VA Research Julie Doherty RN, MSN, CCRC Research Compliance Office VA Maryland Health Care System

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VA ResearchJulie Doherty RN, MSN, CCRCResearch
Compliance OfficeVA Maryland Health Care System
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Signatories to Common Rule

• Department of Health and Human Services 45 CFR
  46
• Department of Veterans Affairs 38 CFR 16

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VA Requirements

• NCQA
• IRB Composition
• Informed Consent
• Special Considerations
• Fetuses
• Prisoners
• Children
• Tissue Banking

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National Committee on Quality Assurance

• Accreditation mandatory for VA
• NCQA visit - Feb 2005
• AAHRPP visit to University of Maryland
• Combine score for accreditation

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IRB Composition

• Two or more VA employees ( 5/8ths VA) as voting
  members of each committee that reviews VA
  research
• VA member is full member of the IRB (reviews
  non-VA research matters coming before the IRB)
• At least one member is present during review of
  VA research
• For FDA regulated research, IRB quorum must
  include a licensed physician

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Veterans

• Subject rights Do not lose benefits to which
  they are otherwise entitled

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Process

• IRB approval
• VA RD Approval
• Recruiting veterans
• Using VA facilities (labs, radiology, space)

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Informed Consent

• VA 10-1086 Witness Signature
• VA injury statement 38 CFR 17.85
• If subject is injured as a result of their
  
• participation in a research study ( not a
  result
• of non-compliance), VA will pay for their
• care.
• Applies to minimal and greater than minimal
• risk research

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Special Considerations

• The following research may not be conducted by VA
  investigators while on official duty, or at VA
  facilities, or at approved off-site facilities
• Research in which fetus is subject
• In vitro fertilization

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Special Considerations

• Prisoners only after waiver granted by the
  Chief Research Development Officer (CRADO)
• IRB must first approve in accordance with
  applicable Federal regulations (45 CFR 46
  Subpart C 46.301-306)
• VA RD Committee must also approve prior to
  applying for waiver

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Special Considerations

• Children
• Congressionally mandated OR
• After waiver granted by Chief Research
  Development Officer (CRADO)

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Special Considerations

• Children (cont.)
• IRB must first approve in accordance with
  applicable Federal regulations (45 CFR 46,
  Subpart D 46.401-46.409)
• VA RD Committee must also approve prior to
  applying for waiver

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Special Considerations

• Tissue Banking
• Banked specimen - specimens collected and stored
  for future research that are not specified in the
  original research protocol

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Tissue Banking

• Specimens must be stored at an approved
• VA sponsored tissue bank located at a VA
  facility or an approved off-site location
• NCI, MAVERIC,

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Tissue Banking

• VA approved tissue bank
• Located at non-VA facility that has appropriate
  approval from VA ORD.
• Non-VA sites that are not acceptable as VA
  approved tissue banks are non-academic,
  for-profit institutions such as pharmaceutical
  companies

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• QUESTIONS ???