1. Carol Hutsko, BBA SARA, B1 Robin Sedman, MSN, M.Ed SARA, A2 Gwendolyn Young, MBA SARA, A1 CASE STUDY: Managing Multi-Disciplinary Research

2. Dr. Adam, a physician at UMHS in the Division of Infectious Disease, is planning a research project to improve the ability to diagnose Lyme Disease. Lyme Disease is caused by the bacterium and is transmitted to humans through the bite of infected blacklegged ticks. Typical symptoms include: Fever, Headache, Fatigue, And, a characteristic skin rash called erythema migrans. Lyme Disease is diagnosed based on symptoms, physical findings (e.g., rash), and the possibility of exposure to infected ticks; laboratory testing is helpful if used correctly and performed with validated methods.

3. As part of Dr. Adam’s research project on improving the ability to diagnose Lyme Disease. Dr. Adam plans to:  Review the existing medical records of patients with Lyme Disease  Conduct non-invasive follow-up exams with the subjects  Have subjects complete short questionnaires related to their condition The project has received funding from the National Institutes of Health (NIH).

4. On his IRBMED application, Dr. Adam lists his colleague, Dr. Betty, to serve as Co-Investigator (CoI). Dr. Betty, a PhD prepared Immunologist at UMHS, is interested in this effort as it may inform development of a vaccine for Lyme Disease. Dr. Adam also hires a Clinical Research Nurse, Carl, and a Research Coordinator, Darlene.

5. Dr. Elroy, a biostatistician at the School of Public Health, is also listed on the IRBMED application. Dr. Adam will share identifiable subject data with Dr. Elroy for his analysis.

6. Following IRB approval, Dr. Adam reads a case study about two patients suffering from Lyme Disease. The case study is authored by Dr. Fran, a physician who works at Great Hope Institute (GHI), a non-academic medical facility. GHI does not have an IRB. Dr. Adam would like to amend his project to include Dr. Fran and recruit subjects with Lyme Disease from GHI.

7. Questions?