1. AAHRPP Association for the Accreditation of Human Research Protection Programs Thanks to: Lisa Demanuel, Program Specialist Brain Rehabilitation Research Center VA RR&D Center of Excellence

2. Human Research Protection Program (HRPP) An institution’s unique system to safeguard human subjects.

3. HRPP Responsibilities Protection of Human Subjects Protection of Human Subjects Protection of Human Subjects

4. Who is responsible for the HRPP? Director –Thomas A. Cappello MPH, FACHE −Responsible for the R&D program of the institution, advised and assisted by an R&D Committee −Responsible for HRPP of institution Chief of Staff-Bradley Bender, MD -Ensure R&D and subcommittees have sufficient resources and support -Consulted by the R&D Committee and IRB Chair regarding suspension of research studies, after consideration of the best interest of individual subjects Associate Chief of Staff for Research – Paul Hoffman, MD −Responsible for the daily management of the R&D program, monitors and disseminates information regarding the HRPP Research & Development Committee −Responsible for reviewing and approving all proposed research in which NF/SGVHS is engaged. Affiliate IRB - UF IRB-01 −Responsible for protecting the rights and welfare of human subjects in research at, or conducted by faculty, staff, or students at the NF/SGVHS.

5. Accreditation is:  A mechanism to support quality improvement  An external validation of performance  A seal of approval from a trusted source Accreditation is NOT:  A guarantee  An audit

6. AAHRPP Accreditation… achieves its mission by using an accreditation process based on self-assessment, peer review, and … education.

7. AAHRPP Standards Domain I:Organization Domain II:Institutional Review Board or Ethics Committee Domain III:Researcher or Research Staff

8. To develop and maintain an OUTSTANDING HRPP!!

9. AAHRPP – Training Objectives −Protocol submission to UF IRB-01 and the VA R&D Committee −Reporting processes for VA and UF IRB- 01. −Resources at the VA and UF IRB-01 and how to access information. −Specific VA Requirements (e.g. consent documentation, required training)

10. Today’s Topics 1.Review who can conduct research and the approvals needed to initiate research activities 2.Review NF/SGVHS Research Processes 3.Review Investigator Obligations

11. Acronyms AAHRPP = Association for the Accreditation of Human Research Protection Programs HRPP = Human Research Protection Program IDE = Investigational Device Exemption IDS = Investigational Drug Study IND = Investigational New Drug PI = Principal Investigator SAE = Serious Adverse Event

12. UAP = UnAnticipated Problem UF IRB-01 = University of Florida Health Science Center Institutional Review Board VA R&D = VA Research & Development Committee WOC = WithOut Compensation Employee Acronyms

13. How is it all connected? HRPP Investigator VA Research Office IRB VA R&D Committee Research Compliance

14. VA Research ANY person who does NOT have a VA appointment and wishing to conduct research at NF/SGVHS must apply to Research Service for a WOC appointment. Policy for Status of Individuals to Conduct VA Research.

15. VA Policy to Conduct Research Residents, fellows, students cannot be PI’s on VA projects. However a written statement can be submitted by a VA appointed investigator who will serve as PI, requesting that the individual serve as an investigator on the project.

16. The VA-Appointed PI is Responsible for the Conduct of the Research Project at the VA

17. Who can help? UF IRB 01 staff −273-9600 −http://irb.ufl.edu/irb01/officeinfo.htmhttp://irb.ufl.edu/irb01/officeinfo.htm NF/SGVHS Research Service Staff −376-1611 x6069 −http://www.northflorida.va.gov/Research/i ndexResearchers.asphttp://www.northflorida.va.gov/Research/i ndexResearchers.asp NF/SGVHS Research Compliance Officer −376-1611 x5542

18. VA Research: Investigator Training Compliance Investigators and WOCs −ALL individuals who are involved in VA research must complete ANNUAL training as follows: CITI Training (Human Subjects Protection and GCP) *Information Security 201 is a one-time requirement for researchers VA Cyber Security Awareness VA Data Security & Privacy VHA Privacy Policy Training

19. Training Certificates Researchers are required to maintain proof of training Privacy Officer and Information Security Officer require proof of institutional trainings before approval of projects

20. Investigator Training Compliance UF IRB-01 Required Training −In addition to the VA training ALL research staff are required to complete the following UF training every 12 months: HIPAA for Researchers at the University of Florida

21. Training Compliance IMPORTANT!! ALL required training MUST be current BEFORE IRB or VA approval will be granted!

22. Protocol Submissions Prior to beginning ANY research activities at the VAMC the following approvals MUST be in place: SubCommittee for Research Safety (as appropriate) VA Radiation Safety Committee (as appropriate) Privacy Officer Information Security Officer UF Health Science Center IRB-01 (IRB) VA Research & Development Committee (R&D)

23. Protocol Submissions IRB approval should be obtained BEFORE R&D submission, however protocols may be submitted simultaneously. Privacy Officer final review requires stamped IRB documents

24. Protocol Submissions Following initial VA approval, ALL IRB actions must also be submitted to the VA Research Service for approval. These include the following:

25. Submit the following documents to VA Research Service after IRB approval  Revisions to Protocol  Revisions to Informed Consent  IRB Annual Renewals  Sponsor Changes (Letters from the Sponsor, DSMB reports)  Project Closure (send copy of IRB closure submission and IRB closure letter)

26. Submit to VA Research Office  VA Annual Renewals  Updated Training Certificates

27. IDS Requirements before a Drug Study Commences Investigational Drug Information Form [(IDIR) VAF 10-9012]- signed version R&D Approval [VAF 10-1223] Informed Consent [VAF 10-1086] Prescription [VAF 10-2577F] Initial meeting with Investigator and/or Study Coordinator Receipt of Study Supplies

28. Study Supplies Remember that ALL investigational agents are required by 1200.5 and 1108.04 to be routed through VA IDS. Under special circumstances, storage at another site is allowed, but this typically requires a Letter of Understanding (L.O.U.) signed by both institutions.

29. VA IDS Contacts Contact the VA Investigational Drug Service for more information −Matthew Morrow, CRP, RPM NF/SG (352) 374-6178, Pager 1755 matthew.morrow@va.gov −Scott Donelenko, CRP Lake City (386) 755-3016 x 3139 Scott.donelenko@va.gov −Kelly Parks, RA Extension 4369, Kelly.parks@va.gov

30. Submission Forms All project submission forms can be found on the UF IRB-01 and VA Research websites, including instructions and frequently asked questions. Always use the most recent form from the website!! UF IRB-01 −http://irb.ufl.edu/irb01http://irb.ufl.edu/irb01 VA Research −http://www.northflorid a.va.gov/Research/inde xResearchers.asphttp://www.northflorid a.va.gov/Research/inde xResearchers.asp

31. Valuable Researcher Tools The following items are helpful tools to assist researchers in the conduct of research at our institution: −IRB Position Papers −IRB-01 Help −IRB Bi-monthly Brown Bags

32. SAE’s and UAP’s must be reported to IRB and ACOS/R within 5 days More info on Unanticipated Problem available at: −http://irb.ufl.edu/irb01/help/upr.htmlhttp://irb.ufl.edu/irb01/help/upr.html More info on Serious Adverse Event available at: −http://irb.ufl.edu/irb01/help/aer.htmlhttp://irb.ufl.edu/irb01/help/aer.html

33. Conflict of Interest There are two classifications of Conflict of Interest −Institutional Conflict of Interest −Individual Conflict of Interest How is a potential COI disclosed −You must complete a conflict of interest form for each research project and update it if any changes −You must complete UF IRB-01 Addendum A and Addendum L as needed −All R&DC and sub-committee members must sign COI forms annually

34. Conflict of Interest COI evaluation is done by NF/SGVHS Conflict of Interest Administrator in conjunction with Regional Counsel and UF IRB01

35. Research Records All research records must be maintained according to VA Record Retention Schedule (indefinitely at this time) PI’s are responsible to maintain all study records PI’s are responsible to contact Research Service when relocating from NF/SGVHS

36. Informed Consent VA form 10-1086 must be used for VA research −IRB approved and stamped Witness signature is required on all VA Research Consent forms Consent progress note is required for each subject −CPRS documentation is required when subject has record −Other progress notes in Investigator Files Copies of all consent forms must be sent to Research Service for entry into CPRS

37. Subject Questions and Complaints Subjects may discuss questions and complaints with any member of NF/SGVHS Detailed information should be obtained and forwarded to ACOS/R, Research Service and/or the RCO in addition to the IRB

38. Things NOT to Say... in an AAHRPP Interview  I don’t know…  Let me tell you…  Or, for example..  IRB, what’s that?  I pay physicians $50 for every referral.  HIPAA, isn’t that an animal?  When the research is done I just let the study expire.  Isn’t pregnancy an adverse event?  Complaints? I advise my staff to ignore them.

39. Interview Tips Key points to REMEMBER… Keep answers short and to the point. If you don’t know the answer, be sure to know where to find it!