Transcript Informed Consent & HIPAA

CASE STUDY:
Managing Multi -Disciplinary Research
C a r o l H u t s ko , B B A
SARA, B1
Robin Sedman, MSN, M.Ed
SARA, A2
G w e n d o l y n Yo u n g , M B A
SARA, A1
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.
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).
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.
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.
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.
Questions?