Final Proposal

Saint Leo University Institutional Review Board

Application for IRB Review of Proposed Research*

*Item-by-item instructions to fill out the application are available at http://www.saintleo.edu/resources/collaborative-research-institute/institutional-review-board-(irb)/irb-application-directions-and-forms.aspx

PART 1 – TO BE FILLED BY ALL APPLICANTS

Applicants checking one or more items marked with an asterisk (*) in part 1, please complete parts 1 and 2. Applicants NOT checking any of those items, please only fill out Part 1.

1. Principal Investigator’s full name ( ONE full name only ): James Spute III

2. Organization: Saint Leo University

3. Department: Social Sciences

4. Program name: Psychology

5. Program level: _X_ Undergraduate ___ Graduate ___ N/A

6. Email address: [email protected]

7. Local phone number: 321-626-4788

8. Co-investigator(s): Not Applicable

9. Faculty advisor (if student research; ONE advisor’s name only ): Tammy Zacchilli

10. Faculty advisor’s email address: [email protected]

11. Project title: How Preferred Music Genres and Personality Relate to Levels of Empathy

12. Expected project start date: Upon Approval

13. Projected end date: One year from approval

14. Number of research projects that the listed PI has completed as Principal Investigator before the one proposed here: one

15. Number of other research projects in which the listed PI has collected information on human subjects prior to the one proposed here: one

16. Please describe the purpose(s) or goal(s) of your study. Include your research question(s) or hypothesis(es) if applicable. This study is an extension of my previous study, examining the correlation between musical preference and empathy, as well as include the big five personality traits. Participants will complete a background inventory and three surveys through an online link through Qualtrics. We predict that participants who score high in the Reflective & complex music preference category will have higher levels of empathy than those in Intense & rebellious, upbeat & conventional, and Energetic & Rhythmic categories.

17. Research methods (Mark all that apply with an X)

_x_ Survey (attach questionnaire)

___ Interviews (attach questionnaire or interview guide)

___ Participant observation

___ Unobtrusive observation

___ Experiment (attach description detailed in a protocol and any instruments used)

___ 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, provide documentation from an authorized representative of this organization indicating that you have permission to conduct your research there. If this organization has its own IRB, provide proof of IRB approval.

2) Be aware that the use of copyrighted material has to be authorized by the copyright holder.

18. Type of instrument used:

___ Paper questionnaire, Survey, interview guide

_x_ Online questionnaire, Survey, interview guide

___ Pre-post survey

___ Experimental design (protocol must be attached)

___ None (note-taking)

___ Not applicable (use of existing data)

___ Other, specify: _______________________________________________________

19. How long do you anticipate that it will take the participants to complete the research procedure(s)? 20 minutes

20. Number of participants: 100

21. Types of participants (Mark all that apply with an X):

_x_ Adults (18 and older)

_x_ Saint Leo students

___ Elected officials

___ Saint Leo University personnel+

___ Minors (under 18, includes Saint Leo students under 18)*

___ Individuals diagnosed with a mental disorder or illness*

___ Terminally-ill patients*

___ Incarcerated individuals*

___ Undocumented immigrants*

___ Convicted felons*

___ Other sensitive populations, specify*: ____________________________________________

+ Requires additional permission from the VPAA after approval of the IRB. IRB approval does not guarantee approval by the appropriate Saint Leo administrators.

22. Please briefly describe your participants, including the social categories you are drawing from or targeting (race/ethnicity, gender, occupation, age group, military status, etc.), or any other relevant characteristics of your sample: Participants will be students of Saint Leo University that are 18 years of age or older and will include all races applicable to Saint Leo University and all class standings.

23. Sampling strategy:

_x_ Convenience/availability

___ Random/probability

___ Snow-ball

___ Purposive/judgmental/theoretical

___ Other, specify: ______________________________

24. Recruitment strategy (Mark all that apply with an X):

_x_ Individual contacts (in person, by phone, or by mail)

_x_ Email announcements

_x_ Public announcements (including through social media)

___ Flyers

___ Other, specify: ______________________________

25. Agencies involved with recruitment or data collection (indicate any funders or organizations from which you obtain participants or their data): Saint Leo University

26. What type of consent process will you use? (Mark all that apply with an X)

_x_ Implied consent (attach template implied consent statement)

___ Consent form (attach template consent form)

___ Assent (attach template consent form or statement)

___ Not applicable (research on publicly available data)

___ Other, specify: _________________________________

27. Data recording method (Mark all that apply with an X):

___ Written (includes notes, participants filling out a paper questionnaire or survey)

_x_ Electronic (online survey, email, blog, etc.)

___ Audio

___ Video*

___ Photo*

___ Other, specify: __________________________________

___ Use of existing data

28. How long do you anticipate it will take you to collect all your data for this project? 2-3 months.

29. Will the data be linked to the individual participants’ identifying information (such as name, email address, social security number, video, picture, etc.)? This may include identifying information on the data collection instrument, or keeping a list of names matched to codes used in the data.

___ Yes*

_x_ No

30. For how long do you plan to keep your data? Up to 2 years for possible presentation or publication.

31. How will you store your data? (Check all that apply):

___ Locked file cabinet

_x_ Password-protected computer

___ Locked office

___ Locked safe

___ Other, specify:________________________________________

32. How will you report your research? (Mark all that apply with an X)

_X_ Publication (including in professional journal)

_X_ Public presentation (including at professional meeting or to an outside agency)

___ Report for an outside organization

___ Senior thesis project

___ Master’s thesis or dissertation

___ Class paper

___ In-class presentation

___ Other, specify:________________________________________

33. Does the research involve any deception of the participants?

___ Yes*

_X_ No

34. Does the research involve any cost to participants?

___ Yes*

_X_ No

35. Risk involved in participating in this research (Mark all that apply with an X):

_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*: ______________________________________

36. PI statement of responsibility

I, the Principal Investigator, certify that I have followed the guidelines as outlined in this application and in the instructions available on the IRB webpage at http://www.saintleo.edu/resources/collaborative-research-institute/institutional-review-board-(irb)/irb-application-directions-and-forms.aspx , including (check all that apply):

_X_ I have provided an answer to every single question in Part 1 of the application, leaving none blank. I understand that incomplete applications will be returned without review.

__ I checked one or more item(s) followed with an asterisk and I have answered every single question in Part 2 of the application, leaving none blank

_X_ I am submitting this application, including all supplemental documents, as ONE Word document. I understand that any other type of submission will be returned without review.

_X_ I have answered all questions truthfully. I understand that failure to do so will result in immediate revocation of any IRB approval, with the potential for further disciplinary action through my home institution.

_X_ I have obtained the required ethics training certification, as described on the IRB webpage at http://www.saintleo.edu/resources/collaborative-research-institute/institutional-review-board-(irb)/research-ethics-certification.aspx

_X_ If a student, I have received guidance from my faculty advisor and obtained his/her signature

___ If a first time undergraduate Principal Investigator, my research involves no risk greater than those encountered in daily life

I also certify that I have included all necessary supplemental documentation, as applicable to my research (check all that apply):

_X_ Data collection instrument(s), such as survey, interview questionnaire(s), or protocols for experiments

__ Consent form template(s)

___ Assent form template(s)

_X_ Implied consent statement template(s)

_X_ If using Saint Leo students and/or a vulnerable population marked with an asterisk in item 21, recruitment materials (email announcements, flyers, etc. to match the recruitment methods listed in item 24)

___ Authorization from outside agency

___ Proof of approval from outside agency IRB

___ If not a member of the Saint Leo community, proof of approval from my organization’s IRB

_X_ Proof of completion of ethical training (see more information on the IRB webpage at http://www.saintleo.edu/resources/collaborative-research-institute/institutional-review-board-(irb)/research-ethics-certification.aspx) with at least 6 months validity, to be renewed if the study extends beyond that date.

_X_ If I am submitting this application as a student, proof of completion of ethical training for my faculty advisor (see more information on the IRB webpage at http://www.saintleo.edu/resources/collaborative-research-institute/institutional-review-board-(irb)/research-ethics-certification.aspx)

I accept the following responsibilities (please check each after reviewing):

_X_ I will not start collecting any data for this project before obtaining IRB approval of the proposal.

_X_ I will obtain approval from the Saint Leo IRB prior to instituting any change in the project protocol.

_X_ I will bring to the attention of the Saint Leo IRB the development of any unexpected risks or ethical concerns.

_X_ I understand that the approval period is for exactly one year, and that all study activities will either cease prior to expiration, or I will submit a request for an extension prior to the expiration date.

_X_ I have read, understand and acknowledge the IRB bylaws.

___ I will keep signed informed consent forms (if required by the project) from each participant for five years after the completion of the project and will ensure proper storage.

PI’s signature: _____________James Spute ____________________ Date: _____2/1/2017____

37. ( Student research only ) Faculty advisor statement of responsibility

I, the faculty advisor for this research project, certify the following:

_X__ I have reviewed this entire application and assisted the PI in designing his/her research project

_X__ I have ensured that the PI has followed all instructions to fill out this application according to the guidelines provided by the Saint Leo IRB at http://www.saintleo.edu/resources/collaborative-research-institute/institutional-review-board-(irb)/irb-application-directions-and-forms.aspx

_X__ I approve the research project as outline in this application

_X__ I will assist the PI in making any revisions requested by the Saint Leo IRB

_X__ I will assist the PI in the completion of the research and will continuously monitor all study related activities throughout the research period.

_X__ I will ensure that the PI submits a modified application for review, should any modifications to the research plan occur.

_X__ I will ensure that the PI submits a request for continuation in a timely fashion, should the research be extended beyond the one-year IRB approval.

__X_ My ethics certification is valid for at least another 6 months and is attached to this application.

___ I will renew my ethics certification at expiration, if it expires before the PI’s research project is completed.

__X_ I understand that I will be held legally responsible in case of any violation of the IRB regulations by the research team.

Faculty Advisor’s Signature: 2/1/17

PART 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 to the academic community?

3. What type(s) of participants will you be using? Include any demographic information, such as age, gender, ethnicity, and any other social categories or groups that your research involves.

4. How will you contact and recruit participants for your study?

5. How will you secure informed consent from your participants?

6. Describe fully how you will collect, store, manage, analyze, and report your data. Include information regarding paper or electronic copies. If your data is linked or identifiable in any way, you must also describe how you will securely store your data and procedures for de-identification and study close out. If your data is collected electronically then you must also describe the program and security features that you will use.

7. How will you ensure participant anonymity or the confidentiality of the data during data collection, storage, analysis, and reporting? Please note that anonymity means that no information that can identify participants is collected in the data, while confidentiality means that such information is collected, but access to it is restricted.

8. Who will have access to the data? For what purposes?

9. How long will you keep the data, and why?

10. Describe fully any and all risks beyond those of daily life to which participants may be exposed as a result of participation in your study (legal, social, emotional, etc.).

11. How will you minimize the existing risk(s)?

*************************************************************************************

FOR IRB USE ONLY:

Verification of ethics training certification

PI: X Valid certification (Expiration date: 9/7 /18 ) Certification expired No certification

Faculty Advisor: N/A X Valid certification (Expiration date:3 /1 /19)

Certification expired No certification

Type of review: X Exempt Expedited Full

Decision: X Approved

Minor Revisions Required

Minor revisions required: _____________________________________________________________________________

__________________________________________________________________________________________________

Revise and resubmit

Revisions required: __________________________________________________________________________________

__________________________________________________________________________________________________

Not approved

Justification for non approval: _________________________________________________________________________

__________________________________________________________________________________________________

IRB representative’s signature: _Dr. Lisa Rapp-McCall _____________________________________________ Date: __2/1/2017___________________

COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM)

COURSEWORK REQUIREMENTS REPORT*

* NOTE: Scores on this Requirements Report reflect quiz completions at the time all requirements for the course were met. See list below for details. See separate Transcript Report for more recent quiz scores, including those on optional (supplemental) course elements.

· Name: James Spute (ID: 4386729)

· Email: [email protected]

· Institution Affiliation: Saint Leo University (ID: 1841)

· Institution Unit: Psychology

· Curriculum Group: Social & Behavioral Research - Basic/Refresher

· Course Learner Group: Same as Curriculum Group

· Stage: Stage 2 - Refresher Course

· Description: Choose this group to satisfy CITI training requirements for Investigators and staff involved primarily in Social/Behavioral Research with human subjects.h

•

Report ID:

17139071

•

Completion Date:

09/08/2015

•

Expiration Date:

09/07/2018

•

Minimum Passing:

70

•

Reported Score*:

100

REQUIRED AND ELECTIVE MODULES ONLY

DATE COMPLETED

SCORE

Saint Leo University (ID: 14106)

14

09

/14/

No Quiz

SBE Refresher 1 – Defining Research with Human Subjects (ID: 15029)

09

/03/

15

/2 (100%)

2

SBE Refresher 1 – Privacy and Confidentiality (ID: 15035)

09

/03/

15

2

/2 (100%)

SBE Refresher 1 – Assessing Risk (ID: 15034)

09

/03/

15

2

/2 (100%)

SBE Refresher 1 – Research with Children (ID: 15036)

09

/03/

15

2

/2 (100%)

SBE Refresher 1 – International Research (ID: 15028)

09

/03/

15

2

/2 (100%)

SBE Refresher 1 – History and Ethical Principles (ID: 936)

09

/08/

15

2

/2 (100%)

SBE Refresher 1 – Federal Regulations for Protecting Research Subjects (ID: 937)

/08/

09

15

/2 (100%)

2

SBE Refresher 1 – Informed Consent (ID: 938)

15

/08/

09

/2 (100%)

2

SBE Refresher 1 – Research with Prisoners (ID: 939)

15

/08/

09

2

/2 (100%)

SBE Refresher 1 – Research in Educational Settings (ID: 940)

09

/08/

15

2

/2 (100%)

SBE Refresher 1 – Instructions (ID: 943)

09

15

/08/

No Quiz

For this Report to be valid, the learner identified above must have had a valid affiliation with the CITI Program subscribing institution

identified above or have been a paid Independent Learner.

CITI Program

Email:

[email protected]

Phone: 305-243-7970

Web:

https://www.citiprogram.or

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