Fillable Instructions: Federal regulation requires that changes to approved (Broward College)

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Instructions: Federal regulation requires that changes to approved (Broward College)

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IRB-AF – (11/13) Page 1 of 2
Instructions: Federal regulation requires that changes to approved protocols be submitted to the IRB for review and
approval prior to the implementation of these changes.
Section I General Study Information
Title of Study:
IRB Protocol #:
Approval Date:
Name of Primary Investigator (PI):
PI Email:
PI Phone:
Section II Amendment Information
Please select the type of amendment you are requesting (select all that apply):
Change in protocol (design, methods, procedures, etc.)*
Change to number of participants and/or selection criteria
Change in recruitment materials (flyers, emails, compensation, etc.)*
Change in study materials (surveys, questionnaires, etc.)*
Change in consent form*
Change in research personnel
Other changes
*Please attach all revised/new documents with the changes highlighted
For each item selected above, describe the changes being made and rationale for the proposed changes.
IRB AMENDMENT FORM
IRB-AF – (11/13) Page 2 of 2
Do the requested changes increase the risks to participants?
Yes No
If yes, please explain:
Are any of the changes the result of an unexpected or adverse event?
Yes No
If yes, please explain:
If yes, did you promptly report these events to the IRB via the Adverse Event Report Form?
Yes No
If no, you must submit an Adverse Event Report Form to the IRB along with the IRB Amendment Form.
Are the changes expected to affect participants’ willingness to participate in the research?
Yes No
If yes, please explain:
Section III CERTIFICATION
I certify that the information provided entirely and accurately describes the proposed changes to the research
protocol. I agree not to make any changes to the project during the approval period until IRB approval for
these changes has been obtained, except in the case of immediate harm to participants.
PI name:
PI signature:
Date:
Supervisor name (if applicable):
Supervisor signature (if applicable):
Date:
Completed IRB Amendment Forms should be submitted with required documents to irb@broward.edu.
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Instructions: Federal regulation requires that changes to approved (Broward College)

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Completed 18 August 2020

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