PSY 335 Week 4 Mock IRB Proposal Worksheet

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PSY 335 Week 4 Mock IRB Proposal WorksheetComplete the IRB Proposal Worksheet in relation to your group proposal.Click the Assignment Files tab to submit your assignment.Institutional Review Board Application                                        FOR HUMAN SUBJECTS Research 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.  
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 following agency information.  Otherwise, leave blank.agency submitted tosubmission datelocation 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.                  3.   Purpose and Anticipated Study Goal(s) and Benefits:   Briefly describe the following: The purpose of the study:  The anticipated study goal(s):  The benefits of the study to the subjects, to the organization, and to society:   3.1    Data Usage and Ownership:    If your research involves access to, and/or use of, a pre-existing private or restricted database (one that is not open access/publically available), please briefly describe the type of data in the database, the organization or individual owner or controller of the data, how the data will be accessed and how data confidentiality will be ensured.           a)  Does this research study involve access to, or use of public, open access databases or               datasets,  resources, recruitment lists, contact information for potential subjects or any other pre-               existing public data? (Note that “open access” means free and available to the general public without               restriction or prior permission needed.)                 () No                       () Yes (Please describe here)            b)  Does this research study involve access to, or use of private databases or datasets, private resources or               recruitment lists, contact information for potential subjects or any other pre-existing private data?                 () No                       () Yes (Please describe here and document permission granted for access and                                                                     use)            c)  During data collection or subject recruitment, will access be needed to any health information created,             received or archived by health care providers, clearinghouses, or health care plans that pertains to the             past, present or future health conditions or provision of health care to an individual living or deceased?                 () Yes                       () No                  () HIPAA compliance (if health records are used, please discuss here and address HIPAA compliance)                     d)  Will school or student related data be collected in this study?                () Yes, individual student data        () Yes, aggregate student data         () No                 () FERPA compliance (if student data is used, please explain here and address FERPA compliance)        4.   Project Description:   Briefly explain and address the following questions as indicated:        a) Who are the subjects of this study and where are they located? (for example, lawyers in private practice in the State of Ohio)          b)  What are the subjects expected to do as participants in this study and what is the time commitment involved? Please explain. If class time is used, please describe the activities planned for non-participants.         c) Will a pilot study be conducted before the primary data collection occurs?  () No    ()  Yes       d) What is the research method and design? Check all that apply:            () quantitative analysis         () qualitative analysis          () mixed methods            ()  phenomenological  () case study    ()  experimental   () quasi experimental    () Delphi            () other (specify)  ___________________________________________                 e)  How will data be collected? Check any that apply:            () face to face interview  () focus group  () online survey  () mail survey  () telephone survey             () onsite survey  () email survey  () Skype or related technology              () other (specify) ____________________________                          f) Where will data collection occur? Check any that apply and specify the location(s) below.            () organizational site  () online  () private premises   () public facility  () open access site           () other      () not applicable                               Location __________________________________________       g)  What is the degree or magnitude of risk/stress (physical, psychological, emotional, legal, financial) to the              human subjects because of their participation in this study?              () minimal risk/stress, not greater than encountered in ordinary daily life/activities or routine tests.            () greater than minimal risk/stress with potential for direct benefit to the individual subjects            () greater than minimal risk/stress with little/no potential direct benefit to individual subjects       h) If greater than minimal risk/stress to the human subject is possible, please explain how the risk/stress will be mitigated or lessened.         i) Are any third parties assisting with this study that will have access to the data?           () No   () Yes (specify) ______________________________________       j) Will any aspect of the study take place outside of the United States?            () No   () Yes (specify where) _______________________________________              Note that IRB approval may be needed in the country where research is taking place.             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 YOUR RESEARCH STUDY           DESIGN OR IMPLEMENTATION.      5.  Subject Groups:  Will the subjects recruited to participate in this study include any that are in protected groups identified below as specified within the federal human subject guidelines? (The guidelines are defined at www.citiprogram.org)             If any category from this list is checked “yes”, please explain in the “Comments” area below how the subjects will be protected from harm, risk, or stress as a study participant and how stress/risk will be mitigated or lessened.     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 individual subjects 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 for at least three years following              study completion, and then will be permanently destroyed. 
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