IRB Amendment/Continuation/Closure Form

Request for Amendment / Continuation / Closure of IRB Protocol

The form has a signature field. Only the PI (non-student) must sign this form. Co-investigators do not need to sign the form.

If the PI is a student, complete this form but DO NOT SUBMIT IT. Instead of submitting the form, click the Save and Resume Later link at the bottom and enter your Faculty Sponsor's email when prompted. The Faculty Sponsor will review the form and submit it for the student PI.

Section I: Investigator Information

PI Name:*

Prefix (optional)

First Name

Last Name

PI is a Student:*

Yes No

Faculty Sponsor Name:*

Prefix (optional)

First Name

Last Name

College:*

Department/Division:*

PI Phone:*

PI Email:*

Section II: Protocol Information

IRB Number:*

Protocol Title:*

Protocol Category:*

Action To Be Taken For This Protocol

What action is needed for the above protocol?*

Amendment Continuation Closure

Requested Protocol Amendments

Change in Funding?*

Yes No/NA

A. Personnel Change

Please complete for all changes (PI, Co-Investigators, Staff, Post-docs, Students, Technicians, etc.)

Add Personnel*

None Add 1 Person Add 2 People Add More Than 2 People

Add Personnel 1: Name*

Prefix (optional)

First Name

Last Name

Add Personnel 1: Email*

Add Personnel 1: College*

Add Personnel 1: Faculty/Staff/Student*

Add Personnel 1: Role*

Add Personnel 1: Faculty/Staff/Student - Other*

Add Personnel 1: Role - Other*

Add Personnel 2: Name*

Prefix (optional)

First Name

Last Name

Email 2*

Add Personnel 2: College*

Add Personnel 2: Faculty/Staff/Student*

Add Personnel 2: Role*

Add Personnel 2: Faculty/Staff/Student - Other*

Add Personnel 2: Role - Other*

Add Personnel File Upload. Be sure to include Full Name, Email, College, Faculty/Staff/Student/Other - explained, Role (PI, Co-PI, Research Team Member, Other - explained)*

No File Chosen

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Remove Personnel*

None Remove 1 Person Remove 2 People Remove More Than 2 People

Remove Personnel 1: Name*

Prefix (optional)

First Name

Last Name

Remove Personnel 1: Email*

Remove Personnel 1: College*

Remove Personnel 1: Faculty/Staff/Student*

Remove Personnel 1: Role*

Remove Personnel 1: Faculty/Staff/Student - Other*

Remove Personnel 1: Role - Other*

Remove Personnel 2: Name*

Prefix (optional)

First Name

Last Name

Remove Personnel 2: Email*

Remove Personnel 2: College*

Remove Personnel 2: Faculty/Staff/Student*

Remove Personnel 2: Role*

Remove Personnel 2: Faculty/Staff/Student - Other*

Remove Personnel 2: Role - Other*

Remove Personnel File Upload. Be sure to include Full Name, Email, College, Faculty/Staff/Student/Other - explained, Role (PI, Co-PI, Research Team Member, Other - explained)*

No File Chosen

File uploads may not work on some mobile devices.

File formats accepted: pdf,doc,docx,csv,xls,xlsx,txt

B. Protocol Title Change

New Title*

C. Change in Study Population Age Range and Demographics

Indicate changes in population*

Indicate changes in population
	Adding	Removing	No Change
Minors under 18 (attach assent form)	Indicate changes in population: Minors under 18 (attach assent form) (Adding)	Minors under 18 (attach assent form) (Removing)	Minors under 18 (attach assent form) (No Change)
Prisoners	Prisoners (Adding)	Prisoners (Removing)	Prisoners (No Change)
Elderly	Elderly (Adding)	Elderly (Removing)	Elderly (No Change)
FGCU Students	FGCU Students (Adding)	FGCU Students (Removing)	FGCU Students (No Change)
Pregnant Women	Pregnant Women (Adding)	Pregnant Women (Removing)	Pregnant Women (No Change)
Fetus/fetal Tissue	Fetus/fetal Tissue (Adding)	Fetus/fetal Tissue (Removing)	Fetus/fetal Tissue (No Change)
Illiterate	Illiterate (Adding)	Illiterate (Removing)	Illiterate (No Change)
Economically disadvantaged	Economically disadvantaged (Adding)	Economically disadvantaged (Removing)	Economically disadvantaged (No Change)
Impaired cognitive functioning	Impaired cognitive functioning (Adding)	Impaired cognitive functioning (Removing)	Impaired cognitive functioning (No Change)
Not fluent in English	Not fluent in English (Adding)	Not fluent in English (Removing)	Not fluent in English (No Change)
Other (explain below)	Other (explain below) (Adding)	Other (explain below) (Removing)	Other (explain below) (No Change)

Other

Rationale for the change in demographics.*

Minors Assent Form

No File Chosen

File uploads may not work on some mobile devices.

File formats accepted: pdf, doc, docx, csv, xls, xlsx, txt

D. Change in the Number of Study Participants

Number to be added:*

Number to be deleted:*

Total number of subjects:*

Justification for the change in the number of subjects:*

E. Change in Recruitment Method(s)

Methods (Adding/Removing)*

Methods (Adding/Removing)
	Adding	Removing
Unsolicited group emailing	Methods (Adding/Removing): Unsolicited group emailing (Adding)	Unsolicited group emailing (Removing)
Facebook/posting on internet website	Facebook/posting on internet website (Adding)	Facebook/posting on internet website (Removing)
Twitter	Twitter (Adding)	Twitter (Removing)
Newspaper Ad	Newspaper Ad (Adding)	Newspaper Ad (Removing)
Brochure/flyer	Brochure/flyer (Adding)	Brochure/flyer (Removing)
TV ad/Public service anouncement	TV ad/Public service anouncement (Adding)	TV ad/Public service anouncement (Removing)
Telephone	Telephone (Adding)	Telephone (Removing)
Other (explain below)	Other (explain below) (Adding)	Other (explain below) (Removing)

Check all that apply

Other Method

Please indicate where/how the new recruitment method(s) will be placed/used.

Please provide the rationale for any new recruitment method(s). Attach the new recruitment material(s)

New recruiting materials.

No File Chosen

File uploads may not work on some mobile devices.

File formats accepted: pdf,doc,docx,csv,xls,xlsx,txt

F. Change in consent Process or Form

Please explain the change. Attach the new consent form if it is impacted by the change.*

New consent form if it is impacted by the change.

No File Chosen

File uploads may not work on some mobile devices.

File formats accepted: pdf,doc,docx,csv,xls,xlsx,txt

G. Change in Survey or Questionnaire

Please provide the rationale for the change. Attach any new instrument(s)..*

New instrument for change in questionnaire.*

No File Chosen

File uploads may not work on some mobile devices.

File formats accepted: pdf,doc,docx,csv,xls,xlsx,txt

H. Change in Protocol Procedures

Please explain.*

I. Change in Compensation

a. Amount of compensation (dollars, class credit, etc.)*

b. Type of compensation (cash, gift card, class credit, etc.)*

c. Source of funds to provide compensation.*

d. Indicate all payment/compensation/reimbursement arrangements including amounts/types and persons responsible for disbursement.*

e. Explain how, with the offer of compensation, you will protect against undue influence/coercion on a subject to participate in the study.*

f. If course extra credit is offered for participating in the study, what comparable non-research alternative will be offered for students who do not participate in the study?

Impact of Changes on Protocol

A. Please provide the IRB with any additional information you believe it would find useful. (up to 1,000 characters)

B. Does the proposed amendment change the level of physical, psychological and sociological risk to subjects?*

No Change Increases Decreases

Explanation for change in risk level.*

Requested Protocol Continuation

The protocol is continued*

with no modification with the following modifications requested

Total participating in the research to date:*

Have there been any adverse effects?*

Yes No

Please explain adverse effects:*

Have there been any complaints about the research?*

Yes No

Please explain complaints:*

Have there been any unanticipated problems involving risks to subjects or others?*

Yes No

Please explain unanticipated problems:*

Have there been any withdrawal of subjects from the research due to concerns about the research?*

Yes No

Please explain withdrawal of subjects:*

Do any preliminary findings have a potential effect on the welfare of your study participants?*

Yes No

Please explain potential effect on the welfare of study participants:*

The researcher continues to enroll new subjects.*

Yes No

Please explain continued enrollment of new subjects:*

The researcher closed enrollment in the study.*

Yes No

Please explain closing of enrollment:*

Additional information for the Board's consideration. (optional)

Requested Protocol Closure

Total participating in the research to date:*

Have there been any adverse effects?*

Yes No

Please explain adverse effects:*

Have there been any complaints about the research?*

Yes No

Please explain complaints:*

Have there been any unanticipated problems involving risks to subjects or others?*

Yes No

Please explain unanticipated problems:*

Have there been any withdrawal of subjects from the research due to concerns about the research?*

Yes No

Please explain withdrawal of subjects:*

Do any preliminary findings have a potential effect on the welfare of your study participants?*

Yes No

Please explain potential effect on the welfare of study participants:*

The researcher continues to collect, use, study and analyze identifiable private information.*

Yes No

Please explain collecting/using/studying/analyzing of identifiable private information:*

The researcher is analyzing data without individual subject identifiers.*

Yes No

Please explain analyzing of non-identifiable data:*

Additional information for the Board's consideration. (optional)

PI Signature

PI Signature*

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Use your mouse or finger to draw your signature above

Date*

Only The Faculty Sponsor May Sign And Submit This Form

If the PI is a student, click the Save and Resume Later link below and enter the Faculty Sponsor's email address. The Faculty Sponsor will then be responsible for reviewing this Amendment/Continuation/Closure request before signing and submitting it.

If you are the Faculty Sponsor, please review this form, sign below and click the
Submit IRB Amendment / Continuation / Closure Form button below.

Faculty Sponsor Signature*

[clear]

Use your mouse or finger to draw your signature above

Date*