1. Questions: AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards Presented by: C. Karen Jeans, MSN, CCRN, CIP COACH Program Analyst, PRIDE

2. 2 DISCLAIMER The information presented in this webinar and in these slides does not represent formal positions of AAHRPP. Each of the issues addressed were queried to AAHRPP and this presentation represents responses to those issues.

3. 3 Topics for Today Brief Summary of Revised AAHRPP Standards and Evaluation Instrument Specific Questions and Answers on Selected Issues: Domain I Domain II

4. 4 Summary of Revised AAHRPP Standards for Accreditation Released October 1, 2009 Only 3 Domains 15 Standards and 60 Elements

5. 5 Summary of AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards Released October 1, 2009 Revised 2 times with most recent revision on November 13, 2009 Pending revision 114 Pages in Length Not VA Specific

6. 6 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states that the organization “should” define a systematic investigation and generalizable knowledge. Is “should” a “must”?

7. 7 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states that the organization “should” define a systematic investigation and generalizable knowledge. Is “should” a “must”? Answer: No.

8. 8 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states to provide guidance concerning activities which can or cannot be human research depending upon the intent, such as quality improvement. How specific does AAHRPP want it to be?

9. 9 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states to provide guidance concerning activities which can or cannot be human research depending upon the intent, such as quality improvement. How specific does AAHRPP want it to be? Answer: AAHRPP does not expect detailed specific guidance. One of the key issue is whether the activities are conducted with research intent.

10. 10 Specific Questions and Answers – Domain I: Organization Element I.1.D The Element requires policies and procedures to describe the ethical obligations and expectations of employees and students, yet it also addresses the requirement to describe the obligations and expectations of researchers and research staff, including students involved in the conduct of research. Is there a redundancy?

11. 11 Specific Questions and Answers – Domain I: Organization Element I.1.D The Element requires policies and procedures to describe the ethical obligations and expectations of employees and students, yet it also addresses the requirement to describe the obligations and expectations of researchers and research staff, including students involved in the conduct of research. Is there a redundancy? Answer: There is a level of redundancy with a caveat.

12. 12 Specific Questions and Answers – Domain I: Organization Element I.1.E The Element requires policies and procedures for actions the IRB takes if training requirements are not fulfilled. Will AAHRPP accept a general statement such as, “If training requirements are not fulfilled by the date required for renewal, the IRB will determine actions to be taken, which will include notification of the RCO and ACOS/R&D”?

13. 13 Specific Questions and Answers – Domain I: Organization Element I.1.E The Element requires policies and procedures for actions the IRB takes if training requirements are not fulfilled. Will AAHRPP accept a general statement such as, “If training requirements are not fulfilled by the date required for renewal, the IRB will determine actions to be taken, which will include notification of the RCO and ACOS/R&D”? Answer: No.

14. 14 Specific Questions and Answers – Domain I: Organization Element I.1.F How is AAHRPP defining “scientific review”?

15. 15 Specific Questions and Answers – Domain I: Organization Element I.1.F How is AAHRPP defining “scientific review”? Answer: AAHRPP is defining scientific review as it applies to the IRB approval criteria in 38 CFR 16.111 (a) (1-2) for purposes of evaluation of this Element. This is not referencing a scientific peer review process as used in merit reviews.

16. 16 Specific Questions and Answers – Domain I: Organization Element I.1.G What does AAHRPP mean when they state that policies and procedures describe the application of laws relevant to research involving humans as participants, when the research is conducted: * In the jurisdiction where the Organization resides * Outside the jurisdiction where the Organization resides?

17. 17 Specific Questions and Answers – Domain I: Organization Element I.1.G – Application of State Laws Answer: Where the subject is participating in the research is how applicable state laws are applied. It is not expected nor required that your HRPP SOPs state applicable state laws for all the states and U.S. territories.

18. 18 Specific Questions and Answers – Domain I: Organization Standard I-2 For organizations using the VA Central IRB or the IRB of an academic affiliate seeking its own AAHRPP accreditation, is AAHRPP expecting the Organization to conduct a secondary evaluation to ensure that it meets AAHRPP accreditation standards?

19. 19 Specific Questions and Answers – Domain I: Organization Standard I-2 For organizations using the VA Central IRB or the IRB of an academic affiliate seeking its own AAHRPP accreditation, is AAHRPP expecting the Organization to conduct a secondary evaluation to ensure that it meets AAHRPP accreditation standards? Answer: Not in the literal sense. AAHRPP is expecting your HRPP to include evaluation of that service or component outside of the organization as part of the evaluation of your HRPP.

20. 20 Specific Questions and Answers – Domain I: Organization Element I.4.C How is AAHRPP going to evaluate this element which addresses community-based participatory research designs in the absence of regulatory and guidance references?

21. 21 Specific Questions and Answers – Domain I: Organization Element I.4.C How is AAHRPP going to evaluate this element which addresses community-based participatory research designs in the absence of regulatory and guidance references? Answer: This is an exploratory element.

22. 22 Specific Questions and Answers – Domain I: Organization Element I.5.A This element requires the organization to state the goals of the quality improvement plan with respect to achieving and maintaining compliance. How specific should these goals be stated?

23. 23 Specific Questions and Answers – Domain I: Organization Element I.5.A – Goals of Quality Improvement Plan Answer: State at least one goal, such as “100% of all signatures required by VHA requirements will be present on IRB-approved informed consent forms” “No more than 10% of all active IRB-approved research studies will have lapses of IRB approval.”

24. 24 Specific Questions and Answers – Domain I: Organization Element I.5.B This element requires the organization to state the goals of the quality improvement plan with respect to achieving targeted levels of quality, efficiency, and effectiveness of the HRPP. Does AAHRPP require specific differentiation between measures of quality, efficiency, and effectiveness?

25. 25 Specific Questions and Answers – Domain I: Organization Element I.5.B This element requires the organization to state the goals of the quality improvement plan with respect to achieving targeted levels of quality, efficiency, and effectiveness of the HRPP. Does AAHRPP require specific differentiation between measures of quality, efficiency, and effectiveness? Answer: No

26. 26 Specific Questions and Answers – Domain I: Organization Element I.6.A This element addresses institutional conflict of interest issues. How does the evaluation of this element differ with this evaluation instrument compared to the 2007 evaluation instrument?

27. 27 Specific Questions and Answers – Domain I: Organization Element I.6.A This element addresses institutional conflict of interest issues. How does the evaluation of this element differ with this evaluation instrument compared to the 2007 evaluation instrument? Answer: It does not. Use Guidance Document on PRIDE SharePoint Site.

28. 28 Specific Questions and Answers – Domain I: Organization Element I.6.B This element addresses individual financial conflict of interest issues. How is the evaluation of this element differing with this evaluation instrument compared to the 2007 evaluation instrument?

29. 29 Specific Questions and Answers – Domain I: Organization Element I.6.B This element addresses individual financial conflict of interest issues. How is the evaluation of this element differing with this evaluation instrument compared to the 2007 evaluation instrument? Answer: It does not.

30. 30 Specific Questions and Answers – Domain I: Organization Element I.7.C This element states that policies and procedures consider emergency use of a test article to be a clinical investigation and under FDA regulations, that the patient is a participant, and that the FDA may require data from an emergency use to be reported in a marketing application. Is this an accurate statement?

31. 31 Specific Questions and Answers – Domain I: Organization Element I.7.C Answer: FDA may require data to be reported regardless of whether it is part of a marketing application.

32. 32 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.1.C This element requires the organization to have and follow written policies and procedures to separate competing business interests from ethics review functions. How does AAHRPP define business interests?

33. 33 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.1.C This element requires the organization to have and follow written policies and procedures to separate competing business interests from ethics review functions. How does AAHRPP define business interests? Answer: AAHRPP is primarily referencing those individuals in the private sector (for-profit institutions) whose have interests to promote the business.

34. 34 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C This element requires policies and procedures to describe the development of the agenda. Does AAHRPP require policies and procedures to place limits on the number of agenda items for a convened IRB meeting?

35. 35 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C This element requires policies and procedures to describe the development of the agenda. Does AAHRPP require policies and procedures to place limits on the number of agenda items for a convened IRB meeting? Answer: No. There is no requirement to place numerical limits on agenda items within an HRPP policy and procedure.

36. 36 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C This element requires policies and procedures to indicate that at least one unaffiliated member is present at convened meetings. Does AAHRPP require an unaffiliated member to be present during convened IRB meetings as part of quorum requirements?

37. 37 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C – Unaffiliated Member Answer: There are three possible ways to address this within policies and procedures: (a) Percentage rule: Members must be present at least (range) in convened IRB meetings to remain on the IRB (b) Passive Evaluation: As part of the HRPP evaluation, the attendance of the members is evaluated (c) Quorum requirement

38. 38 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.E Does AAHRPP require organizations to have policies and procedures listing specific types of modifications considered to be “minor”?

39. 39 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.E – Defining minor modifications Answer: No. They are expecting general guidance for IRB members to use, such as the following for protocols requiring review by the convened IRB: “Modifications are not minor if they represent substantial clarifications or modifications needed by the IRB in order to make determinations regarding the IRB approval criteria.” “ Modifications that require more than minimal evaluation (more than simple concurrence) are not minor and must be reviewed by the convened IRB.”

40. 40 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.G Does AAHRPP consider an “enrolled” participant to be a participant in whom informed consent has been obtained?

41. 41 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.G Does AAHRPP consider an “enrolled” participant to be a participant in whom informed consent has been obtained? Answer: Yes

42. 42 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.C This element requires organizations to have policies and procedures to include information that prospective participants need to determine their eligibility and interest, such as a summary of the criteria that will be used to determine eligibility in the study. Is AAHRPP stating that all criteria must be in advertisements?

43. 43 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.C Is AAHRPP stating that all criteria must be in advertisements? Answer: No. The information that will be included in advertisements will depend upon what the IRB determines is appropriate.

44. 44 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F This element requires organizations to have applications that include a description of the consent process, including the person who will provide consent or permission. Is AAHRPP requiring names of the individual obtaining consent to be placed in applications?

45. 45 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F This element requires organizations to have applications that include a description of the consent process, including the person who will provide consent or permission. Is AAHRPP requiring names of the individual obtaining consent to be placed in applications? Answer: No.

46. 46 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F This element states that the VA requires the long-form of consent documentation to include a statement that in the event of a research-related injury the VA has to provide necessary medical treatment to a subject injured by participation. Is this in conflict with VHA Handbook 1200.05 requirements?

47. 47 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F – Statement Regarding Compensation and Treatment for Research-Related Injuries Is this in conflict with VHA Handbook 1200.05 requirements? Answer: VHA Handbook 1200.05 only requires this statement to be included for research involving more than minimal risk.

48. 48 Summary This is an evolving evaluation instrument.

49. 49 Questions