Ohio University
Institutional Review Board
Project Amendment/Revision Form
Federal regulations require IRB approval prior to implementing proposed changes to
research projects. Such changes include any change to the originally approved proposal,
including, but not limited to changes in number of participants, changes in
recruitment/research procedures, and changes in supporting documents (consent form,
debriefing form, questionnaires, advertisements, etc.).
Please complete this form, and attach all revised documents or supporting information,
with changes clearly highlighted (preferably in yellow).
Proposal #
Date
Proposal Title
Primary Investigator Information
Name
Department
Email
Phone
Study Status
Active (currently in progress)
Number of participants currently enrolled _______
Project on Hold (pending approval of this amendment)
Project not yet started (no participants enrolled)
Closed to new participant entry (data analysis/intervention occurring)
1. Describe the proposed change(s) and why they are being made.
Please note: If a new investigator is added, a revised page one of the IRB Project Outline Form, a
signed Investigator Assurance page of the Project Outline Form, and proof of training is required.
2. Describe how, if at all, the proposed change(s) affect the risk(s) of the study.
3. Describe how, if at all, the proposed changes affect the benefit(s) of the study.
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Yes
No
4. Does the revision affect the consent/assent document(s)?
If YES,
Will any participants need to be re-consented as a result of the changes?
Yes
No
If YES, please describe the process to be used.
Include two copies of the revised consent/assent document(s), one with changes
highlighted, and one without highlighting.
Primary Investigator Signature
Date
Advisor Signature
Date
*Please note that approval of an amendment does not change the expiration date of the
study.
Please submit the completed project outline form, appendices, and scanned signature
pages, preferably by email, to compliance@ohio.edu or in person to:
Office of Research Compliance
117 Research & Technology Center
Ohio University
Athens, OH 45701-2979
If you have questions, call 740-593-0664, visit the website at
www.ohio.edu/research/compliance, or email compliance@ohio.edu.
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