VHA Handbook 1058'03

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Office of Research Oversight

• VHA Handbook 1058.03
• Assurance of Protection for Human Subjects May
  10, 2007

2
VHA 1058.03 2b(1)(2)Assurance Required

• Each entity engaged in human research conducted
  or supported by VA must provide a written
  Assurance to comply with the Federal Policy for
  the Protection of Human Subjects (38 CFR Part 16)
• VA Facilities
• Non-VA Institutions

3
VHA 1058.03 4bVA Facility Operated by VA

• Includes all components within the facilitys
  management control
• Regardless of physical location
• Space owned, leased, rented by VA
• Space shared with non-VA entity, unless leased
  to the non-VA entity and not used by VA for
  research

4
VHA 1058.03 4i(1)Non-VA Operated Institution

• Entities operated under a contract from a VA (eg,
  Contract CBOC)
• VA-Affiliated Non-Profit Research and Education
  Corporations (NPCs)
• Contract Research Organization (CRO)
• Industry or Private Sponsor
• Public or private company, foundation, or group

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VHA 1058.03 4jVA vs Non-VA Investigator

• Any individual conducting human research while
  acting under a VA appointment
• Full Time
• Part Time
• Without Compensation (WOC)
• Intergovernmental Personnel Act (IPA)
• Non-VA Investigator gt anybody else

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VHA 1058.03 5aAssurances VA Addenda

• Assurance for VA Facilities
• OHRP Federalwide Assurance (FWA)
• ORO may rarely issue Special Assurance or
  recognize other Common Rule Assurance
• Assurance signed by Facility Director as
  Institutional Official
• Signature cannot be delegated for short-term
  absences
• VA Addendum signed by ORO
• Signed by Facility Director VISN Director

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VHA 1058.03 5a-gAssurances for VA Facilities

• Submitted through ORO
• initial, renewal, modified
• May be restricted or suspended by ORO Chief
  Officer
• Must cover all research conducted at facility
• Must cover all research conducted by the
  facilitys investigators acting as VA employees

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VHA 1058.03 5a-gAssurances for VA Facilities

• May be applied to employee of another VA Facility
  with approval of ORO and ORD (rare)
• May not include or apply to a non-VA institution
  or non-VA personnel without approval of
• CRADO
• ORO Chief Officer
• VHACO Office of General Counsel (OGC)

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VHA 1058.03 6a-eIRBs for VA Facilities

• VA-operated, affiliate-operated, or other per VHA
  1200.5
• Registration, renewal, and modification of
  VA-operated IRBs submitted through ORO
• VA facility must notify ORO of roster changes
  within 30 days, regardless of operating entity
• IRB must comply with all VA requirements
• VA-operated IRBs may not be used by non-VA
  entities

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VHA 1058.03 6a-eIRBs for VA Facilities

• MOU needed where IRB is operated by a non-VA
  entity
• MOU OHRP IRB Authorization Agreement
• Signed MOU submitted to ORO with initial/renewal
  FWAs

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VHA 1058.03 7a-eChanging Review Arrangements

• Designation of new IRB(s) under FWA
• Transition MOUs and SOPs as practicable
• New MOUs and SOPs
• New IRB must review all projects for which it
  will assume oversight
• Remove old IRB(s) from FWA

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VHA 1058.03 8aAssurances for Non-VA Entities

• VA-Supported Research / Assurance Needed
• Use of VA facilities, resources, or equipment
• Transfer from or through VA of funds, equipment,
  or other tangible resources
• Transfer to, from, or through VA of human
  biological specimens or private information
  unless deidentified under HIPAA and not
  identifiable under human subject protection
  regulations
• Intellectual contributions meriting publication
  authorship

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VHA 1058.03 8aAssurances for Non-VA Entities

• VA-Supported Research / Assurance Needed
• Study-wide VA sponsorship of trial
• VA or VA employee holds IND or IDE
• VA employee serves as study-wide PI
• VA facility serves as study-wide operations or
  statistical center
• VA facility operates study-wide data or specimen
  repository, unless deidentified under HIPAA and
  not identifiable under human subject protection
  regulations

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VHA 1058.03 8bAssurances for Non-VA Entities

• Not VA Supported / No Assurance Needed
• Transfer to or from a VA facility of human
  biological specimens or private information that
  are both deidentified under HIPAA and not
  identifiable under human subject protection
  regulations
• Intellectual, professional, or non-research
  contributions that do not merit authorship credit
• Participation by a VA facility as a research site
  in a multisite clinical trial (except as noted
  previously)

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VHA 1058.03 8fAssurances for Non-VA Entities

• Not VA Supported / No Assurance Needed, but
• VA Facility should seek confirmation that
• Participating institutions adhere to appropriate
  national, international, or study-wide standards
• Deidentified / Not Identifiable data and/or
  specimens have been obtained in accordance with
  widely accepted human protection standards

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VHA 1058.03 9aInitiating Human Research Program

• Contact ORO RO and ORD ASAP
• Notify ORO CO through VISN in writing
• Notify ORD through VISN in writing
• RD Committee Established
• RD Committee
• Identify/Establish/Train IRB for FWA
• Submit FWA
• No Human Research until FWA approved

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VHA 1058.03 9bClosing Human Research Program

• Contact ORO RO and ORD ASAP
• Notify ORO CO through VISN in writing
• Notify ORD through VISN in writing
• IRB and RD Committee Supervise transfer or
  termination of studies
• Maintain IRB RD Committee oversight until all
  studies transferred or closed
• ORO officially deactivates Assurance and IRB

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Office of Research Oversight

• http//www.1.va.gov/oro/
• 811 Vermont Avenue, N.W., Suite 574 (10R)
• Washington, D.C. 20420
• PHONE [phone]
• FAX [phone]