Bruce Manzo, Pharm.D. 10/18/2012 Fresno VA. Embarking on an IRB approved submission can be a lengthy process….. ◦ (pre)Plan accordingly! Researchers.

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

Successful PGY1 Residency Projects

without an IRBMargaret Chrymko

Erie VAMCOctober 2012

VHA Handbook 1058.05

ASHP Outcomes, Goals, Objectives

RESIDENCY PROJECT

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

FOR YOUR OWN FACILITY

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

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

Proposal

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

VHA Handbook 1058.05

ASHP Outcomes, Goals, Objectives

RESIDENCY PROJECT

VHA Handbook 1058.05 VA Directive 6511 ASHP PGY1 Pharmacy Residency Outcomes,

Goals, Objectives, Criteria

References