1. Sherry Davis, Manager Pacific Northwest National Laboratory Human Research Protection Program AAHRPP As A Self-Assessment Tool May, 2008

2. 2 Accreditation Process Self Assessment - AAHRPP Evaluation Instrument Revise Program to AAHRPP Standards Submit Preliminary Application AAHRPP Response Revise Program and Submit Final Application AAHRPP Site Visit Site Visit Report Submit Response to Site Visit Report To Council on Accreditation 60 Days 30 Days

3. 3 AAHRPP Approach Five Domains Organization Research Review Unit Investigators Sponsored Research Participant (Community) Outreach

4. 4 First Step - Perform Gap Analysis 77 Elements Assess Policies and Procedures Using: Modified AAHRPP Self-Assessment Tool Applicable Regulations OHRP Guidance AAHRPP Tip Sheets Other HRPP Examples Focus on Outcome

5. 5 OutcomeOutcome What outcome is expected? Are written policies and procedures sufficient to achieve the outcome?

6. 6 Example – The Institutional Official Who is your Institutional Official? What are the IOs duties? When is s/he required to perform those duties? Where is s/he located in the organization? Why have an Institutional Official? How is s/he appointed, educated, kept informed?

7. 7 Policies and Procedures Should describe operational steps required to meet regulatory and guidance requirements Must be “written” May be other written guidance - SOPs, policy statements, checklists, guidelines, etc. Can include other referenced P&Ps - corporate ethics., etc.

8. 8 Policies and Procedures (cont) Should: Reflect actual practice Provide enough detail to be understandable Incorporate or reference the regulations Provide interpretations for key regulatory terms “Non-compliance” Describe the actions that are taken Describe the person who performs the actions Describe the timing of the actions

9. 9 TipsTips Cite regulations verbatim Don’t create unnecessary policies and procedures Use simple, consistent formats Make sure directions and forms are consistent Write once, refer many (WORM) Reporting Use same procedures - Expedited Review Initial Review Modifications/Changes Continuing Review Use OHRP Charts/Guidance Use AAHRPP Tip Sheets

10. 10 Problem Areas Conflict of Interest Institutional IRB Members/Consultants Researchers/Immediate family members FDA Reporting Adverse Events and Unanticipated Problems Reporting Noncompliance and Allegations of Noncompliance Expedited Review

11. 11 AAHRPP Site Visit - Expectations Visible organizational awareness and support Clear lines of communication, authority and responsibility Policies and procedures: Meet regulatory requirements Appropriate for program needs Clearly documented, communicated, implemented and enforced Adhered to in actual practice

12. 12 ChallengesChallenges Painfully long and frustrating process Demand on staff time and resources Difficult to maintain routine work duties DOE mind-set difficult for “outsiders” Not as flexible as purported to be Confusing written communications Mixed messages Unreasonable/crushing response times

13. 13 Challenges (cont.) Typically 2-3 years to complete Initial state of program Number of staff assigned Other responsibilities/demands Perpetual Maintenance AAHRPP annual and other reporting requirements Full application for re-accreditation every 3 years Expensive

14. 14 On the Positive Side… Excellent Way to Improve Program In-depth program assessment Improved and developed new policies and procedures documentation Standardization and consistency Better understanding and implementation of the regulations Encourages continual improvement Enhanced communication and awareness of the HRPP Client and Peer (OHRP) recognition Marketing Tool (Proposals)