Office of Research Oversight

1. Office of Research Oversight VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Establishes procedures for determining whether a VHA operations activity constitutes research October 28, 2011

2. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Operations Activities – • Administrative, financial, legal, quality assurance, quality improvement, and public health endeavors that are necessary to support VHA’s missions of delivering health care to the nation’s Veterans, conducting research and development, performing medical education, and contributing to national emergency response. • Operations activities may or may notconstituteresearch.

3. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Research – • A systematic investigation designed to develop or contribute to generalizable knowledge. Generalizable Knowledge(for purposes of this Handbook) – • Information that expands the knowledge base of a scientific discipline or scholarly filed of study. • Thus, systematic investigations designed to produce information to expand the knowledge base of a scientific discipline or scholarly field of study constitute research.

4. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Operations Activities that ARE NOT Research – • Activities that are not designed to produce information that expands the knowledge base of a scientific discipline (or other scholarly field) do not constitute research. • An operations activity does not constitute research if both:  (1)The activity is designed and/or implemented for internal VA purposes (i.e., its findings are intended to be used by and within VA or by entities responsible for overseeing VA); and (2) The activity is not designed to produce information that expandsthe knowledge base of a scientific discipline (or other scholarly field).

5. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Examples of Non-Research Operations Activities – • Quality assessment and quality improvement activities designed for internal VA purposes, including routine data collection and analysis for operational monitoring, evaluation, and program improvement purposes (see Handbook §5b for multiple specific examples) • VHA system redesign activities, patient satisfaction surveys, case management and care coordination, policy and guideline development and related evaluation activities, benchmarking activities, etc. • Competence or qualification reviews of VA employees and health care professionals, provider and health plan performance evaluations; peer review; training and education; accreditation, licensing, and credentialing; Joint Commission visits and related activities.

6. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Examples of Non-Research Operations Activities – • Medical reviews, medical use evaluations (MUEs), legal analyses, auditing services, regulatory compliance programs, fraud and abuse detection, ORO reviews and investigation, Medical Inspector investigations and national assessments, OIG activities. • Business planning and development such as cost-management and planning analyses related to managing and operating an entity, business management and general administrative activities, and financial auditing. • Underwriting and similar activities

7. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Operations Activities that ARE Research – • Any activity whose conceptualization, plan, or implementation is supplemented or modified in order to produce information expanding the knowledge base of a scientific discipline or scholarly field of study. • Analyzing non-research data in a different way to produce information expanding the knowledge base of a scientific discipline or scholarly field of study. • Modifying or adding to a non-research activity to produce information expanding the knowledge base of a scientific discipline or scholarly field of study.

8. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Activities that ARE ALWAYS Research – • Activities funded or otherwise supported as research by ORD or any other entity. • Clinical investigations as defined under FDA regulations Activities that ARE ALMOST ALWAYS Research – • Activities using double blind interventions, placebo controls, and prospective patient-level randomization to clinical interventions not tailored to individual patient benefit

9. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH When in Doubt – Consult and Document • Depending on scope of project, consult relevant VHA Program Office, Network, or Facility • Obtain documentation from designated official in relevant VHA Program Office, Network, or Facility • If relevant VHA Program Office, Network, or Facility is uncertain, consult and obtain documentation from designated joint ORO/ORD workgroup Documentation = 1-page sample form on ORO website • Must be retained by project leader

10. VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Publication/Presentation Does Not Define Research – • Publication (or presentation) of findings from non-research operations activities does not itself constitute research. • Publication in peer-reviewed journals of findings from non-research activities requires documentation prior to publication by • Relevant VHA Program Office if funded, mandated, managed, sponsored, or supported by a VHA Program Office • Otherwise, designated Facility or Network official (depending on scope of project)