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Title: Questions: AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards


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

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

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
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
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
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
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
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
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
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/RD?

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/RD?
  • Answer No.

14
Specific Questions and Answers Domain I
Organization
  • Element I.1.F
  • How is AAHRPP defining scientific review?

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Summary
  • This is an evolving evaluation instrument.

49
Questions
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