VA HRPP Accreditation

1. VA HRPP Accreditation December 15, 2011 Accreditation Conference Call

2. Conference Call Agenda • Introduction & Call Agenda • Accreditation Update • Site Visit Preparation Update • Frequently Cited Elements (FCEs) • I.5.D – Non-Compliance • I.4.B – Outreach Activities • Local Site Spotlight • Future Topics

3. Question Alerts Submit anytime Input

4. Accreditation Update

5. Accreditation Update: Year-to-Date Figures • 91 VA sites currently in Full Accreditation status • 12 VA sites currently in Accreditation Pending* • 1 VA site in the initial Accreditation process • 2 VA sites will submit initial application in 2012 • 29 Step 1 AAHRPP applications submitted • 1 VA site in Probation * One site awaiting reaccreditation of affiliate

6. Accreditation Update: Year-to-Date Figures • 39 accreditation site visits conducted • 32 sites received Full Accreditation/Reaccreditation on initial Council review • 5 of which had no observations/comments that warranted a response post-site visit • 16 sites required submission of an improvement plan • 21 sites lost Full Accreditation during the year

7. Site Visit Preparation

8. Site Visit Preparations E-mails from AAHRPP in the past have requested the following Food and Beverage preparations be provided to Site Visitors: • Water in all interview rooms • Soda and coffee in the records review room. • Facilitate lunch by take-out or delivery from a cafeteria or restaurant

9. Site Visit Preparations (continued) AAHRPP has agreed to remove reference to the provision of beverages from future e-mails sent to VA facilities • VA Contract with AAHRPP does not include the provision of food or beverages to site visitors • Federal Policy prohibits the payment of travel, transportation, or subsistence expenses of private parties at meetings(1) without specific statutory authority (31 USC 1345). • Additionally, payment for food or entertainment of nongovernmental personnel is equally impermissible except under specific statutory authority(2) • Note GAO has not defined precisely what types of gatherings fall within the scope of the statutory prohibition…. • United States. General Accounting Office, Office of the General Counsel. Principles of Federal Appropriations Law, Third Edition , Volume 1. Washington: GPO, 2004.

10. Frequently Cited Elements

11. Frequently Cited Element: I.5.D “The organization has and follows written policies and procedures for addressing allegations and findings of non-compliance with Human Research Protection Program requirements. The organization works with the IRB or Ethics Committee, when appropriate, to ensure that participants are protected when non-compliance occurs. Such policies and procedures include reporting these actions, when appropriate”.

12. VHA Research Noncompliance Reporting Requirements

13. Element I.5.D: Expectations The following are outlined in policies and procedures: • Definitions pertaining to categories of non-compliance: • non-compliance • serious non-compliance • continuing non-compliance • Mechanisms for receiving reports of non-compliance from different sources

14. Element I.5.D: Expectations (continued) Policies and procedures include the following: • Who reviews non-compliance to determine if it has a basis in fact • Who reviews and evaluates each category of non-compliance • How each category of non-compliance is resolved/managed

15. Element I.5.D: Expectations (continued) Policies and procedures include the following: • Who does the incident have to be reported to and when

16. Element I.5.D: Common materials that may be used to meet the element • SOPs • Non-Compliance Reporting and Review Forms • Meeting Minutes • Correspondence • See AAHRPP Tip Sheet 14 and VHA Handbook 1058.01 for specific information that should be included in an SOP (http://www.aahrpp.org/Documents/D000141.PDF)

17. Element I.5.D: AAHRPP Frequently Cited Issues* • Policies/procedures do not require reporting of serious or continuing non-compliance to DoD for DoD-supported research • Serious or continuing non-compliance not reported to OHRP/FDA when required • No documentation by convened IRB as to whether non-compliance is serious or continuing * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports

18. Element I.5.D: AAHRPP Frequently Cited Issues (cont…)* • IRB Members and staff not knowledgeable of process for reviewing incidents of non-compliance • Discrepancy between policy and reality as to who actually reviews non-compliance determined to be neither serious or continuing * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports

19. 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.

20. Frequently Cited Element: I.4.B “The Organization conducts activities designed to enhance understanding of human research by participants, prospective participants, or their communities, when appropriate. These activities are evaluated on a regular basis for improvement”.

21. Outreach Activities Poll

22. Element I.4.B: Expectations • Information designed to enhance the understanding of research is provided to participants, prospective participants and the community • Venues are made available for research participants and their designated representatives to obtain information, discuss their questions and concerns, and offer their input • When appropriate, research participants and their communities are invited to attend educational activities pertaining to research

23. Element I.4.B: Expectations (continued…) • Outreach activities are evaluated and results are used to enhance the Institution’s HRPP • Researchers and Research Office Staff are knowledgeable of the characteristics and culture of the communities in which the Institution conducts research

24. Element I.4.B: Common materials that may be used to meet the element • Distribution of pamphlets and brochures about research • Area on website soliciting feedback • Research week activities • Research office booth • Researcher presentations • Presentations by research subjects • Completion of anonymous surveys to solicit feedback • Contact information on Informed Consent Form • Mechanism for receiving and addressing complaints

25. Element I.4.B: Common materials that may be used to meet the element • Presentations to Veterans Groups • Presentation by research staff at hospital organized events/retreats for subjects and potential subjects • Forums/group meetings organized by clinic areas for patients and other potential subjects focused on research • Profiling of researchers and their research on hospital audiovisual systems • Focus groups of veterans and other potential subjects to help inform investigators in planning studies (e.g. MVP)

26. Element I.4.B: Unique Practices • Research office staff contact research participants to assess satisfaction with their research experience* • ACOS/R or designee provides information on research and solicits input from Veterans during Medical Center’s bi-weekly new patient orientation • When appropriate, inform subjects of outcome of study by mailing copies of publications, abstracts, etc. *Permission obtained a priori in ICF

27. Element I.4.B: Unique Practices • Highlight recent research findings of potential interest to patients on bulletin board in clinical research center • Have an R&D or clinical research staff member sit at a table in hospital lobby on a monthly basis to: • Answer questions about research • Solicit feedback from veterans via use of an anonymous survey • Distribute research-related brochures

28. Element 1.4.B: AAHRPP Frequently Cited Issues* • Failure to evaluate and make improvements to the Institution’s outreach program/activities • Failure to designate an individual/group responsible for evaluating the Institution’s outreach program/activities • With the exception of the ORD brochure, participants not provided with information designed to enhance their understanding of research * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports

29. 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.

30. Local Site Spotlight: Community Outreach Activities Krissa Caroff, CIP Research Education and Policy Coordinator VA Pittsburgh Healthcare System

31. Future Topics

32. Future Topics Poll

33. Future Topics • Next call will be in February 2012 • Focus area: ???? • 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 elements discussed today • E-mail Ashleigh.wyble@va.gov to receive notices of future calls