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Application to the FGCU Institutional Review Board


Section I: Project/Study/Activity Information

Prior to submitting your completed application you will need the Department Chair and Dean approvals before your protocol will be approved. Please use the Save and Resume Later link at the bottom of the form. Send that link to the Department Chair and Dean for approval and any comments, changes or corrections they may request.

Once you submit this form, you may NOT go back in to make changes. You can send a copy to your Department Chair and College Dean for approval or possible changes using the Save and Resume Later link at the bottom of the form prior to submitting to Research Events.

When using the Save and Resume Later link, you will have 30 days to return and finish filling out the form, after which time your data will be lost. Each time you use the Save and Resume Later link, you will get a new link. Be sure to save and use the new link each time.

Note: Attachments (files only - no links) will only be saved upon final submission of the form.

I.A. Principal Investigator

PI Name*

I.B. Student Researcher, Co-investigator and Research Assistants

Who is involved in the study?*

I.C. Other Authorizers

Department Chair/Equivalent Name*
College Dean/Equivalent Name*
A physician signature is needed ONLY if the project involves medical procedures and the investigator is not a licensed physician. Will a physician be signing this application?*
Advising Physician Name*

I.D. Project Title

I intend to disseminate the results of the study through a thesis/dissertation, article, book, blog, website, conference, etc.*

Project Period From

Project Period To*

I.E. Location(s) of Project

List each location separately. Number each location and press Enter between each one.
Example:
1. Howard Hall 202
2. Marieb Hall 123

I.F. Regulatory Compliance Information

1. Type of Project/Study/Activity*
2. Project/Study/Activity Includes*
3. This project contains environmental sustainability component(s).*

I.G. Cooperating Institution or Entity

Will participants be recruited and/or data or information be obtained from an outside institution?*
If yes, please attach copy of the entity's email/letter letter of cooperation.
Attach copy of the entity's email/letter of cooperation.*
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I.H. Collaborating Institution or Entity

Is this research being undertaken with another entity outside of FGCU?*
If yes, please attach copy of the institution's letter letter and IRB approval letter and protocol, if appropriate.
Attach a copy of the collaborating institution's letter of cooperation and IRB approval letter and protocol, if appropriate.*
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*** When you forward this IRB Application to your faculty sponsor, be sure to attach all supporting documents. ***

Is the protocol approved by the collaborating institution's IRB?*

I.I. Sponsored Funding

Grant Status
Attach a copy of the grant to the application if a copy of the grant is not on file in ORSP.
Attach copy of the grant if a copy of the grant if not on file in ORSP.
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Is notification of IRB approval required?*
The PI, a co-investigator, research team member, or family member acts as an officer, director, or agent of the sponsor.*
The PI, a co-investigator, research team member, or family member receives compensation from the sponsor or its agent.*

I.J. Level of IRB Review Requested

Indicate below the level of IRB review you are requesting for your study. The Institutional Review Board reserves the right to determine the final level of review for the study.*

I.K. Conflict of Interest 


The ethical conduct of research with human subjects requires the disclosure of potential conflicts of interest. Please answer the following questions.

Important Note: Final IRB approval does not guarantee all potential conflict matters are addressed.

1. The PI, a co-investigator or research team member will recruit subjects who are also his/her students, employees, colleagues, subordinates, and/or acquaintances, family members, etc*
2. The PI, a co-investigator, research team member, or family member developed the technology, process or product involved in the study.*
3. The PI, a co-investigator, research team member, or family member, holds a financial interest in the technology, process or product involved in this study.*
4. The PI, a co-investigator, research team member, or family member is an employee of or holds an executive position in a business engaged in activities related to the study.*

Section II: Project/Study/Activity Description

II.A. Description

Attach a list of your citations and references.
List of citations and references*
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Pair and number question with associated hypothesis. Put each numbered pair on a separate line.
Example:
1. Question - Hypothesis
2. Question - Hypothesis

II.B. Data Collection 

Please provide the following information.

1. Identify the type of data you will collect.*
2. Are you collecting sensitive information such as sexual behavior, HIV status, psychological state, recreational drug use, illegal behaviors, child/ physical abuse, immigration status, etc?*
3. Will you have access to or are you collecting any personal identifiers such as names, telephone numbers, e-mail addresses, when scheduling appointments and/or social security numbers, medical record numbers, audio/video-recordings, biometric identifiers such as finger and voice prints, full face photographic images, any comparable images or data?*
4. Please identify all of the data collection methods you will use.*
5. Will the data be collected, transmitted, and/or stored via the internet?*
Please indicate which of the following measure(s) will be taken to ensure the security of data transmitted over the internet.*

II.C. Participant Population

Will primary participant(s) fall in one of the following vulnerable populations?
(Children under 18; Elderly; Pregnant women; Persons with mental or physical illness, impairment or disability; Prisoners; Under-represented populations; Persons who are Non-English speaking or English as a second language; Persons in a sensitive support program)*
1. Check all of the following vulnerable populations that apply to the primary participant(s) in your study.*
Please attach translated documents into the language of this group, ie., Informed Consent form, recruitment flyer, survey/interview questions, etc.*
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II.D. Participant Recruitment (invitation to participate in study/providing information about study)

1. Will participants be recruited/invited to participate, and/or have their data included in your study?*
a. Please identify ALL applicable recruitment methods you will employ in your study.*
Attach a copy of all advertising materials including ads, letters, telephone scripts, audio or videotapes, etc., including graphics to this application.*
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2. Will the participants be paid or receive other compensation such as a gift card or course extra credit?*
If extra credit, is offered, submit the alternate assignment for those who choose to not participate in the study.

II.E. Informed Consent

Does the study require a signed informed consent form or an assent form?*
Select option 2a or 2b below.*
I will be requesting an alteration to the information included in the signed consent form.*

Please describe the consent process by answering the following. Use the signed informed consent model to draft your consent form(s). If the study includes participants whose principal language is not English, a translation of all information provided to participants must be included.

Attach a copy of all consent documents printed on college or department letterhead.

Attach a copy of all consent documents printed on college or department letterhead.*
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You selected option 2a above. Be sure to select items i AND ii AND iii OR only item iv below.

i. The research involves no more than minimal risk to the subjects (document the risks in Section II.I. of the application) and does not involve procedures that normally require written consent outside of the research context.

ii. The waiver or alteration of the consent process will not adversely affect the rights and welfare of the participants.

iii. The research could not practicably be carried out without the waiver or alteration of the signed consent form. Examples: online survey, telephone interview, exit interview. Attach a copy of the appropriate consent form (oral,online, or modified written consent form)

iv. The above apply and the research involves deception which is explained in section II.G. Participants will be provided with pertinent information about the study prior to their participation. Attach a copy of the modified consent form and a copy of the explanation participants will receive following the study.

You selected option a above. Do you want items i AND ii AND iii OR only item iv?*
You selected option 2b above. Be sure to select item i or item ii below.*

The only record linking the subject and the research would be a signed consent document. The principal risk to participants would be potential harm resulting from a breach of confidentiality. Example: survey of illegal activities. Participants will be provided the option of receiving pertinent information about the study prior to their participation. The information participants will receive is based on the appropriate informed consent model and is attached to this application.

c. Consent Waiver Process

Please describe the consent process by answering the following. Use the appropriate consent model to draft your consent form(s). If the study includes participants whose principal language is not English, a translation of all information provided to participants must be included. ATTACH a copy of all consent documents printed on college or department letterhead.

II.F. Use of Device, Dietary Supplement, Product

1. The study involves the use of a device, instrument, apparatus, implement, machine, etc. Examples include powered and non-powered exercise equipment, therapeutic vibrating platform, daily activity assist device, etc.*
2. The study involves the use of a drug or dietary supplement (marketed herbs, vitamins, minerals sold over-the-counter).*
G. This study involves a placebo*
3. The study involves the use of a product such as elastic bandages or tape.*

II.G. Protocol

ATTACH a copy of each study instrument, including all questionnaires, surveys, data collection sheets, alternate class assignments, protocols for interviews, etc. to your application. - 1
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ATTACH a copy of each study instrument, including all questionnaires, surveys, data collection sheets, alternate class assignments, protocols for interviews, etc. to your application. - 2
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ATTACH a copy of each study instrument, including all questionnaires, surveys, data collection sheets, alternate class assignments, protocols for interviews, etc. to your application. - 3
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ATTACH a copy of each study instrument, including all questionnaires, surveys, data collection sheets, alternate class assignments, protocols for interviews, etc. to your application. - 4
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ATTACH a copy of each study instrument, including all questionnaires, surveys, data collection sheets, alternate class assignments, protocols for interviews, etc. to your application. - 5
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II.H. Confidentiality and Data Security (refers to how the data will be collected, not how it will be published)

[Please note the difference between anonymous data and confidential data, specimens and audio/video recordings… Anonymous data, specimens, audio/video recordings cannot be traced back to an individual participant and has never had any identifying information associated with it. A participants' identity/data will be confidential if an assigned ID code or number is used, but it will not be anonymous.]

1. Data Security (data, specimens, photographs, audio/video recordings, etc.)*
Select the confidentiality level of the data*
Select the format of the Confidential - Coded Data*
Select the format of the Confidential - Direct Identifiers*
4. Following the closure of the IRB file, study records, data, signed informed consent/assent forms, etc., will be held for a minimum of*

II.I. Risks

There are risks associated with the study.*
Example: the Investigator believes an activity is too physically or emotionally stressful for the participant and terminates the participant from the study.

II.J. Benefits

II.K. Research Team

Please provide the following information about your team members, including yourself, your faculty advisor, any research assistants and/or co-investigators and/or your dissertation or independent research committee members.

All members of the study involved in the consent process, recruiting, obtaining data, manipulating data*, or supervision of these activities, must complete human subjects protections training. FGCU accepts a completion certificate in human subjects research from the Collaborative Institutional Training Initiative (CITI). (https://www.citiprogram.org)

* Persons whose sole involvement with the study is the manipulation of data that is not anonymous must complete the human subjects in research training course. Persons whose sole involvement with the study is the manipulation of data that is anonymous do not need to complete the human subjects in research training course.

Note: Human subjects protection training must be renewed every five years.

Research Team Includes only the PI*
PI Name*
PI Role in Project*
PI CITI Course(s)*
Attach the CITI course completion certificate
PI CITI Social & Behavioral Course Completion Certificate
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PI CITI Biomed, Social & Behavioral Course Completion Certificate
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PI CITI HIPS Course Completion Certificate
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PI CITI Other Course Completion Certificate
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Student Researcher Name*
Student Researcher Role in Project
Student Researcher CITI Course(s)*
Student Researcher's CITI Social & Behavioral Course Completion Certificate
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Student Researcher's CITI Biomed, Social & Behavioral Course Completion Certificate
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Student Researcher's CITI HIPS Course Completion Certificate
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Student Researcher's CITI Other Course Completion Certificate
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Research Team Includes Co-PIs*
Co-PI #1 Name*
Co-PI #1 Role in Project
Co-PI #1 CITI Course(s)*
Co-PI #1 CITI Social & Behavioral Course Completion Certificate
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Co-PI #1 CITI Biomed, Social & Behavioral Course Completion Certificate
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Co-PI #1 CITI HIPS Course Completion Certificate
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Co-PI #1 CITI Other Course Completion Certificate
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Co-PI #2 Name*
Co-PI #2 Role in Project*
Co-PI #2 CITI Course(s)*
Co-PI #2 CITI Social & Behavioral Course Completion Certificate
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Co-PI #2 CITI Biomed, Social & Behavioral Course Completion Certificate
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Co-PI #2 CITI HIPS Course Completion Certificate
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Co-PI #2 CITI Other Course Completion Certificate
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Co-PI #3 Name*
Co-PI #3 Role in Project*
Co-PI #3 CITI Course(s)*
Co-PI #3 CITI Social & Behavioral Course Completion Certificate
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Co-PI #3 CITI Biomed, Social & Behavioral Course Completion Certificate
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Co-PI #3 CITI HIPS Course Completion Certificate
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Co-PI #3 CITI Other Course Completion Certificate
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Research team includes Research Assistants (including student research assistants)*
Research Assistant #1 Name*
Research Assistant #1 Role in Project*
Research Assistant #1 CITI Course(s)*
Research Assistant #1 CITI Social & Behavioral Course Completion Certificate
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Research Assistant #1 CITI Biomed, Social & Behavioral Course Completion Certificate
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Research Assistant #1 CITI HIPS Course Completion Certificate
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Research Assistant #1 CITI Other Course Completion Certificate
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Research Assistant #2 Name*
Research Assistant #2 Role in Project*
Research Assistant #2 CITI Course(s)*
Research Assistant #2 CITI Social & Behavioral Course Completion Certificate
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Research Assistant #2 CITI Biomed, Social & Behavioral Course Completion Certificate
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Research Assistant #2 CITI HIPS Course Completion Certificate
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Research Assistant #2 CITI Other Course Completion Certificate
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Research Assistant #3 Name*
Research Assistant #3 Role in Project*
Research Assistant #3 CITI Course(s)*
Research Assistant #3 CITI Social & Behavioral Course Completion Certificate
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Research Assistant #3 CITI Biomed, Social & Behavioral Course Completion Certificate
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Research Assistant #3 CITI HIPS Course Completion Certificate
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Research Assistant #3 CITI Other Course Completion Certificate
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Upload a file of all participant information. Be sure to include their full name, email, Academic Unit/Organization, position, the person's role in the project, and what CITI courses have been completed. Use the information required for the PI as a model for the information needed for all participants.*
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Section III: Additional Attachments

Will there be any additional attachments?*
Indicate which attachments are uploaded with this application*
HIPAA information and authorization / permission forms*
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Proposal for external support*
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Other supporting materials - 1*
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Other supporting materials - 2
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Other supporting materials - 3
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Other supporting materials - 4
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Section IV: Certification of Primary Investigator Responsibilities

I, the Primary Investigator agree/certify that:

1. The information provided in this IRB application is complete and correct.*
2. I understand I have the responsibility for the conduct of the study, the ethical performance of the study and the protection of the rights and welfare of study participants.*
3. I will maintain adequate, current, and accurate records of research data.*
4. The informed consent process will provide each participant with a copy of the consent, ensure they fully understand the purpose of the study, the nature of the procedures they are being asked to undergo, the potential risks of these procedures, and their rights as a study participant.*
5. No modification to the approved protocol or consent materials will be made without first obtaining approval by the Florida Gulf Coast University IRB.*
6. I will report to the Florida Gulf Coast University IRB in writing, unanticipated problems or adverse events that injure or cause harm to a participant within 24 hours of its occurrence.*
7. I will notify the Florida Gulf Coast University IRB promptly of any change in the research procedures necessitated in the interest of the safety of a given research participant.*
8. I will adhere to all requirements for continuing review of the study.*
9. I will notify the Florida Gulf Coast University IRB within 30 days of the closure of this study or graduation and submit the necessary paperwork for the IRB to close its file.*

My signature below indicates that I agree with all the Primary Investigator Responsibilities above.

Use your mouse or finger to draw your signature above
Date*

Form Submission

Prior to submitting your completed application you will need the Department Chair and Dean approvals before your protocol will be approved. Please use the Save and Resume Later link at the bottom of the form. Send that link to the Department Chair and Dean for approval and any comments, changes or corrections they may request.

Once you submit this form, you may NOT go back in to make changes. You can send a copy to your Department Chair and College Dean for approval or possible changes using the Save and Resume Later link below prior to submitting to Research Events.

When using the Save and Resume Later link, you will have 30 days to return and finish filling out the form, after which time your data will be lost. Each time you use the Save and Resume Later link, you will get a new link. Be sure to save and use the new link each time.

Note: Attachments (files only - no links) will only be saved upon final submission of the form.

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