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Human Subject Protection Issues for HSR&D Researchers

Tom Puglisi, PhD, CIPChief Research Oversight Officer

HSR&D National MeetingFebruary 21-23, 2007

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Frequent Problem AreasFrequent Problem Areasin HSR&D Researchin HSR&D 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 ResearchDefinition 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 vsResearch vsQuality ImprovementQuality Improvement

• Research is “designed” to develop or contribute to generalizable knowledge

• “Design” => plan / methodology• “Design” => intention

─ Prospective intention to conduct research─ Post Hoc intention to conduct research

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Research vsResearch vsProgram EvaluationProgram 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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CompartmentalizingCompartmentalizingProject ActivitiesProject 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 ProvidersPatients and Providersas Research Subjectsas Research Subjects

• Subjects may feel “undue influence” to participate

• Confidentiality risks are real• Harm may be substantial

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Information SecurityInformation Security

• Anonymous vs─ Not Identifiable─ De-identified ─ Coded

• VA Security Requirements─ Storage─ Transmission─ Encryption

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““Engagement” in ResearchEngagement” 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 ofGeneral Consequences ofEngagementEngagement

• 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 ResearchEngagement 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 individualsfor research purposes, or

• Obtain, release, or access individually-identifiable private information (or individually-identifiable specimens) for research purposes

– See 38 CFR 16.102(f)

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VA Facilities Housing VA Facilities Housing Research RepositoriesResearch 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 Facility’s IRB typically

not required unless PI is also at the facility

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Critical Question: IRB Review byCritical Question: IRB Review byNon-Engaged VA FacilitiesNon-Engaged VA Facilities

When is the VA facility “responsible” for activities of “non-facility” researchers?

• Involving the facility’s “patients” but conducted outside the facility?

• Involving the facility’s employees but conducted outside the facility?

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Definition of ResearchDefinition of Research38 CFR 16.102(d)

Examples of HSR&D Research

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Office of Research OversightOffice of Research Oversight

http://www1.va.gov/oro/ 811 Vermont Avenue, N.W., Suite 574 (10R)

Washington, D.C. 20420PHONE: (202) 565-5184

FAX: (202) 565-9194