INCOMPLETE APPLICATIONS WILL BE RETURNED WITHOUT REVIEW

QUESTION

Saint Leo University Institutional Review Board – Application for IRB Review of Proposed ResearchAll Word processor files should be combined into ONE file for submission, with supplementalfiles placed AFTER this applicationINCOMPLETE APPLICATIONS WILL BE RETURNED WITHOUT REVIEWPART 1 – TO BE FILLED BY ALL APPLICANTSApplicants checking one or more items marked with an asterisk (*) in part 1, please complete parts 1and 2. Applicants NOT checking any of those items, please only fill out Part 1.Item-by-item instructions to fill out the application are available athttp://www.saintleo.edu/Academics/Institutional-Review-Board/IRB-Application-Forms1. Principal Investigator’s full name (ONE name only):2. Department:4. Email address:3. Organization:5. Local phone number:6. Co-investigator(s):7. Faculty advisor (if student research; ONE name only):8. Faculty advisor’s email address:9. Project title:10. Expected project start date:11. Projected end date:(Data collection may not start before IRB approval of the proposal. IRB approval is valid for one year. Youmay indicate “Upon approval” as your start date)12. Agencies involved (indicate any funders or organization from which you obtain participants):The following section will ask you a series of questions that will be used by the Institutional Review Board(IRB) to make determinations about the quality and appropriateness of your research design andmethods. In making decisions, the IRB must assume that you’ve answered all questions truthfully.Failure to do so will result in immediate revocation of any approval with the potential for furtherdisciplinary action through the university. Please be diligent, specific, and accurate in answering allquestions. We assume that you understood everything you were asked when you submit yourapplication; if you don’t, please contact the IRB at irb@saintleo.edu for more information.13. Please describe the purpose(s) or goal(s) of your study:14. Please describe your research plan (how you will recruit participants, what method of data collectionyou will use, including the type of instrument if applicable, how long will the procedures take, how longthe data collection will last, etc.):15. Research methods (Mark all that apply with an X)___ Survey (attach questionnaire)___ Experiment (attach description of the protocol and any instruments used)___ Interviews (attach questionnaire)___ Participant observation___ Unobtrusive observation___ Analysis of data that have already been collected (i.e., “archival” data)+___ Other, specify:+: For any non-public data, please include permission from the data holder.PLEASE NOTE:1) For any research conducted within an organization, include documentation from an authorizedrepresentative of this organization indicating that you have permission to conduct your research there.2) Be aware that the use of copyrighted material has to be authorized by the copyright holder.16. Number of participants:17. Types of participants (Mark all that apply with an X):___ Adults (18 and older)___ Minors (under 18, includes Saint Leo students under 18)*___ Saint Leo University personnel+___ Individuals diagnosed with a mental disorder or illness*___ Terminally-ill patients*___ Incarcerated individuals*___ Undocumented immigrants*___ Convicted felons*___ Elected officials___ Other sensitive populations, specify*:___ The use of animals, cell cultures, microorganisms, or other non-human participants+ Requires additional permission from the VPAA after approval of the IRB. IRB approval does notguarantee approval by the appropriate Saint Leo administrators.18. Sampling strategy:___ Convenience/availability___ Random/probability___ Snow-ball___ Purposive/judgmental/theoretical___ Other, specify:19. Recruitment strategy (Mark all that apply with an X):___ Individual contacts (in person, by phone, or by mail)___ Email announcements___ Flyers___ Public announcements___ Other, specify:20. Will the data be linked to the individual participants’ identifying information (such as name, emailaddress, social security number, picture, etc.), directly or using codes?___ Yes*___ No21. How will informed consent be obtained? (Mark all that apply with an X)___ Implied consent (attach statement)___ Consent form (attach form)___ Assent (attach form or statement)___ Other, specify:22 Data recording method (Mark all that apply with an X):___ Written notes (includes participants filling out a paper questionnaire)___ Electronic (online survey, email, blog, etc.)___ Audio___ Video*___ Photo*___ Other, specify:23. Does the research involve any deception of the participants?___ Yes*___ No24. Does the research involve any cost to participants?___ Yes*___ No25. Risk involved in participating in this research (Mark all that apply with an X):___ None above those incurred in daily life___ Physical injury, illness, or exposure to toxic or noxious substances*___ Emotional or psychological harm*___ Social (such as: embarrassment, damage to one’s reputation)*___ Legal*___ Financial*___ Other, specify*:26. How will you report your research? (Mark all that apply with an X)___ Publication (including in professional journal)___ Public presentation (including at professional meeting)___ Report for an outside organization___ Thesis___ Class paper___ In-class presentation___ Other, specify:27. PI statement of responsibilityI, the Principal Investigator, certify that I have provided all the information required in this application(check all that apply):Data collection instrument(s), such as survey or interview questionnaire(s)Consent form(s)Assent form(s)Implied consent statement(s)Authorization from outside agencyIf not a member of the Saint Leo community, proof of approval from my organization’s IRBProof of completion of ethical training for the PI and, if applicable, the faculty advisor. If usingthe CITI training, student applicants register as “Student Researchers” to complete theintroductory quiz and the student modules. Others complete the entire basic training. Applicantswith an expired certification may complete the refresher course only.I understand that incomplete applications will be returned without review. I accept the followingresponsibilities:I will obtain approval from the Saint Leo IRB prior to instituting any change in the projectprotocol.I will bring to the attention of the Saint Leo IRB the development of any unexpected risks.I have read, understand and acknowledge the IRB bylaws.I will keep signed informed consent forms, if required, from each study subject for the durationof the project and will ensure proper storage. (Faculty researchers and advisors are responsiblefor keeping informed consent forms for three years after the project terminates. DepartmentChairs assume responsibility if the faculty member leaves the University.)Signed:_________________________________________________________________________Principal InvestigatorDate28. (Student research only) Faculty advisor statement of responsibilityI, the faculty advisor for this research project, certify that my ethics certification is current, that I havereviewed this proposal, and that I approved its submission to the Saint Leo IRB. I understand that it ismy responsibility as faculty advisor to assist the PI with any necessary revisions to this proposal. Ifurther understand that I will be held legally responsible in case of any violation of the IRB regulationsby the research team.Signed:_________________________________________________________________________Faculty AdvisorDatePART 2 – TO BE FILLED BY APPLICANTS WHO CHECKED ONE OR MORE BOX(ES)FOR ITEMS FOLLOWED BY AN ASTERISK (*)Please provide detailed answers to the questions below.1. Describe the objective(s) of your study. What do you hope to accomplish?2. What are the expected benefit(s) of your research to the participants themselves, to society, and/or tothe academic community?3. What type(s) of participants will you be using? Include any demographic information, such as age,gender, ethnicity, to the best of your ability.4. How will you contact and recruit participants for your study?5. How will you secure informed consent from your participants?6. Describe how you will collect your data:7. Describe fully any and all risks beyond those of daily life to which participants may be exposed as aresult of participation in your study.8. How will you minimize the existing risk(s)?9. How will you ensure participant anonymity or confidentiality in the data collection, storage, andanalysis? (Anonymity is when participants are not identifiable from the data collected. Confidentiality iswhen they may be identifiable but for the protections you have put in place.)10. Who will have access to the data? For what purposes?11. How long will you keep the data?*************************************************************************************FOR IRB USE ONLY:Verification of ethics training certificationPIValid certificationCertification expired No certificationFaculty Advisor N/A Valid certificationType of review:ExemptDecision:Certification expired No certificationExpeditedFullApprovedMinor Revisions RequiredMinor revisions required: _____________________________________________________________________________________________________________________________________________________Revise and resubmitRevisions required: _____________________________________________________________________________________________________________________________________________________Not approvedJustification for non approval: ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________IRB representative’s signatureDate

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