@emory.edu – EMAIL IS BEST (404) 712-9750 Assistants: Julia Myles or Judy Phillips (404) 712-0750