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

2. 2 Conference Call Agenda 1.Introduction & Call Agenda 2.Accreditation Update 3.Site Visit Preparation Update 4.Frequently Cited Elements (FCEs) i.I.5.D – Non-Compliance ii.I.4.B – Outreach Activities 5.Local Site Spotlight 6.Future Topics

3. 3 Question Alerts Input Submit anytime

4. 4 Accreditation Update

5. 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. 6 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 Accreditation Update: Year-to-Date Figures

7. 7 Site Visit Preparation

8. 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. 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) (1)Note GAO has not defined precisely what types of gatherings fall within the scope of the statutory prohibition…. (2)United States. General Accounting Office, Office of the General Counsel. Principles of Federal Appropriations Law, Third Edition, Volume 1. Washington: GPO, 2004.

10. 10 Frequently Cited Elements

11. 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. 12 VHA Research Noncompliance Reporting Requirements

13. 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. 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. 15 Element I.5.D: Expectations (continued) Policies and procedures include the following: –Who does the incident have to be reported to and when Key Entities Med Center DirectorFDA ACOS/ROHRP R&D CommitteeDoD ORDStudy Sponsor OROOthers VA Privacy Officer VA Information Security Officer

16. 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) http://www.aahrpp.org/Documents/D000141.PDF

17. 17 Element I.5.D: AAHRPP Frequently Cited Issues* * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports 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

18. 18 Element I.5.D: AAHRPP Frequently Cited Issues (cont…)* * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports 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

19. 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. 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. 21 Outreach Activities Poll

22. 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. 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. 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. 25 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) Element I.4.B: Common materials that may be used to meet the element

26. 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. 27 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 Element I.4.B: Unique Practices

28. 28 Element 1.4.B: AAHRPP Frequently Cited Issues* * Derived from “Areas of Concern” cited in 2011 VA Draft Site Visit Reports 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

29. 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. 30 Local Site Spotlight: Community Outreach Activities Krissa Caroff, CIP Research Education and Policy Coordinator VA Pittsburgh Healthcare System

31. 31 Future Topics

32. 32 Future Topics Poll

33. 33 Future Topics Next call will be in February 2012 Focus area: ???? E-mail soundia.duche@va.gov with suggestions for:soundia.duche@va.gov –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 callsAshleigh.wyble@va.gov