Successful PGY1 Residency Projects without an IRB

1. Successful PGY1 Residency Projects without an IRB Margaret Chrymko Erie VAMC October 2012

2. RESIDENCY PROJECT VHA Handbook 1058.05 ASHP Outcomes, Goals, Objectives

3. Non-Research Operations Activites Operations Activities that ARE NOT Research –  (1)The activity is designed and/or implemented for internal VA purposes (i.e., findings are intended to be used by and within VA); AND (2) The activity is not designed to produce information that expandsthe knowledge base of a discipline

4. 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. Examples: • All Employee Surveys, Voice of VA Surveys, etc. • External Peer Review Program (EPRP); • System-wide Ongoing Assessment and Review Strategy (SOARS); • VHA Quality Improvement Initiative (VQuIP).

5. Examples of Non-Research Operations Activities cont’d • Systems redesign activities • Patient satisfaction surveys • Case management and care coordination • Policy and guideline development and related evaluation activities • Benchmarking activities/comparisons • Root cause analyses • Medication use evaluations • Business planning/development/cost- management/planning analyses related to managing and operating an entity

6. Consultation and Documentation • Consult supervisor and document ASAP whenever there may be doubt about the research versus non-research status • If doubt, consult the relevant Program Office, VHA Network, or VHA facility • Documentation prior to initiation of the activity is strongly encouraged when patients will not be fully informed of the reasons for treatment recommendations or assignments to specific treatments or when publication of findings from operations activities outside VA is reasonably anticipated

7. Publication and Presentation • Publication and Presentation Do Not Define Research. • Publication or presentation outside VA of findings from non-research operations activities or other non-research activities does not, in and of itself, constitute research • Requires documentation of the non-research status of the activities by the relevant Program Office prior to publication •  Consult Handbook for specifics

8. PGY1 Residency Requirement • Outcome: Demonstrate project management skills • Goal: Conduct practice-related investigations using effective project management skills • (OBJ) Initiate, design, implement, and write up a practice-related investigation which, at all steps in the process, reflects the skillful application of project management skills

9. Criteria for Project Management (PGY1) • Choice of project is practice-related • Choice of project warrants investigation • Project can be completed in time available • Project proposal contains all customary elements of a proposal • Each proposal element contains all necessary information

10. Criteria cont’d • Project proposal includes identification of all key stakeholders who must approve • Appropriate strategies designed and implemented for gaining cooperation of all individuals affected by conduct of the project • Project timeline milestones, if adhered to, would result in project completion by agreed-upon date • Project completed on time

11. Criteria cont’d • During conduct of project, project materials well-maintained for accessibility and efficient retrieval • Project process appropriately documented • Project materials well organized and maintained with documentation of the project’s ongoing implementation • Project presentation utilizes appropriate manuscript style and meets criteria for writing with use of that style

12. Possible Ideas • Evaluate a service, part of a service • Evaluate changes in a service • Evaluate equipment, cost, time savings • Evaluate effectiveness of a change, i.e. a reminder • Assess impact of PACT on XYZ • MUE • Other process improvement or medication safety • Evaluate antibiotic stewardship outcomes • Ask other team members

13. FOR YOUR OWN FACILITY

14. TIPS • LIMIT the size of the project • Take this responsibility seriously • Set a timeline/deadlines for sections • Educate on requirements, including VHA Handbook 1058.05 • Provide examples • Discuss expectations • Submit proposals to designated authority for approval as non-research—DO NOT decide yourself

15. Proposal • Background • Hypothesis • Objective(s) • Methodology • Analysis—can use statistics

16. Design • Sound design characteristics do not, in and of themselves, define research • consider carefully whether design characteristics are included for the purpose of fulfilling operational needs versus expanding the knowledge base of a discipline

17. Manuscript • Background • Objective(s) • Methodology • Analysis—can use statistics ------------------------- • Results • Discussion • Conclusions AVOID the temptation to generalize

18. READ, READ, READ • VHA Handbook 1058.05 • VA Directive 6511-Presentations Displaying Personally-Identifiable Information (Form 0897)-contact Privacy Officer • ASHP Standards • ASHP Outcomes, Goals, Objectives, Criteria • Who needs to read these? • Chief, supervisors, residency program director, project advisor AND RESIDENT

19. RESIDENCY PROJECT VHA Handbook 1058.05 ASHP Outcomes, Goals, Objectives

20. References • VHA Handbook 1058.05 • VA Directive 6511 • ASHP PGY1 Pharmacy Residency Outcomes, Goals, Objectives, Criteria