1. Office of Research Oversight VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Establishes standards and procedures for determining whether a VHA operations activity constitutes research October 22, 2015 Handbook Dated October 28, 2011

2. VETERANS HEALTH ADMINISTRATION 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 not constitute research. 1

3. VETERANS HEALTH ADMINISTRATION 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 field 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. 2

4. VETERANS HEALTH ADMINISTRATION 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 expands the knowledge base of a scientific discipline (or other scholarly field). 3

5. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Methodology (scientific “design”) Non-research operations activities must use scientifically sound methodology to ensure reliable outcomes to fulfill program requirements Methodology itself does not define research Critical question = why was the methodology used? Solely to fulfill operations need = non-research Contribute to generalizable knowledge = to expand the knowledge base of a discipline = research Publication and Presentation of Findings DO NOT Themselves Define Research 4

6. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Examples of Non-Research Operations Activities – Quality assessment and quality improvement activities designed solely for internal VA purposes Routine data collection and analysis for Internal VA operational monitoring, Internal VA evaluation, and Internal VA program improvement VA Customer Satisfaction Surveys *Additional examples are provided at end of this presentation 5

7. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Activities that ARE ALWAYS Research – Activities funded or otherwise supported as research by the Office of Research & Development (ORD) or any other entity (eg, National Institutes of Health, National Science Foundation). Clinical investigations as defined under Food and Drug Administration (FDA) regulations 6

8. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Activities that ARE ALMOST ALWAYS Research – Activities using: Double blind interventions Placebo controls Prospective patient-level randomization to clinical interventions not tailored to individual patient benefit 7

9. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Operations Activities that Become Research – Any operations 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. Modifying or adding to an existing non-research activity 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. 8

10. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Use of Operations Data for Research Data collected for non-research operations may subsequently be accessed and used for research If such data are accessed and analyzed differently in order to expand the knowledge base of a discipline (ie, contribute to generalizable knowledge), then this access and use constitutes research. An activity designed as non-research operations becomes research if supplemented or modified in order to expand the knowledge base of a discipline. 9

11. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH When in doubt, CONSULT and DOCUMENT Program Office = Activities funded, mandated, managed, sponsored, or otherwise supported by a VHA Program Office (eg, Academic Affiliations, Patient Care Services, Research & Development) or that use Program Office data (see ORO Website for Program Office Designees) Director or designee = Non-Program Office activities conducted at the Facility Level Network Director or designee = Non-Program Office activities conducted at the Network Level ORO/ORD = Any activities where there is doubt 10

12. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Documentation Requirements 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 or using Program Office data (see ORO website) – Otherwise, designated Facility or Network official (depending on scope of project) 11

13. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Documentation Requirements Specific format and requirements may vary by sponsoring VA Program Office Publication in non-peer-reviewed journals and professional presentations of findings from non-research activities do not REQUIRE documentation prior to publication or presentation Documentation is strongly encouraged whenever there may be doubt or misunderstanding about the nature of the activity * A sample documentation format is provided at end of this presentation and on the ORO website 12

14. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Information, Program Office Designees, Sample Documents – http://www.va.gov/ORO/oropubs.asp http://www.va.gov/ORO/oropubs.asp Questions, Problems, Assistance – Office of Research Oversight (10R) Research Compliance & Education Program (RCEP) ORORCEP@va.gov Office of Research & Development (10P9) 13

15. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - Sample Format for Documentation of Non-Research Activities 14 Title of Proposed Publication: Author Attestation As an author of the publication referenced above (copy attached), I attest that the findings reported in the publication were not derived, in whole or in part, from activities constituting research as described in VHA Handbook 1058.05. Provide for each VA Author and Co-Author Author Signature:Date: Author Name:VA Duty Station: Signature of Designated Official:Date: Name Title: Program Office or Facility: Note: Each VA author and coauthor must retain a copy of the documentation for a minimum of 5 years after publication and in accordance with any applicable records retention schedules.

16. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Additional 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 Specific QA/QI examples provided in §5b: VA All Employee Survey (AES), Voice of VA Survey, etc. Cardiac Assessment Reporting and Tracking System (CART) External Peer Review Program (EPRP) Home and Community Based Quality Care Initiative 15

17. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Additional Examples of Non-Research Operations Activities – Specific QA/QI examples provided in §5b (continued): Inpatient Evaluation Center (IPEC) Mental Health Program Evaluation Centers National Center on Homelessness Among Veterans Office of Suicide Prevention System-wide Ongoing Assessment and Review Strategy (SOARS) VA Surgical Quality Improvement Program (VASQIP) VHA Quality Improvement Initiative (VQuIP) Public Health Investigations 16

18. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Additional Examples of Non-Research Operations Activities – 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. 17

19. VETERANS HEALTH ADMINISTRATION VHA Handbook 1058.05 - VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Additional 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 18