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Human Subject Protection Issues for HSR&D Researchers Tom Puglisi, PhD, CIP Chief Research Oversight Officer HSR&D National Meeting February 21-23, 2007. Office of Research Oversight. Research vs Quality Improvement Research vs Program Evaluation Compartmentalizing Project Activities

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Office of research oversight l.jpg

Human Subject Protection Issues for HSR&D Researchers

Tom Puglisi, PhD, CIP

Chief Research Oversight Officer

HSR&D National Meeting

February 21-23, 2007

Office of Research Oversight

Frequent problem areas in hsr d research l.jpg

Research vs Quality Improvement

Research vs Program Evaluation

Compartmentalizing Project Activities

Patients and Providers as Subjects

Information Security


Frequent Problem Areasin HSR&D Research

Definition of research 38 cfr 16 102 d l.jpg

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

Definition of Research38 CFR 16.102(d)

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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

Research vsQuality Improvement

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Independence of the Program Under Evaluation generalizable knowledge

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

Research vsProgram Evaluation

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generalizable knowledgeThe 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

CompartmentalizingProject Activities

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Subjects may feel “undue influence” to participate generalizable knowledge

Confidentiality risks are real

Harm may be substantial

Patients and Providersas Research Subjects

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Anonymous vs generalizable knowledge

Not Identifiable



VA Security Requirements




Information Security

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Federal Policy (Common Rule) generalizable knowledge

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.

“Engagement” in Research

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Federalwide Assurance (FWA) is REQUIRED generalizable knowledge

Institutional Review Board (IRB) review and approval are USUALLY (but not always) REQUIRED

General Consequences ofEngagement

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A VA generalizable knowledgefacility 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-identifiable private information (or individually-identifiable specimens) for research purposes

See 38 CFR 16.102(f)

Engagement in Human ResearchVHA Handbook 1200.5 § 3.b.

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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

VA Facilities Housing Research Repositories

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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?

Critical Question: IRB Review byNon-Engaged VA Facilities

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Examples of HSR&D Research “non-facility” researchers?

Definition of Research38 CFR 16.102(d)

Office of research oversight15 l.jpg “non-facility” researchers?

811 Vermont Avenue, N.W., Suite 574 (10R)

Washington, D.C. 20420

PHONE: (202) 565-5184

FAX: (202) 565-9194

Office of Research Oversight