Application for IRB Review of Proposed Research* *Item-by-item instructions to fill out the application are available at https://www.saintleo.edu/application-directions-and-forms Applicants checking one or more items marked with an asterisk (*) in part 1, MUST complete parts 1 and 2. Applicants NOT checking any of those items, only fill out Part 1. PART 1 – TO BE FILLED BY ALL APPLICANTS 1. Principal Investigator’s full name (ONE full name only): 2. Organization: 3. Department: 4. Program name: 5. Program level: ___ Undergraduate ___ Graduate ___ N/A 6. Email address: 7. Local phone number: 8. Co-investigator(s): 9. Faculty advisor (if student research; ONE advisor’s name only): 10. Faculty advisor’s email address: 11. Project title: 12. Expected project start date: 13. Projected end date: 14. Number of research projects that the listed PI has completed as Principal Investigator before the one proposed here: 15. Number of other research projects in which the listed PI has collected information on human subjects prior to the one proposed here: 16. Please describe the purpose(s) or goal(s) of your study. Include your research question(s) or hypothesis(es) if applicable. 17. Research methods (Mark all that apply with an X) ___ Survey (attach questionnaire) ___ Interviews (attach questionnaire or interview guide) ___ Focus Group(s) ___ 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 ___ 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. Number of participants: 21. Types of participants (Mark all that apply with an X): ___ Adults (18 and older) ___ Elected officials ___ Saint Leo students+ ___ 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 recruitment materials to be added to the application. ++ 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: 23. Sampling strategy: ___ Convenience/availability ___ Random/probability ___ Snow-ball ___ Purposive/judgmental/theoretical ___ Other, specify: ______________________________ 24. Recruitment strategy (Mark all that apply with an X): ___ Individual contacts (in person, by phone, or by mail) ___ Email announcements ___ Public announcements (including through social media) ___ Flyers ___ Other, specify: ______________________________ 25. Indicate the agencies who give approval for the recruitment or data collection (indicate any funders or organizations from which you obtain participants or their data): 26. What type of consent process will you use? (Mark all that apply with an 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) ___ 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? 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* ___ No 30. For how long do you plan to keep your data? 31. How will you store your data? (Check all that apply): ___ Locked file cabinet ___ Password-protected computer ___ Locked office ___ Locked safe ___ Other, specify:________________________________________ 32. How will you report your research? (Mark all that apply with an X) ___ Publication (including in professional journal) ___ Public presentation (including at professional meeting or to an outside agency) ___ Report for an outside organization ___ Master’s thesis or dissertation ___ Senior thesis project ___ Class paper ___ In-class presentation ___ Other, specify:________________________________________ 33. Does the research involve any deception of the participants? ___ Yes* ___ No 34. Does the research involve any cost to participants? ___ Yes* ___ No 35. Risk involved in participating in this research (Mark all that apply with an X): < https://www.saintleo.edu/application-directions-and-forms View definition of minimal risk: https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 > ___ 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): ___ 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 ___ 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. ___ 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. ___ I have obtained the required ethics training certification, as described on the IRB webpage at https://www.saintleo.edu/irb-research-ethics-certification ___ If a student, I have received guidance from my faculty advisor and obtained his/her signature ___ If a first time undergraduate Prin
cipal Investigator, my research involves no risk greater than those encountered in daily life < https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 > I also certify that I have included all necessary supplemental documentation, as applicable to my research (check all that apply): ___ Data collection instrument(s), such as survey, interview questionnaire(s), or protocols for experiments ___ Consent form template(s) ___ Assent form template(s) ___ Implied consent statement template(s) ___ 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) ___ Letter of Authorization from outside agency to conduct the specific research 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 ___ Proof of completion of ethical training (see more information on the IRB webpage at https://www.saintleo.edu/irb-research-ethics-certification) with at least 6 months validity, to be renewed if the study extends beyond that date. ___ 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 https://www.saintleo.edu/irb-research-ethics-certification) I accept the following responsibilities (please check each after reviewing): ___ I will not start collecting any data for this project before obtaining IRB approval of the proposal. ___ I will obtain approval from the Saint Leo IRB prior to instituting any change in the project protocol. ___ I will bring to the attention of the Saint Leo IRB the development of any unexpected risks or ethical concerns. ___ 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. ___ 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: _______________________________________________ Date: _____________________  37. (Student research only) Faculty advisor statement of responsibility I, the faculty advisor for this research project, certify the following: ___ I have reviewed this entire application and assisted the PI in designing his/her research project. ___ 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: https://www.saintleo.edu/irb-who-should-submit-an-application https://www.saintleo.edu/application-directions-and-forms ___ I approve the research project as outline in this application. ___ I will assist the PI in making any revisions requested by the Saint Leo IRB. ___ I will assist the PI in the completion of the research and will continuously monitor all study related activities throughout the research period. ___ I will ensure that the PI submits a modified application for review, should any modifications to the research plan occur. ___ 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. ___ My ethics certification is valid for at least another 6 months and is attached to this application. https://www.saintleo.edu/irb-research-ethics-certification ___ I will renew my ethics certification at expiration, if it expires before the PI’s research project is completed. ___ 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: __________________________________________ Date ________________________   Applicants NOT checking any of those items marked with an asterisk (*), only fill out Part 1. https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 Applicants checking one or more items marked with an asterisk (*) in part 1, MUST complete parts 1 and 2. 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:  Valid certification (Expiration date: / / )  Certification expired  No certification Faculty Advisor:  N/A  Valid certification (Expiration date: / /)  Certification expired  No certification Type of review:  Exempt  Expedited  Full Decision:  Approved  Minor Revisions Required Minor revisions required: _____________________________________________________________________________ __________________________________________________________________________________________________  Revise and resubmit Revisions required: __________________________________________________________________________________ __________________________________________________________________________________________________  Not approved Justification for non approval: _________________________________________________________________________ __________________________________________________________________________________________________ IRB representative’s signature: ______________________________________________ Date: _____________________  .  
 
Application for IRB Review of Proposed Research*
 
*Item-by-item instructions to fill out the application are available at https://www.saintleo.edu/application-directions-and-forms
 
Applicants checking one or more items marked with an asterisk (*) in part 1, MUST complete parts 1 and 2.
Applicants NOT checking any of those items, only fill out Part 1.
 
PART 1 – TO BE FILLED BY ALL APPLICANTS
 

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

 

2. Organization:

 

3. Department:

 

4. Program name:

 

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

 

6. Email address:

 

7. Local phone number:

 

8. Co-investigator(s):

 

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

 

10. Faculty advisor’s email address:

 

11. Project title:

 

12. Expected project start date:

 

13. Projected end date:

 

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

 

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

 

16. Please describe the purpose(s) or goal(s) of your study. Include your research question(s) or hypothesis(es) if applicable.

 

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

 
___ Survey (attach questionnaire)
___ Interviews (attach questionnaire or interview guide)
___ Focus Group(s)
___ 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
___ 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. Number of participants:

 

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

 
___ Adults (18 and older)
___ Elected officials
 
___ Saint Leo students+
___ 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 recruitment materials to be added to the application.
++ 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:

 
 

23. Sampling strategy:

 
___ Convenience/availability
___ Random/probability
___ Snow-ball
___ Purposive/judgmental/theoretical
___ Other, specify: ______________________________
 

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

 
___ Individual contacts (in person, by phone, or by mail)
___ Email announcements
___ Public announcements (including through social media)
___ Flyers
___ Other, specify: ______________________________
 

25. 25. Indicate the agencies who give approval for the recruitment or data collection (indicate any funders or organizations from which you obtain participants or their data):

 

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

 

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*
___ No
 
 

30. For how long do you plan to keep your data?

 

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

 
___ Locked file cabinet
___ Password-protected computer
___ Locked office
___ Locked safe
___ Other, specify:________________________________________
 

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

 
___ Publication (including in professional journal)
___ Public presentation (including at professional meeting or to an outside agency)
___ Report for an outside organization
___ Master’s thesis or dissertation
___ Senior thesis project
___ Class paper
___ In-class presentation
___ Other, specify:________________________________________
 

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

 
___ Yes*
___ No
 

34. Does the research involve any cost to participants?

 
___ Yes*
___ No
 
 
 

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

< https://www.saintleo.edu/application-directions-and-forms
View definition of minimal risk: https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 >
 
___ 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):
 
___ 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
___ 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.
___ 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.
___ I have obtained the required ethics training certification, as described on the IRB webpage at https://www.saintleo.edu/irb-research-ethics-certification
___ 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 < https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 >
 
I also certify that I have included all necessary supplemental documentation, as applicable to my research (check all that apply):
 
___ Data collection instrument(s), such as survey, interview questionnaire(s), or protocols for experiments
___ Consent form template(s)
___ Assent form template(s)
___ Implied consent statement template(s)
___ 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)
___ Letter of Authorization from outside agency to conduct the specific research 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
___ Proof of completion of ethical training (see more information on the IRB webpage at
https://www.saintleo.edu/irb-research-ethics-certification) with at least 6 months validity, to be renewed if the study extends beyond that date.
___ 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 https://www.saintleo.edu/irb-research-ethics-certification)
 
I accept the following responsibilities (please check each after reviewing):
 
___ I will not start collecting any data for this project before obtaining IRB approval of the proposal.
___ I will obtain approval from the Saint Leo IRB prior to instituting any change in the project protocol.
___ I will bring to the attention of the Saint Leo IRB the development of any unexpected risks or ethical concerns.
___ 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.
___ 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:   _______________________________________________   Date: _____________________

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

 
I, the faculty advisor for this research project, certify the following:
 
___ I have reviewed this entire application and assisted the PI in designing his/her research project.
 
___ 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:
https://www.saintleo.edu/irb-who-should-submit-an-application
https://www.saintleo.edu/application-directions-and-forms
 
___ I approve the research project as outline in this application.
 
___ I will assist the PI in making any revisions requested by the Saint Leo IRB.
 
___ I will assist the PI in the completion of the research and will continuously monitor all study related activities throughout the research period.
 
___ I will ensure that the PI submits a modified application for review, should any modifications to the research plan occur.
 
___ 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.
 
___ My ethics certification is valid for at least another 6 months and is attached to this application.
https://www.saintleo.edu/irb-research-ethics-certification
___ I will renew my ethics certification at expiration, if it expires before the PI’s research project is completed.
 
 
___  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: __________________________________________       Date ________________________
 
 
 
Applicants NOT checking any of those items marked with an asterisk (*), only fill out Part 1.
https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211
 
Applicants checking one or more items marked with an asterisk (*) in part 1, MUST complete parts 1 and 2.
 
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 <do not delete>:
 
Verification of ethics training certification
 
PI:           q Valid certification (Expiration date: / / )            q Certification expired                 q No certification
 
Faculty Advisor:                                q N/A                  q Valid certification (Expiration date: / /)
q Certification expired                 q No certification
 
 
Type of review:                 q Exempt                           q Expedited                      q Full
 
 
Decision:                              q Approved
 
 
q Minor Revisions Required
Minor revisions required: _____________________________________________________________________________
__________________________________________________________________________________________________
 
 
q Revise and resubmit
Revisions required: __________________________________________________________________________________
__________________________________________________________________________________________________
 
 
q Not approved
Justification for non approval: _________________________________________________________________________
__________________________________________________________________________________________________
 
 
 
IRB representative’s signature: ______________________________________________      Date: _____________________
 
 
 
<<Start inserting required supplemental documents here, after deleting this statement>>

Application for IRB Review of Proposed Research* *Item-by-item instructions to fill out the application are available at https://www.saintleo.edu/application-directions-and-forms Applicants checking one or more items marked with an asterisk (*) in part 1, MUST complete parts 1 and 2. Applicants NOT checking any of those items, only fill out Part 1. PART 1 – TO BE FILLED BY ALL APPLICANTS 1. Principal Investigator’s full name (ONE full name only): 2. Organization: 3. Department: 4. Program name: 5. Program level: ___ Undergraduate ___ Graduate ___ N/A 6. Email address: 7. Local phone number: 8. Co-investigator(s): 9. Faculty advisor (if student research; ONE advisor’s name only): 10. Faculty advisor’s email address: 11. Project title: 12. Expected project start date: 13. Projected end date: 14. Number of research projects that the listed PI has completed as Principal Investigator before the one proposed here: 15. Number of other research projects in which the listed PI has collected information on human subjects prior to the one proposed here: 16. Please describe the purpose(s) or goal(s) of your study. Include your research question(s) or hypothesis(es) if applicable. 17. Research methods (Mark all that apply with an X) ___ Survey (attach questionnaire) ___ Interviews (attach questionnaire or interview guide) ___ Focus Group(s) ___ 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 ___ 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. Number of participants: 21. Types of participants (Mark all that apply with an X): ___ Adults (18 and older) ___ Elected officials ___ Saint Leo students+ ___ 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 recruitment materials to be added to the application. ++ 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: 23. Sampling strategy: ___ Convenience/availability ___ Random/probability ___ Snow-ball ___ Purposive/judgmental/theoretical ___ Other, specify: ______________________________ 24. Recruitment strategy (Mark all that apply with an X): ___ Individual contacts (in person, by phone, or by mail) ___ Email announcements ___ Public announcements (including through social media) ___ Flyers ___ Other, specify: ______________________________ 25. Indicate the agencies who give approval for the recruitment or data collection (indicate any funders or organizations from which you obtain participants or their data): 26. What type of consent process will you use? (Mark all that apply with an 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) ___ 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? 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* ___ No 30. For how long do you plan to keep your data? 31. How will you store your data? (Check all that apply): ___ Locked file cabinet ___ Password-protected computer ___ Locked office ___ Locked safe ___ Other, specify:________________________________________ 32. How will you report your research? (Mark all that apply with an X) ___ Publication (including in professional journal) ___ Public presentation (including at professional meeting or to an outside agency) ___ Report for an outside organization ___ Master’s thesis or dissertation ___ Senior thesis project ___ Class paper ___ In-class presentation ___ Other, specify:________________________________________ 33. Does the research involve any deception of the participants? ___ Yes* ___ No 34. Does the research involve any cost to participants? ___ Yes* ___ No 35. Risk involved in participating in this research (Mark all that apply with an X): < https://www.saintleo.edu/application-directions-and-forms View definition of minimal risk: https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 > ___ 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): ___ 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 ___ 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. ___ 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. ___ I have obtained the required ethics training certification, as described on the IRB webpage at https://www.saintleo.edu/irb-research-ethics-certification ___ If a student, I have received guidance from my faculty advisor and obtained his/her signature ___ If a first time undergraduate Prin
cipal Investigator, my research involves no risk greater than those encountered in daily life < https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 > I also certify that I have included all necessary supplemental documentation, as applicable to my research (check all that apply): ___ Data collection instrument(s), such as survey, interview questionnaire(s), or protocols for experiments ___ Consent form template(s) ___ Assent form template(s) ___ Implied consent statement template(s) ___ 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) ___ Letter of Authorization from outside agency to conduct the specific research 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 ___ Proof of completion of ethical training (see more information on the IRB webpage at https://www.saintleo.edu/irb-research-ethics-certification) with at least 6 months validity, to be renewed if the study extends beyond that date. ___ 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 https://www.saintleo.edu/irb-research-ethics-certification) I accept the following responsibilities (please check each after reviewing): ___ I will not start collecting any data for this project before obtaining IRB approval of the proposal. ___ I will obtain approval from the Saint Leo IRB prior to instituting any change in the project protocol. ___ I will bring to the attention of the Saint Leo IRB the development of any unexpected risks or ethical concerns. ___ 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. ___ 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: _______________________________________________ Date: _____________________  37. (Student research only) Faculty advisor statement of responsibility I, the faculty advisor for this research project, certify the following: ___ I have reviewed this entire application and assisted the PI in designing his/her research project. ___ 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: https://www.saintleo.edu/irb-who-should-submit-an-application https://www.saintleo.edu/application-directions-and-forms ___ I approve the research project as outline in this application. ___ I will assist the PI in making any revisions requested by the Saint Leo IRB. ___ I will assist the PI in the completion of the research and will continuously monitor all study related activities throughout the research period. ___ I will ensure that the PI submits a modified application for review, should any modifications to the research plan occur. ___ 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. ___ My ethics certification is valid for at least another 6 months and is attached to this application. https://www.saintleo.edu/irb-research-ethics-certification ___ I will renew my ethics certification at expiration, if it expires before the PI’s research project is completed. ___ 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: __________________________________________ Date ________________________   Applicants NOT checking any of those items marked with an asterisk (*), only fill out Part 1. https://cdn2.hubspot.net/hubfs/206683/Resource%20PDFs%20and%20DOCs/IRB%20Institutional%20Review%20Board/Defining%20Minimal%20Risk.pdf?t=1534255440211 Applicants checking one or more items marked with an asterisk (*) in part 1, MUST complete parts 1 and 2. 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:  Valid certification (Expiration date: / / )  Certification expired  No certification Faculty Advisor:  N/A  Valid certification (Expiration date: / /)  Certification expired  No certification Type of review:  Exempt  Expedited  Full Decision:  Approved  Minor Revisions Required Minor revisions required: _____________________________________________________________________________ __________________________________________________________________________________________________  Revise and resubmit Revisions required: __________________________________________________________________________________ __________________________________________________________________________________________________  Not approved Justification for non approval: _________________________________________________________________________ __________________________________________________________________________________________________ IRB representative’s signature: ______________________________________________ Date: _____________________