Fillable Irb Approved Protocol Extension Form (Southern Utah University)

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Irb Approved Protocol Extension Form (Southern Utah University)

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APPROVED PROTOCOL EXTENSION
FORM
Southern Utah University
Institutional Review Board
APPROVED PROTOCOL EXTENSION FORM
Information entered into this form may be lost if this file is not first
downloaded (i.e., saved to a local device) and then opened with Adobe
Reader or Adobe Acrobat prior to the entry of any information.
Name of Principal Investigator E-mail
Phone Number Department
College/School
Faculty Supervisor (If Applicable) E-mail
Phone Number Department
College/School
Project Title
Original Approval Date
Date of Last Approval (if Applicable)
Status of Research Project was:
Exempt Expedited Full-board Review
Current State of Research Project:
Active - project is ongoing
Currently inactive - project was initiated but is presently inactive
Inactive - project was never initiated
Total number of subjects
tested to date
Total number of subjects
withdrawing their
participation once
initiated
Total number of subjects
tested since the last IRB
review
If Applicable/Known, Explain the reason(s) why subjects withdrew.
Problems/Adverse Events
No problems/adverse events have occurred
One or more problems/adverse events have occurred
If There Were Problems/Adverse Events
All have been reported to the SUU IRB
One of more problems have not been reported to the SUU IRB (Please complete and
attach the Human Subjects Incident Report Form)
Relevant Literature/Findings:
Describe any recent literature or findings since the last IRB review which may affect participants’
willingness to participate, risks, and/or vulnerability status. If any of the proposed changes
increase the risk level and/or increase participants vulnerability status, you must provide explicit
rationale and justification for the change, and a means by which the effect of these changes
may be minimized. This information must be included in the informed consent document/script.
Changes to Project:
Indicate which of the following changes (modifications or addendum) you would like to make, if
any.
No changes requested
Project personnel-If new PI or Faculty Supervisor IRB Training Certificate must be
attached or on file.
Test Location- If off campus permission letter from site must accompany this application
Testing material or apparatus
Incentives/compensation for participation
Procedures
Informed consent
Other: please describe
For each change requested above, indicate what/how you proposed initially (i.e. that which was
approved) and the modifications/addendum you would now like to make. For each change,
address what if any impact the change might have on a) risks and benefits to the participants
and others, and b) the vulnerability status of participants.
Informed Consent:
Paste or attached a printed clean copy of the currently approved informed consent document/
script and the proposed document/script.
If informed consent requirements were previously waived by the IRB committee, summarize the
reason(s) below.
The information provided in this report is accurate to the best of my knowledge. I assure the
IRB that my work involving human participants has been conducted in accordance with policy
6.20 of Southern Utah University, and within the previously approved protocol and conditions, if
any, imposed by the IRB.
I agree with the above statement
Principal Investigator's Signature (Typed Signature) Date
Faculty Supervisor's (Typed) Signature (If Applicable)
Please submit this form via email to irb@suu.edu along with any applicable
attachments or supplemental materials.
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Irb Approved Protocol Extension Form (Southern Utah University)

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Completed 23 July 2020

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