Bruce Manzo, Pharm.D. 10/18/2012 Fresno VA

 Embarking on an IRB approved submission can be a lengthy process….. ◦ (pre)Plan accordingly!  Researchers should be aware of the policies and procedures of the VA: ◦ Handbooks ◦ Directives ◦ Federal Regulations 

 Regulations generally enforced by: ◦ Office of Research Oversight ◦ VA Office of the Inspector General ◦ Alion Science and Technology Corporation ◦ FDA

 The Director of the Facility is ultimately responsible for the conduct and adherence of the facility’s Human Research Protection Program to the regulations…..

 What are your pharmacy resources? ◦ Who sits on your research committees from pharmacy? ◦ Books and other tertiary material ◦ Internal mentoring.  Do you have colleagues at other facilities that can mentor you if no internal mentoring is available? ◦ HERC training (may be more appropriate for your preceptors than residents) HERC training

 What are your facility resources external to pharmacy? ◦ Who are the contacts in your research department?  Who is the ACOS for research?  Do you have a statistician available to consult?  Who sits on the IRB for your facility? ◦ Mentoring programs ◦ Training workshops for your residents

 Primary Investigator ◦ New programs may not have a lot of experience  Residency trained preceptors are a start… ◦ Collaborate with your ACOS/R ◦ If no one in the pharmacy is available, is there an experienced PI in the facility who can mentor?  Commitment  Reponsibility  Access

 Is the protocol determined to be research? ◦ VA Definition: Research means a systematic investigation including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge. ◦ Discuss the protocol with the research department. ◦ Do not make this determination on your own. ◦ Include the intent of presentation of the results of the protocol.

 Protocol development ◦ The most important step to understanding how the IRB works is to submit a protocol.  Experience counts!  Being a member of the IRB may help….  Being a member of the R&D may help…  Share the work with a fellow preceptor?

 Protocol development ◦ Paperwork  Needless to say, the paperwork for an IRB submission is lengthy and may be difficult to interpret  Training certs  Updated CV  Your Research Administrative officer or other Research office personnel  May have insight on specific language needed for the application  Can help to determine if the protocol qualifies for a consent waiver

 Protocol development ◦ What is the objective of the project in the simplest, most specific possible terms?  Should people use fish oil?  Does treatment with fish oil capsules reduce total mortality in people with CHD? ◦ Be clear about the null hypothesis or alternative hypothesis…

 Protocol development ◦ One of the biggest issues we have faced has been passing the “So What?” test… ◦ FINER:  Feasibility  Interesting  Novel  Ethical  Relevant

 Protocol development ◦ Designing the study  Grand ideas can be broken into more manageable pieces  The design should be both achievable and able to provide a valid answer to the study question and applicability to a broader population  More endpoints require more justification  Collect the smallest amount of data to answer the question

 Protocol development ◦ Statistical analysis  Paying attention to detail in the protocol saves time in review.  Two statisticians may not always agree  plan to have your statistician available during protocol reviews

 Protocol development ◦ Pitfalls  Poor planning and follow up with the research team/resident  Are you studying something that isn’t in place yet?  Are you planning on using tools that require specialized training?  Retrospective/Cohort versus Prospective  Our IRB was concerned about collecting individual provider data for a project…..

Margaret Chrymko Erie VAMC October 2012

VHA Handbook ASHP Outcomes, Goals, Objectives RESIDENCY PROJECT

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 expands the knowledge base of a discipline

 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).

 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

 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

 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

 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

 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

 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

 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

 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

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

 Background  Hypothesis  Objective(s)  Methodology  Analysis—can use statistics

 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

 Background  Objective(s)  Methodology  Analysis—can use statistics  Results  Discussion  Conclusions AVOID the temptation to generalize

 VHA Handbook  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

VHA Handbook ASHP Outcomes, Goals, Objectives RESIDENCY PROJECT

 VHA Handbook  VA Directive 6511  ASHP PGY1 Pharmacy Residency Outcomes, Goals, Objectives, Criteria