primary care faculty development fellowship project expectations / introduction to irb 16 october...
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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
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 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
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
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 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
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.)
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?
Fellowship Faculty and Staff Jon Temte Patricia Kokotailo Mae Hla Stephanie Berkson Patricia Greene
HS-HSC Staff Your colleagues
Projects during Practice
Pearls
Identifying an Appropriate Topic
Think small... (or very small)
small, easily completed projects set the stage for success
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.)
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 (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 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
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
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
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
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
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
