VA HRPP Accreditation

1. VA HRPP Accreditation October 18, 2011 Accreditation Conference Call PRIDE/Soundia Duche, MA, MS

2. Conference Call Agenda • Introduction & Call Agenda • Accreditation Update • Director’s Topic: Accreditation Pending • Frequently Cited Elements (FCEs) • Local Site Spotlight • Future Topics

3. Question Alerts Submit anytime Input

4. Accreditation Update

5. Accreditation Update: Year-to-Date Figures • 94 VA sites currently have Full Accreditation • 9 VA sites currently in Accreditation Pending* • 3 VA sites are in initial Accreditation process • 2 VA sites will submit initial application in 2012 • 29 Step 1 AAHRPP applications submitted * One site awaiting reaccreditation of affiliate

6. Accreditation Update: Year-to-Date Figures • 32 accreditation site visits conducted • 21 sites received Full Accreditation/Reaccreditation on initial Council review • 5 of which had no observations/comments that warranted a response post-site visit • 7 sites required submission of an improvement plan • 14 sites lost Full Accreditation during the year

7. Accreditation Pending

8. Accreditation Pending • Nine sites currently in reaccreditation pending* • VHA Handbook 1200.05 requires that sites maintain Full Accreditation • Change in accreditation status is a reportable event to ORO Central Office within 5 working days (VHA Handbooks 1200.05 Section 64d. and 1058.01 Section 7k.) * One site awaiting affiliate reaccreditation

9. Accreditation Pending: Common Reasons • Failure to include plans for monitoring the effect of proposed changes to policies and procedures when submitting response to the draft site visit report • Failure to completely address issues/tasks and provide evidence of completion to AAHRPP when submitting response to the draft site visit report • Failure to submit status report by deadline

10. Questions Input your name, facility name, and question topic into the Q&A box at the top of the screen to alert us that you have a question. Any unanswered questions in this segment will be saved for the end of the presentation.

11. Frequently Cited Elements

12. Frequently Cited Element: I.5.B The organization conducts audits or surveys or uses other methods to assess the quality, efficiency and effectiveness of the Human Research Protection Program (HRPP). The organization identifies strengths and weaknesses of the HRPP and makes improvements, when necessary, to increase the quality, efficiency, and effectiveness of the program.

13. Element I.5.B: Expectations • Existence of a quality improvement plan • At least one objective and at least one measure is defined • Frequency and responsible party for assessment specified • Results used to implement improvements to the HRPP

14. Element I.5.B: Common materials that may be used to meet the element Review of metrics such as: • Turnaround time for expedited and convened IRB review • # of lapsed projects • # of resolved complaints from investigators/participants • # of reportable events to ORO/external agencies • # of deviations; SAEs; unanticipated problems involving risks to others • # of correct category determinations for exempt/expedited reviews Audits; surveys; or other data collection tools • Periodic audit of minutes; protocols files; RCO audits • Budgetary/resource review • Customer satisfaction surveys Evaluation reports • IRB member and Chair evaluation reports

15. Element I.5.B: Frequently Cited Issues* • RCO annual audits of informed consent form and triennial regulatory audits of research projects are not sufficient to successfully meet the requirements of this element • No systematic/formal process to periodically measure quality, efficiency, and effectiveness of the HRPP • Plan does not include at least one goal and at least one measure of quality, efficiency, and effectiveness * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports

16. Element I.5.B: Frequently Cited Issues (cont…)* • No process described to make improvements when necessary • Audit findings not evaluated by the HRPP and not used to make improvements when necessary • Quality improvement plan still in draft form/not yet implemented * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports

17. Questions??? Input your name, facility name, and question topic into the Q&A box at the top of the screen to alert us that you have a question. Any unanswered questions in this segment will be saved for the end of the presentation.

18. Frequently Cited Element: II.1.B II.1.B – The IRB or EC has qualified leadership (e.g., chair and vice chair) and qualified members and staff. Membership and composition of the IRB or EC are periodically reviewed and adjusted as appropriate.

19. Element II.1.B: Expectations Policies and procedures include the following: • Requirements to be an IRB Chair; Member; Staff; and Alternate Member • Who is responsible for appointing Chair and members • Appointment tenure for Chair and members • Function of alternates should be specified • Function of any non-voting members assigned to the IRB should be specified

20. Element II.1.B: Expectations (continued…) Policies and procedures include the following: • Training requirements • How each member is periodically evaluated; • Who is responsible for suspending/terminating IRB membership

21. Element II.1.B: Common materials that may be used to meet the element • SOPs • Appointment Letters • Training Records • IRB Member, Chair, and Staff Evaluation Instrument • See AAHRPP Tip Sheet 7 for examples of content for evaluation of each category of individual (http://www.aahrpp.org/Documents/D000264.PDF)

22. Element II.1.B: Frequently Cited Issues* • Evaluation of IRB Chair and members did not occur • Evaluation of IRB Chair and members occurred, however no individual feedback provided • IRB members not aware that they had been evaluated • IRB members not knowledgeable of some of the regulatory approval criteria • No one evaluated the membership and composition of the IRB to ensure that it continues to meet regulatory and organizational requirements * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports

23. Questions??? Input your name, facility name, and question topic into the Q&A box at the top of the screen to alert us that you have a question. Any unanswered questions in this segment will be saved for the end of the presentation.

24. Local Site Spotlight: Informed Consent Education Overton Brooks VAMC Shreveport, LA

25. Target Audience • Investigator initiated studies • Studies without monitors • Studies with known compliance issues WHY??? Because lack of knowledge & inexperience can lead to Non-Compliance

26. Educational Process • R&D Committee & IRB approvals received • Meeting scheduled with PI & Staff • Pre-Study Monitoring Questionnaire reviews: • Protocol knowledge & recruitment process • Inclusion/exclusion criteria • Definitions & processes for modifications, SAEs/Unanticipated Problems • CPRS assistance provided for flagging, etc.

27. Observation of Informed Consent Process • After education PI notifies RCO when first subject to be consented • RCO observes the consent process • RCO provides suggestions on how to improve process • Assistance provided in completing CPRS template

28. Common RCO Observations • Ensure all aspects of the consent were covered • Information presented in a manner to ensure subject’s understanding • Questions were asked to ensure subject’s understanding • No undue influence used

29. Questions?? Contacts: Lyndie Carter, RN, RCO Lyndie.Carter@va.gov Dorothy Jarzabek, AO/Research Dorothy.Jarzabek@va.gov

30. Remaining Questions??? Input your name, facility name, and question topic into the Q&A box at the top of the screen to alert us that you have a question. Any unanswered questions in this segment will be saved for the end of the presentation.

31. Future Topics

32. Future Topics • Next call will be in December 2011 • Focus area: Community outreach activities • E-mail soundia.duche@va.gov with suggestions for: • Future conference call topics • Exceptional forms/tools used at your site for the elements discussed today • Innovative practices used at your site that are related to community outreach activities