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

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Questions AAHRPP Evaluation Instrument for Use
with Final Revised Accreditation Standards

• Presented by
• C. Karen Jeans, MSN, CCRN, CIP
• COACH Program Analyst, PRIDE

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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.

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Topics for Today

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

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Summary of Revised AAHRPP Standards for
Accreditation

• Released October 1, 2009
• Only 3 Domains
• 15 Standards and 60 Elements

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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

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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?

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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.

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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?

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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.

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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?

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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.

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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?

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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.

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Specific Questions and Answers Domain I
Organization

• Element I.1.F
• How is AAHRPP defining scientific review?

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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.

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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?

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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.

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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?

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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.

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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?

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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.

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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?

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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.

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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?

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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

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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?

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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.

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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?

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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.

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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?

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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.

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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?

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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.

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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?

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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.

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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?

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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

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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?

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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.

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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?

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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

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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?

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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.

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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?

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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.

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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?

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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.

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Summary

• This is an evolving evaluation instrument.

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Questions