VA HRPP Accreditation

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VA HRPP Accreditation

• December 15, 2011
• Accreditation Conference Call

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Conference Call Agenda

• Introduction Call Agenda
• Accreditation Update
• Site Visit Preparation Update
• Frequently Cited Elements (FCEs)
• I.5.D Non-Compliance
• I.4.B Outreach Activities
• Local Site Spotlight
• Future Topics

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Question Alerts
Submit anytime
Input
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• Accreditation Update

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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
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Accreditation Update Year-to-Date Figures

• 39 accreditation site visits conducted
• 32 sites received Full Accreditation/Reaccreditat
  ion 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

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• Site Visit Preparation

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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

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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.

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• Frequently Cited Elements

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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.

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VHA Research Noncompliance Reporting
Requirements
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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

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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

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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 Key Entities
Med Center Director FDA
ACOS/R OHRP
RD Committee DoD
ORD Study Sponsor
ORO Others
VA Privacy Officer
VA Information Security Officer
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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)

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Element I.5.D AAHRPP Frequently Cited Issues

• 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

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

• 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

Derived from Areas of Concern cited in 2011
VA Draft Site Visit Reports
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• Questions???
• Input your name, facility name, and question
  topic
• into the QA 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.

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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.

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Outreach Activities Poll
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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

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Element I.4.B Expectations (continued)

• Outreach activities are evaluated and results are
  used to enhance the Institutions HRPP
• Researchers and Research Office Staff are
  knowledgeable of the characteristics and culture
  of the communities in which the Institution
  conducts research

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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

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Element I.4.B Common materials that may be used
to meet the element

• 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)

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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 Centers 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
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Element I.4.B Unique Practices

• Highlight recent research findings of potential
  interest to patients on bulletin board in
  clinical research center
• Have an RD 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

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Element 1.4.B AAHRPP Frequently Cited Issues

• Failure to evaluate and make improvements to the
  Institutions outreach program/activities
• Failure to designate an individual/group
  responsible for evaluating the Institutions
  outreach program/activities
• With the exception of the ORD brochure,
  participants not provided with information
  designed to enhance their understanding of
  research

Derived from Areas of Concern cited in 2011
VA Draft Site Visit Reports
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• Questions???
• Input your name, facility name, and question
  topic
• into the QA 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.

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• Local Site Spotlight
• Community Outreach Activities
• Krissa Caroff, CIP
• Research Education and Policy Coordinator
• VA Pittsburgh Healthcare System

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• Future Topics

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Future Topics Poll
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Future Topics

• Next call will be in February 2012
• Focus area ????
• E-mail soundia.duche_at_va.gov with suggestions for
• 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_at_va.gov to receive notices
  of future calls