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Proposed Changes To A-previously Approved Protocol (Southern Utah University)

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PROPOSED CHANGES TO A
PREVIOUSLY APPROVED
PROTOCOL
Southern Utah University
Institutional Review Board
PROPOSED CHANGES TO A PREVIOUSLY APPROVED PROTOCOL
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.
This form should be used to obtain approval for changes (modifications or addendums) to a
previously approved IRB proposal. Examples of changes include but are not limited to: a change in
the principal investigator (or supervisor if PI is a student), changes to the materials list, participant
selection and/or recruitment, incentives/compensation for participation, procedures, and/or informed
consent. Approval must be obtained prior to initiating these changes, unless they are to eliminate
an immediate risk to participants or others. If this is the case, the IRB chairperson and the director
for the office of sponsored research must be contacted immediately.
Note that a change in the number of research participants does not require approval unless
participants meet the definition of vulnerable and/or the proposal was judged to involve greater than
minimal risk. If either applies, only a decrease in the number of participants may be made without
first seeking approval.
Name of Principa
l Investigator
E-mail
Phone Number Department
College/School
Faculty Supervisor (If Applicable) E-mail
Phone Number Department
College/School
Project Title
Original Approval Date
Status of Research Project was:
Exempt Expedited Full-board Review
PROTOCOL SUMMARY: Summarize in 100-250 words what you set out to find and how
you went about doing it.
PROPOSED MODIFICATIONS:
List all desired modifications/revisions by indicating what/how you proposed initially (i.e. that
which was approved) and the modifications you would now like to make. For each modification/
revision 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.
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.
PROPOSED ADDENDUMS:
List all desired addendums to the previously approved proposal. For each addendum, 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.
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.
When/where applicable, paste any new test materials, informed consent documents, etc., or
attached them to the signed, submitted copy of this document.
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 proposal via email to irb@suu.edu along with any applicable
attachments or supplemental materials.
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Proposed Changes To A-previously Approved Protocol (Southern Utah University)

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Completed 23 July 2020

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