INTERNATIONAL RESEARCH IN THE DEPARTMENT OF VETERANS AFFAIRS

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INTERNATIONAL RESEARCH IN THE DEPARTMENT OF
VETERANS AFFAIRS

• Brenda Cuccherini, Ph.D., M.P.H. Office of
  Research Development
• Joan P. Porter, D.P.A., M.P.H. Office
  of Research Oversight
• Society of Research Administrators International
• October 17, 2005

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What is International Research?

• Any VA research approved by an RD Committee
  that involves human subjects, human biological
  specimens, or human data conducted at
  international sites (not within the United
  States, its territories or Commonwealths).

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Multi-Site Trials

• Considered international research when
• VA is the sponsor, or
• VA functions as the coordinating center, or
• VA subcontracts to a foreign site, or
• The primary investigator for the total project is
  a VA investigator
• Not considered international research when
• VA is only one of the participating sites and
  does not meet one of the above conditions

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Why Have a Policy?

• Ensure
• Appropriate ethical review
• Compliance with the Common RuleGood international
  relationships
• VAs PIs, IRBs RD Committees understand local
  context of research
• Sufficient, efficient, timely communications
• Clearly defined roles for all at VA at
  international sites
• Define minimal information necessary for IRB and
  RD Committee reviews
• J

5
Recently Identified Issues with International
Research

• Scenario 1 Children entered into research at
  foreign site without IRB knowledge or without
  obtaining an informed consent
• Scenario 2 OHRP suspends one of its
  international assurances
• Scenario 3 Research is insufficiently monitored
  on site and data are rejected by FDA adverse
  events are not reported properly so data validity
  suspect
• J

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International Research ORDs Activities

• Drafted new VHA policy All new studies require
  permission of the CRADO
• Consultation with ORO, Ethics, other Federal
  Agencies
• Status of draft policy
• Developing guidance required information for
  submission of request to CRADO

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Information Required (draft)

• Protocol with description of human subjects
  involvement
• Risks and benefits
• Interventions
• Source of data or biological specimens
• Description of each foreign site
• Facilities
• Investigators
• Principles governing research
• Ethics committee
• Assurances, if any
• Copy of approvals from foreign site(s)

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Information Required (draft) 2

• Communication plan
• Financial arrangements
• Liability issues
• Monitoring reports
• Frequency
• Reviewed by whom
• Plan for oversight
• Informed consents
• IRB/ethics/RD Committee approvals

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As We Begin

• It is better to know some of the questions
  then all the answers.
• James Thurber 1894-1961

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With Experience Comes Answers

• Many questions remain
• Few absolutes in how to apply equivalent
  protections
• Need to continue exploring how best to protect
  subject regardless of geographic location
• J

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A New Geographic Location for Research

• We are in Transylvania, and Transylvania is
  not England. Our ways are not your ways, and
  there shall be to you many strange things.
• Bram
  Stoker
• 
  Dracula
  

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OROs Current Role

• Survey currently active research
• Routine reviews
• For cause reviews
• Close communication with ORD
• J

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Future Steps

• ORD develops more information based on
• Experience with new policy
• Federal-wide committee activities
• ORO receives information
• Site visits,reviews
• Inquires
• ORO may include International Assurances in their
  assurance handbook
• ORD ORO continue to share information
• ORD will develop a more detailed Handbook and
  guidance
• J

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Other Initiatives

• HSRS evaluating other Federal Agencies and
  Departments policies and procedures
• VA Office of Intergovernmental Relations
  developing its role within VA and procedures for
  reporting international sites to Department of
  State
• J

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• There is a loftier ambition than merely to
  stand high in the world. It is to stoop down and
  lift mankind a little.
• Henry Van Dyke 1852-1933
• American clergyman, educator author