bruce manzo, pharm.d. 10/18/2012 fresno va. embarking on an irb approved submission can be a...
TRANSCRIPT
Research Tips for Pharmacy Residencies….Preparing a project for your local IRB.
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
http://www.research.va.gov/pride/policy/#
VA and Research
Regulations generally enforced by:◦ Office of Research Oversight◦ VA Office of the Inspector General◦ Alion Science and Technology Corporation◦ FDA
VA and Research
The Director of the Facility is ultimately responsible for the conduct and adherence of the facility’s Human Research Protection Program to the regulations…..
VA and Research
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)
Initial Steps to preparing for IRB
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
Initial Steps to preparing for IRB
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
Initial Steps to preparing for IRB
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.
Initial Steps to preparing for IRB
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?
What we have learned from the IRB
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
What we have learned from the IRB
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…
What we have learned from the IRB
Protocol development◦ One of the biggest issues we have faced has been
passing the “So What?” test…◦ FINER:
Feasibility Interesting Novel Ethical Relevant
What we have learned from the IRB
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
What we have learned from the IRB
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
What we have learned from the IRB
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…..
What we have learned from the IRB
Non-Research Operations ActivitesOperations 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
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).
Examples of Non-Research Operations Activities cont’d
Systems redesign activitiesPatient satisfaction surveysCase management and care coordinationPolicy and guideline development and
related evaluation activitiesBenchmarking activities/comparisonsRoot cause analysesMedication use evaluationsBusiness 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
Consultation and Documentation
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
Publication and Presentation
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
PGY1 Residency Requirement
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
Criteria for Project Management (PGY1)
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
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
Criteria cont’d
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
Possible Ideas
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
TIPS
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
Design
Background Objective(s) Methodology Analysis—can use statistics------------------------- Results Discussion Conclusions
AVOID the temptation to generalize
Manuscript
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
READ, READ, READ