Risk Factors of Stroke among University of Alaska Anchorage Female Students

This is an application for approval for the use of human subjects in research for the Risk Factors of Stroke among University of Alaska Anchorage Female Students. The research aims to explore the major causes that lead to the mild and severe stroke in female population. The data collection procedure will involve survey and medical diagnosis. The research will be funded through segmented process that will be executed on monthly basis. The research will be conducted from 1/12/18 to 15/1/19.

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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Office of the UVU IRB
December 3, 2013
b. Number of subjects:
Male: Female:30 TOTAL:30
c. Age Range: Check all that apply
0-7 (submit parental consent form)
8-17 (submit child’s assent form, parental consent form)
18-65 (Consent document must contain the following statement: “Individuals must be 18 years
of age or older to participate.”)
d. Location of subjects during research data collection:
University premises of University of Alaska Anchorage
e. Vulnerability of Subjects: (If YES on any of the below, you must explain the rationale for
selecting vulnerable subjects below.)
1) Are the subjects younger than 18 years of age? YES NO
2) Are the subjects older than 65 years of age? YES NO
3) Are the subjects cognitively impaired? YES NO
4) Are the subjects physically and/or mentally incapable of providing informed consent?
YES NO
5) Are the subjects potentially pregnant? YES NO
6) Are the subjects prisoners? YES NO
7) Are the subjects institutionalized? YES NO
8) Are the subjects at risk of coercion (e.g., your students)? YES NO
f. If the research involves any of the groups listed above, please check one of the following:
Use of such subjects is a necessary part of the research.
Such subjects may be included incidentally as members of a more general population.
Please explain the rationale for inclusion of vulnerable subjects.
The reseach wil find the relation between birth control pill consumption and the risk of strok within the
sample population of collage student of alaska. Therefore, the population will consist of pregnant woment
and even psychiatric paitents.
g. By federal regulation, subjects cannot be excluded from research on the basis of race, sex, age,
and languageor disability status. If research requires the exclusion of subjects, please explain:
This research is based on the strok rate in female population. Therefore the male population will be excluded.
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Office of the UVU IRB
December 3, 2013
h. Does this study potentially involve subjects (or parents or guardians) who are not fluent in
English? YES NO
NOTE: If YES, please submit both the English consent form and translation in the appropriate
language(s). Participants who are not fluent in English must have the consent form written in
and/or read to them in their native language, they must sign a form indicating that the informed
consent has been explained to them, and that all questions regarding it have been answered, in
their native language.
Recruitment: Explain how subjects will be recruited (e.g., advertisement, individual referrals, random
selection, etc.).
1.
Random selection
2. Compensation: Will the subjects be compensated in any way (e.g., extra credit, money, coupon, gift
certificate, etc.)? YES NO
If YES, please explain (including any tax or other regulatory impacts).
E. RISKS AND BENEFITS OF THE RESEARCH
1. What are the potential benefits to the subjects and/or to generalized knowledge to be gained from the
study?
Through this research, the practical cause of stroke in female population in Alaska can be identified. This
research can develop practical concept map of cause of effect of stroke causing factors with supportive
evidences, which can seek more attention from the authority for taking enough initiations and awareness
programs against the unhealthy lifestyles within the majority of population.
2. What are the risks to the subject(s) and what measures will be taken to minimize the risks?
For blood sampling experienced and profational member of the project team will be involved
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Office of the UVU IRB
December 3, 2013
F. INFORMED CONSENT
1. What method will be used to obtain informed consent (e.g., consent letter/form, script for phone
interview, parental form, child assent, etc.), by whom will it be obtained (PI, student researcher,
professor),and where will it be obtained (in-person, by phone, in a classroom, in the workplace)?
Pre survey aknowladgement paper will be used to ensure the agreement of perticipents and the research will be
reviewd by PI
G. CONFIDENTIALITY OF DATA
1. Anonymity of Subjects:Will the research subjects be identifiable to the researchers?
YES NO
2. Interaction/Intervention:Does the researcher or the researcher’s representative interact or
intervenewith subjects to obtain the data? YES NO
3. Confidentiality:What measures will be taken to ensure participants’ confidentiality in data collection,
if applicable, and in resulting publication and/or presentation?
The data of the survey will be stored in a computer harddisk with specific authentication system accesable only
for the research purposes.
4. Security of Data: How will data/documents be secured? Who will have access to the
data/documents?
The authority and the research team will have the access on the data.
5. Data Collection:Will data from voice, video, digital, or image recordings be made?
YES NO
6. Retention of Personal Identity Records:How long will personallyidentifying information (if any) be
kept before being destroyed?
7. Secondary Research Subjects:
a. Will the investigator be asking about individuals other than those from whom informed consent
has been received? YES NO
b. If YES, can these people be identified (e.g., asking a parent about a child’s behavior or a spouse
about the other spouse)? YES NO
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Office of the UVU IRB
December 3, 2013
c. If “YES”, please explain.
H. EXISTING DATA AND INTENT TO PUBLISH OR PRESENT
1. Existing Data
a. Has the data already been collected for another purpose? YES NO
b. If “YES”, please specify (e.g., existing data, census data, experimental data previously collected
for a different purpose).
c. If “YES”, will there be any personally identifiable information attached to the data whereby the
researcher may be able to identify individuals?
2. Intent to Publish or Present:Where will the results be published, presented, or displayed(e.g.,
textbooks, training videos, theses, dissertations, journals, internet)?
The data will be published in academic journals as a research paper
I. ASSURANCE STATEMENTS AND SIGNATURES
I understand the institution’s policy concerning research involving human participants and I agree:
 To obtain voluntary and written informed consent of subjects who are to participate in this project
(when required, as explained previously).
 To report to the IRB any unanticipated effects on subjects which become apparent during the
course of, or as a result of the research, and I will report what actions I have taken.
 To cooperate with members of the IRB charged with the continuing review of this project, and
therefore furnish relevant information when requested.
 To obtain prior approval from the IRB before amending or altering the scope of the project or
implementing changes in the approved consent form.
 To maintain documentation of consent forms and progress reports as required by the IRB.
 To protect confidentiality of research subjects and the data collected.
 To be responsible for the ethical conduct of this project, and for protecting the rights and welfare
of the subjects.
 To follow through with what is explained on the informed consent.
 To provide amended procedures to the IRB as these occur.
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Office of the UVU IRB
December 3, 2013
Principal Investigator:
Signature: __________________________________Date: ____CITI No. _____________
Co-Investigator(s) or Other Researcher(s): If you are a mentor of the PI, by signing you undertake
to be fully responsible for the ethical and legal conduct of the study/research.
Signature: __________________________________Date: ____CITI No. _____________
Signature: __________________________________Date: ____CITI No. _____________
Department Chair/Program Director:
Signature: __________________________________Date: ____CITI No. _____________
Dean (Dean must sign only if full IRB review is necessary)
Signature: __________________________________Date: ____CITI No. _____________
Paperwork submitted:
Application for Approval for the Use of Human Subjects in Research
Research Instrument
Participant Consent Form or Letter (blank copy)
Organizational Letter(s) of agreement to participate (if applicable)
Submit completed packet to the following:
On-Campus: Off-Campus:
Office of the IRB Utah Valley University
Mailstop: 272 Office of the IRB
Office: BA 203d 800 West University Parkway, MS272
Orem, UT 84058-5999
FOR OFFICE USE ONLY Date Received: _______________
IRB Action (to be completed by the IRB Administrator):
Exempt Determination:It has been determined that this research is exempt; data collection can begin.
Expedited Review Approval:This research has been approved, and data collection can begin.
Full IRB Review Approval:This research has been approved, and data collection can begin.
_____________________________________________________ Date: ___________________
(Signature of the IRB Administrator)
IRB Code: __________________
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