1. 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

2. 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.

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Who is Here to Help? Fellowship Faculty and Staff Jon Temte Patricia Kokotailo Mae Hla Stephanie Berkson Patricia Greene HS-HSC Staff Your colleagues

10. Projects during Practice Pearls

11. Identifying an Appropriate Topic T h i n k small... (or very small) small, easily completed projects set the stage for success

12. 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”

13. 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

14. 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

15. A question of Risk a 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.

16. 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/

17. 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

18. 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

19. 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

20. 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