Risk Factors of Stroke among University of Alaska Anchorage Female Students

Office of the UVU IRB
December 3, 2013
APPLICATION FOR APPROVAL FOR THE USE OF
HUMAN SUBJECTS IN RESEARCH
Date Submitted to the IRB: IRB Tracking # (To be assigned by IRB):
A. PROJECT AND RESEARCH IDENTIFICATION
1. Proposed Title of Study:
Risk Factors of Stroke among University of Alaska Anchorage Female Students
2. Principal Investigator: Must be CITI Certified
Name:
Principal Investigator’s UVU Status: Faculty Staff Student Other
Department Affiliation:
Mail Code: Phone #: E-mail:
3. Co-Investigator(s)(if applicable): Must be CITI Certified
Name:
Co-Investigator’s UVU Status: Faculty Staff Student Other
Department Affiliation:
Mail Code: Phone #: E-mail:
Name:
Co-Investigator’s UVU Status: Faculty Staff Student Other
Department Affiliation:
Mail Code: Phone #: E-mail:
4. Student Researcher(s) (if applicable): Must be CITI Certified
Investigators’ Information: A student may be a Principal Investigator (PI) if a faculty or staff advisor is the
co-investigator. The faculty or staff advisor is responsible to ensure the ethical conduct of the research.
If the PI is not a UVU employee, the PI must obtain the approval of the department chair or director of the
discipline of the proposed research.
5. List any other individuals who will assist or view data, including name, phone number, and e-mail.
Must be CITI Certified
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Office of the UVU IRB
December 3, 2013
B. PROJECT SPONSORS
1. How will this research be funded (Check all that apply)?
Internal department funds Federal Grant/Contract
Non-funded research Corporate Sponsor or Private Foundation
Other
Please describe if funding is from a Federal Grant/Contract, Corporate Sponsor, Private Foundation,
or Other source.
The funding will be expected through segmented process that will be executed on monthly basis.
C. RESEARCH INFORMATION
1. Abstract/Summary:
NOTE: Use language understandable to a person unfamiliar with your area of research. Include the
justification, purpose, research questions, or hypothesis.
Stroke has become one of the most common life threatening occurrences across the globe,
where the majority number of people is female. The mission of this research is to explore
the major causes that lead to the mild and sever stroke in female population. The primary
goal of this research is identifying Alaskan college age females as a group at higher risk for
ischemic stroke, in comparison to the national average for that age group, by looking at
physical risk factors and blood tests.
2. Describe the research methods to be used (e.g., measures, instrumentation, procedures for
distribution and data collection, plans for minimizing risks to subjects,data analysis procedures, if
applicable, etc.):
For this research survey and medical diagnosis will be used as data collection procedure.
The smoking tendency, consumption of Birth Control pill, stress level and other similar
information will be collected trough survey questionnaire. The BMI test, hight-weigh
measurement, Blood pressure measurement, blood collection for sodium citrate-
coagulation and heparin tube-lipid panel will be used as medical diagnosis based data
collection techniques.
3. Describe the tasks participants will be asked to complete and approximately how long the participant
will be involved in the research (e.g., number of hours, days, months, etc.).
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Office of the UVU IRB
December 3, 2013
The initial data collection procedure that will involve the participants will take one week,
whereas the overall project will take approximately 2 month.
4. DURATION of study(Duration should cover a period of time sufficient for both data collection and
data analysis.):
FROM:1/12/18 TO:15/1/19
NOTE: By federal regulations, ongoing research protocols (multiple-year studies) must bereviewedat
least annuallyby the IRB. The PI should report the end of the research project to the IRB.
For expedited and full-board reviewed studies, the PI must file a Close Out form with the IRB.
Research conducted after the termination will not be considered approved by the IRB and willbe in
violation of policy and federal regulations.
5. Is this a multi-center study?
YES NO
a. If YES, please list other institutions participating and attach a page that explains the
responsibilities and obligations of each center and/or each investigator. Designate which
institution is the primary institution.
b. If YES, has this study been, or will it be, reviewed by another IRB?
YES NO
c. If YES (to 5b), give name and address of the Board and date of review:
D. DESCRIPTION OF HUMAN SUBJECT AND RECRUITMENT PROCEDURES
1. Subjects:
a. Who will be the human subjects (be specific)?
Female students of University of Alaska Anchorage will be the sample population or human subject for this
study
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