Human Subject Protection Issues for HSR

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Office of Research Oversight

• Human Subject Protection Issues for HSRD
  Researchers
• Tom Puglisi, PhD, CIP
• Chief Research Oversight Officer
• HSRD National Meeting
• February 21-23, 2007

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Frequent Problem Areasin HSRD Research

• Research vs Quality Improvement
• Research vs Program Evaluation
• Compartmentalizing Project Activities
• Patients and Providers as Subjects
• Information Security
• Engagement

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Definition of Research38 CFR 16.102(d)

• A systemic investigation, designed to develop or
  contribute to generalizable knowledge.
• Includes research development, testing,
  evaluation
• May include demonstration and service programs
• Activities which meet this definition constitute
  research for purposes of this policy, whether or
  not they are conducted or supported under a
  program which is considered research for other
  purpose

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Research vsQuality Improvement

• Research is designed to develop or contribute
  to generalizable knowledge
• Design gt plan / methodology
• Design gt intention
• Prospective intention to conduct research
• Post Hoc intention to conduct research

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Research vsProgram Evaluation

• Independence of the Program Under Evaluation
• Research Team did not design the program
• Research Team did not implement the program
• Program existed prior to the evaluation
• Program will continue after the evaluation

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CompartmentalizingProject Activities

• The whole is greater than the sum of the parts
• Intent of the activity as a whole is critical to
  research vs non-research determination
• Unless activities and information access are
  strictly limited in writing, all members of the
  research team are generally accountable for the
  project as a whole, including their intellectual
  contributions

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Patients and Providersas Research Subjects

• Subjects may feel undue influence to
  participate
• Confidentiality risks are real
• Harm may be substantial

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Information Security

• Anonymous vs
• Not Identifiable
• De-identified
• Coded
• VA Security Requirements
• Storage
• Transmission
• Encryption

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Engagement in Research

• Federal Policy (Common Rule)
• 38 CFR 16.103(a)
• Each institution engaged in research conducted
  or supported by a Federal Department shall
  provide written assurance satisfactory to the
  Department that it will comply with the
  requirements set forth in this policy.

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General Consequences ofEngagement

• Federalwide Assurance (FWA) is REQUIRED
• Institutional Review Board (IRB) review and
  approval are USUALLY (but not always) REQUIRED

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Engagement in Human ResearchVHA Handbook 1200.5
3.b.

• A VA facility is engaged in human subject
  research (and needs an Assurance) whenever its
  employees or agents
• Intervene or interact with living individuals
• for research purposes, or
• Obtain, release, or access individually-identifiab
  le private information (or individually-identifiab
  le specimens) for research purposes
• See 38 CFR 16.102(f)

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VA Facilities Housing Research Repositories

• Are engaged in a human research activity (ie,
  maintaining a research repository)
• Facility IRB must review and approve protocol
  with
• Requirements for operating the repository
• Requirements for accepting, storing, and sharing
  data
• Requirements for maintaining privacy and
  confidentiality
• Are typically NOT considered involved in the
  conduct of individual projects using repository
  data
• Review of individual projects by Repository
  Facilitys IRB typically not required unless PI
  is also at the facility

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Critical Question IRB Review byNon-Engaged VA
Facilities

• When is the VA facility responsible for
  activities of non-facility researchers?
• Involving the facilitys patients but conducted
  outside the facility?
• Involving the facilitys employees but conducted
  outside the facility?

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Definition of Research38 CFR 16.102(d)

• Examples of HSRD Research

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Office of Research Oversight

• http//www1.va.gov/oro/
• 811 Vermont Avenue, N.W., Suite 574 (10R)
• Washington, D.C. 20420
• PHONE [phone]
• FAX [phone]