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Institutional Review Board ApplicationFORHUMAN SUBJECTS Research

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The University of Phoenix Institutional Review Board (IRB) exists to ensure university compliance with federal regulations regarding research involving human subjects.  This application is used to facilitate and document this compliance review.  Research projects which meet the federal definition for research and the federal definition of human subjects must be approved by the University of Phoenix IRB before any data collection begins.  If an IRB application is approved by the IRB and, later, the nature of the research design, requirements, or site locations change, a revised application describing these changes must be submitted for reconsideration and approval by the IRB.  This application is intended as a stand alone document, so reference to other documents or appendices of dissertation proposals or other research studies does not substitute for direct provision of that information as part of this application, either as a response within a section or as an addendum.  This application pertains to both pilot studies and full studies.  Please note that it is the researcher’s responsibility to give complete and accurate information about the nature of the proposed study, particularly in terms of the effects on, and expectations for, subject participants.  Please note that you must document currency in CITI certification as part of this application.

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Name of Researcher(s) City, State, and Country / School or College and University  

Affiliation

(student, faculty, or staff and id)

 

Type of Research

(research study, *funded research, or other)

[city/state]

[college]

University of Phoenix

 

 

IRN:LEAVE THIS BLANK

 

 

 

 

* If research is funded, please complete the followingagency information.  Otherwise, leave blank.

agency submitted to submission date location of project
 

 

 

/  /

 

1. Title of the Research Study/Dissertation:

 

2.    Classification of the Study:

 

a) Will primary data collection from human subjects be done in this study?

 

() Yes, original data only is collected from human subjects and no archival data will be used.

() Yes, both original data from human subjects and archival data will be collected and used.

()No, only archival data will be used.

 

b) Are the research study results generalizable or relevant to a larger population or only relevant to one

organization or entity?

 

()Results are generalizable to a larger population.

 

() Results are relevant only to one organization or entity.

 

a. Children/minors under age 18? Yes () No ()
b. Prisoners? Yes () No ()
c. Pregnant women? Yes () No ()
d. Cognitively impaired or mentally

disabled?

Yes () No ()
    e. Educationally or economically

disadvantaged?

Yes () No ()
Will the subjects be traumatized, comatose, or terminally ill patients? Yes () No ()
Will the subjects be elderly or aged persons? Yes () No ()
Will the subjects be minorities (including women)? Yes () No ()
Will information be withheld from subjects prior to, or during, participation? Yes () No ()
Will the subjects be college students? Yes () No ()
Will the subjects be deceived, misled, or coerced in any way? Yes () No ()
Will/might the subjects be students of the University of Phoenix? Yes () No ()
Will/might the subjects be faculty or staff of the University of Phoenix? Yes () No ()
Will information be requested that is, or may be, personal or sensitive? Yes () No ()
If the subjects are active duty military, will their supervisors have influence on their participation in this research or will participation be affected at all by the reporting relationship(s)? Yes () No ()
Will any aspect of this study involve subjects from countries outside of the U.S.?  If yes, please specify in the comments section below.  

Yes ()

 

No ()

 

Comments:

 

 

 

 

 

 

 

 

 

 

 

6.  Subject Recruitment and Selection:Briefly explain and address the following:

 

      a)  Which of the following will be used to find and recruit subjects? (check all that apply and include copies with

           this application)

 

()   Flyers                                                      ()  Email Announcement

()   Events, Meetings, Conferences           ()  Area Canvassing

()   Phone Solicitation ()  Registry

()   Newspaper/Radio/Television ()  Referrals from Others

()   Institutional “gatekeepers”                  ()  Direct Mail

()   Face to Face Interaction                       ()  Internet/Websites

()   Bulletin Board Post                               ()  Social Media (e.g. LinkedIn, Facebook, etc.) (please specify

()   Poster                                                                        below; documented use permission is required)

()  PhoenixConnect (please note if this is used,

separate prior approval through the UOPX

Committee on Research must be documented)

 

()   Other (please specify)____________________________________________      

 

       EXPLAIN AND DESCRIBE HERE IF SOCIAL MEDIA WILL BE USED ____________________________________

 

      b)  What is the anticipated sample size?

() 10 or less    () 11-20     () 21-50    () 51-99     () 100-199    () 200 or more

 

      c) Will any external parties (such as editors, translators, interpreters, statisticians, etc.) provide assistance for

recruitment purposes? (This does not pertain to persons who assist recruitment by “snowball sampling”.)

 

() No            () Yes (please identify and explain how they will assist) _____________________________

 

 

  d)  Are any of the research subjects students, employees, or patients of the researcher?

() Yes         () No

 

e)  If any potential subjects under the age of 18 years are not selected to participate in this study, what activities

          will they be doing during the time the subjects are participating in the study so that they do not feel excluded

          or left out? If this scenario does not pertain to the study, please indicate “Not applicable” here.

 

 

 

 f)  Please briefly describe the criteria that will be used to determine the inclusion or exclusion of subjects for

this study.

 

 

 

     g)  Will any compensation or remuneration be given to subjects for their participation in this study?

() No            () Yes (please identify amount and type, and the plan for dissemination.

 

 

        PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION OR EXPLANATION CONCERNING THE ABOVE QUESTIONS THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING THE RECRUITMENT OF SUBJECTS FOR YOUR RESEARCH STUDY.

 

 

 

 

7.  Informed Consent:Briefly explain and address the following questions.

 

 

a)  How will subjects be informed of the study’s purpose, procedures, intent, duration of the study and any

potential risks or discomforts to them? Check all that apply:

() Informed Consent form  () Email  () Letter  () Meeting () Phone Call () Other _______

 

b)  How will subjects be informed of withdrawal procedures? Check all that apply:

() Informed Consent form  () Email  () Letter  () Meeting () Phone Call () Other _______

 

     c)  How will the researcher contact information be provided to the subjects? Check all that apply:

() Informed Consent form  () Email  () Letter  () Meeting () Phone Call () Other _______

 

     d)  How will subjects withdraw from the study as participants after data collection is completed?

() Email the researcher    () Phone call to researcher    () Submit withdrawal form

() Other (please specify) ___________________________________________________________

 

     e)  Please explain what subjects must do to withdraw from the study after data is collected and how subject data

 will be retrieved and handled to ensure security and confidentiality.

 

 

 

 

    f)  If any subjects are under the age of 18 years, parental consent is required.  What provision is made to

answer any questions the parents have about this study or to address any individual concerns?  (For example,

 will there be an informational meeting with the parents, etc.?) If this scenario does not apply to this study,

        please indicate “Not applicable” here.

 

 

 

 

PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION

OR EXPLANATION THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING ANY OF THE ABOVE

QUESTIONS OR ABOUT THE INFORMED CONSENT FOR YOUR RESEARCH STUDY.

 

 

 

 

PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOXES BELOW:

I attest that no primary data collection from human subjects will occur  without a prior signed Informed

Consent form completed for each subject and that Informed Consent documentation will be retained

separately from study data.

 

I attest that a process for subject withdrawal will be implemented whereby subjects may withdraw without

penalty before, during and after data collection has been completed and submitted and that the

information they provided will be identified, secured, withdrawn and kept confidential.

 

 

8.  Confidentiality and Privacy:Briefly explain and address how the identity and privacy of the individualsubjects will be protected.  Check any of the following that apply:

 

       a) How will subject identity and data be protected?

()   Subject names will not be used or identified

()   Pseudonyms or numbers will be used instead of subject names

()   Data will be coded alphanumerically

()   Other (please specify) ________________________________________________

 

b) Will any audio and/or video tape or other recording of data be done in this study?

() Yes                               () No

 

       c) How long will the study data be kept after study completion?

()   Three years (please note this is the minimum required retention time)

()   More than three years

 

      d) Where will the data be stored:

()  In an office or other location at the researcher’s residence

()  At an office at the researcher’s place of employment

()  At a third party facility (please specify) ________________________________

()  Other (please specify) ______________________________________________

 

e) How will data be destroyed at the appropriate time?

()  Shredding            ()  Burning or incineration        ()  Smashing          () File Deletion

()  Other (please specify) ______________________________________________

 

  f)  How will the results of this study be disseminated?

() Publication            () Presentation             ()  Other _____________________________

 

       PLEASE PROVIDE HERE (OR AS AN ADDENDUM TO THIS APPLICATION) ANY ADDITIONAL INFORMATION OR EXPLANATION CONCERNING THE ABOVE THAT YOU THINK MAY BE HELPFUL TO THE IRB REGARDING CONFIDENTIALITY AND PRIVACY CONCERNS ASSOCIATED WITH YOUR RESEARCH STUDY.

 

 

 

PLEASE READ AND CONFIRM THROUGH CHECK MARKING THE BOX BELOW:

I attest that the data from this research will be kept in a secured location forat least three years following

study completion, and then will be permanently destroyed.

 

 

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