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Primary Care Faculty Development Fellowship Project Expectations / Introduction to IRB. 16 October 2010 Jon Temte, MD/PhD University of Wisconsin School of Medicine and Public Health Department of Family Medicine. Project Guidelines.

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primary care faculty development fellowship project expectations introduction to irb

Primary Care Faculty Development FellowshipProject Expectations / Introduction to IRB

16 October 2010

Jon Temte, MD/PhD

University of Wisconsin

School of Medicine and Public Health

Department of Family Medicine

project guidelines
Project Guidelines

Each Fellow is expected to prepare and present a project that integrates the skills learned during the Fellowship

  • Select a topic of interest from one of the core curriculum areas
  • Develop a question/identify problem, determine the feasibility of the investigation, define your audience.
project guidelines1
Project Guidelines
  • Discuss, discuss, discuss
  • Prepare your project plan
  • Complete IRB/HIPAA requirements
  • Complete your project
  • Write an abstract of your findings
  • Present your project/findings at the final session
    • April 1-2, 2011
typical projects
Typical Projects
  • Quality Improvement Project
    • Examining processes
    • making them more effective
  • Educational Project
    • Writing or revising a curriculum
  • Research Project
    • Systematic investigation of a question or theory
examples of projects
Examples of Projects
  • Conscientious Refusal in Family Medicine Residency Training
    • Jennifer Frank, MD, FAAFP
  • Needs Assessment of Residents Regarding Cultural Competency
    • Lisa Righter, MD
  • Evaluation of an Oral Health Intervention in a Primary Care Setting
    • Graciela Villadóniga, MD
  • Predictors of Postpartum Smoking Relapse
    • Troy Kleist, MD
examples of projects1
Examples of Projects
  • Review of the American Board of Internal Medicine Diabetes Performance Improvement Module
    • Jason Mohror, MD, FAAP
  • A Needs Assessment for Staff Training in Geriatric Rehabilitation
    • George Xakellis, MD and Nancy W. Patterson, BSN, MS
  • Improving Patient Flow and Satisfaction at the Center for Senior Health and Longevity
    • Soryal Soryal, MD
  • Comparison between Pharmacists and Physician Managed Anti-Coagulation Program
    • Imran Sajjad, MD
project timeline
Project Timeline
  • Decide on Project Type and Topic
    • November 12, 2010
  • Complete IRB/HIPAA trainings on line
    • December 17, 2010
  • Complete IRB process for your project
    • January 14, 2011
  • Complete data collection
    • February 25, 2011
project timeline cont
Project Timeline (cont.)
  • Submit draft abstract
    • March 4, 2011
  • Submit final abstract
    • March 18, 2011
  • Submit PowerPoint Presentation
    • March 25, 2011
  • Present Project
    • April 2, 2011
who is here to help
Who is Here to Help?
  • Fellowship Faculty and Staff
    • Jon Temte
    • Patricia Kokotailo
    • Mae Hla
    • Stephanie Berkson
    • Patricia Greene
  • HS-HSC Staff
  • Your colleagues
identifying an appropriate topic

Identifying an Appropriate Topic

Thinksmall... (or very small)

small, easily completed projects

set the stage for success

nine essential questions
Nine Essential Questions
  • What is the question ?
    • ask very simple questions...
  • Why is it interesting ?
    • is the questions clinically relevant ?
    • is there fire in your belly ?
  • Has the question been answered by somebody else?
    • literature review, discussions with “experts”
nine essential questions cont
Nine Essential Questions(cont.)
  • Can the project be done during very limited time ?
    • limited time, other competing demands
  • What data will you need ?
    • keep it simple, narrow hypotheses
  • How will you collect the data ?
    • chart reviews, simple prospective designs
nine essential questions cont1
Nine Essential Questions(cont.)
  • How will the data be used to answer the question ?
    • research design, statistics, analyses
  • What help will you need ?
    • mentorship, data collection and entry
    • analyses, interpretation, writing, review
  • Can you find the help you need ?
    • support staff, faculty mentors, statisticians
a question of risk a stepwise approach
A question of Riska stepwise approach
  • Identify the potential harms posed by the proposed intervention
  • Categorize the magnitude of the potential harms
    • 7 continuous levels on a “harm” scale
  • Estimate the likelihood of each potential harm
  • Compare likelihoods of each harms against a comparator activity

Rid et al., Evaluating the risks of clinical research. JAMA 2010 304:1472-9.

overview of irb process
Overview of IRB Process
  • Purpose is to provide a systematic way to protect human subjects involved in research
  • The Health Sciences Human Subject Committee serves the Medical School and consists of representatives from Law Medicine, Pediatrics, Psychiatry and others
    • “Health Sciences Institutional Review Boards”
    • http://www.medicine.wisc.edu/hsc/
the big question
The Big Question
  • Will your project need IRB review?
    • ONLY the IRB can make this determination
    • Depends on the institution where the study will be conducted
  • Remember HIPAA when planning your project
    • “HIPAA Privacy Rule Research Guidance”
    • www.wisc.edu/hipaa/ResearchGuide/index.html
slide18
All Fellowship participants should complete the IRB and HIPAA Trainings
  • IRB Human Subjects Protections Tutorial:

https://my.gradsch.wisc.edu/citi

  • HIPPA Training:

https://hipaa.wisc.edu/courses/moodle/login/index.php

where to go from here
Where to Go From Here
  • Talk with Fellowship faculty, staff and your colleagues about your project ideas
  • Begin to formulate your project using the planning handouts provided
  • Complete the IRB and HIPAA Trainings
  • Contact Patricia Greene or one of the HS-HSC staff with IRB/HIPAA-related questions
looking ahead
Looking Ahead
  • Prior to the November session, you will be assigned a mentor based on your initial project ideas
  • A staff person from the HS-HSC will participate in our November project time
  • By our January meeting you should have completed your IRB review and began data collection