Engagement in Human Research

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Office of Research Oversight

• Engagement in Human Research
• Tom Puglisi, PhD, CIP
• ORD COACH Conference on
• Local Accountability for Human Research
  Protection
  
• Fall 2006

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Assurance Requirement Based on Engagement

• 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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Applicability VHA Handbook 1200.5 3.b.

• VA Facility that Conducts or Supports Research
• VA Facility of Engaged Employee or Agent
• Collaborators of Engaged VA Facility
• Other VA Facilities
• Other Government Entities
• Non-Government Entities

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Engagementin Human Research38 CFR 16.103(a) -
Conduct or Support

• A VA facility is engaged in research when it
• Sponsors human research (single site or
  multi-site)
  
• Holds the IND or IDE for FDA-regulated clinical
  investigations
  
• Provides the use of its facilities, resources, or
  equipment for the conduct of the research
  
• Transfers funds to another entity for research

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Engagementin Human ResearchVHA Handbook 1200.5
3.b.

• A VA facility is engaged in human subject
  research whenever its employees or agents
  
• Intervene or interact with living individuals
• for research purposes, or
• Obtain, release, or access individually-identifiab
  le private information (individually-identifiable
  specimens) for research purposes

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Examples of Engagement OHRP Guidance January
1999

• Intervention for Research Purposes
• Collecting biological specimens
• Administering treatment
• Dispensing drugs
• Using invasive or non-invasive tests

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Examples of Engagement OHRP Guidance January
1999

• Interaction for Research Purposes
• Protocol-specified communication
• Interpersonal contact
• Surveys and interviews
• Obtaining informed consent

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Examples of Engagement OHRP Guidance January
1999

• Obtaining, receiving, or possessing individually
  identifiable private information
  
• Direct identifiers
• Names, social security numbers, medical record
  numbers
  
• As defined under HIPAA Privacy Rule (dates,
  addresses, drivers license numbers, medical
  device identifiers, e-mail addresses, finger
  prints, voice prints, facial images, etc)
• Indirect identifiers
• Codes (unless all investigators access is
  prohibited)

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Examples of Engagement OHRP Guidance January
1999

• Releasing individually identifiable private
  information to investigators without permission
  
• Permission includes
• Written permission for medical records and other
  sensitive information
  
• Oral permission for contact information
• Prior Informed Consent or HIPAA Authorization

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Examples of Engagement OHRP Guidance January
1999

• Facilities housing cooperative research
  Operations Centers or Statistical Centers
  containing identifiable private information
  
• Facilities (grantees) receiving direct HHS awards
  for research, even where all research is
  performed by subcontractors
  
• Facilities housing research repositories
  containing identifiable private information

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Facilities HousingResearch 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 engaged in individual projects
  using repository data
  
• Unless PI is also at the facility)

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Consequences ofEngagement for VA Facilities

• Federalwide Assurance (FWA) needed
• Institutional Review Board (IRB) review and
  approval needed

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Critical QuestionIRB 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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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]