Research Tips for Pharmacy Residencies….Preparing a
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Transcript Research Tips for Pharmacy Residencies….Preparing a
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/#
Regulations generally enforced by:
◦
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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)
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
RESIDENCY PROJECT
VHA
Handbook
1058.05
ASHP Outcomes,
Goals, Objectives
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/costmanagement/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 agreedupon 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 1058.05
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 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
RESIDENCY PROJECT
VHA
Handbook
1058.05
ASHP Outcomes,
Goals, Objectives
VHA Handbook 1058.05
VA Directive 6511
ASHP PGY1 Pharmacy Residency Outcomes,
Goals, Objectives, Criteria