Primary Care Faculty Development Fellowship Project Expectations / Introduction to IRB

1. 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

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 Thinksmall... (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 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.

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