Should the PIs need an extension beyond the proposed duration, they can
apply by completing the Continuance Request Form.
2)
If this research will result in a thesis or dissertation, please check the appropriate box.
Undergraduate Level Project
Masters Level Project
Doctoral Level Project
(Thesis, Capstone)
(Thesis, Capstone)
(Dissertation, Capstone)
3)
Conflict of Interest
Is there any potential or perceived conflict of interest between the researcher, sponsor and/or
South University associated with this study?
No
Yes
***If yes, please explain, including any and all possible conflicts:
4)
Study population
a.
Maximum Number of Participants Proposed:
60
b.
Age Range:
35
to
65
(include low/high age range)
c.
Gender:
Males
Females
d.
Site of Subject Recruitment: Cardiology office in the state of Florida
***Please note that if recruitment will be conducted at any physical site other than South University,
you will need to include a letter from management of the proposed site indicating their approval of
your use of the facility.
e.
Will medical clearance or medical screening be necessary for participants to
participate because of tissue or blood sampling, administration of substances such as
food or drugs, or physical exercise conditioning?
No
Yes
***If yes, explain how clearance will be obtained.
If a screening instrument will be used, please
attach a copy to the application.
Page 6 of 16
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS
ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101
.
5)
Potentially Vulnerable Populations.
Please check any groups included in the study.
Children (under 18 years of age)
Pregnant Women
Elderly (65 & older)
Psychologically Impaired
Cognitively Impaired
Prisoners
Native American Tribes and/or Tribal
Organizations
Students currently enrolled in a class
instructed by the
investigator
*** If you checked any of the above groups, your proposal will require full board review.
6)
Study Site: Cardiology offices involved
***Please note that if research will be conducted at any physical site other than South University, you
will need to include a letter from management of the proposed site indicating their approval of your
use of the facility.
PART VI – SUMMARY OF STUDY ACTIVITIES
***Submission of a copy of a grant application or project proposal does not replace completion of
this form.
If additional space is required, you may attach a separate document, but please respond to
each item in this section and label your responses accordingly. Incomplete proposals will be returned
to you.
1)
Provide background information for the study including the objective of the proposed
research, purpose, research question, hypothesis and other information deemed relevant.
Myocardial infarctions and other cardiovascular related events are the leading cause of death in the United
States (Van Dyke, 2018). The purpose of this study is to determine if patients who receive continued
communication with the nurse practitioner about their cardiac rehab treatment plan exhibit a decrease in
risk of a subsequent MI within the first year of the initial MI.
