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IRB #:
## Instructions
Use this form to request IRB approval of the following:
Proposed changes to your current IRB-approved protocol.
A proposed change which impacts an individual subject but does not change the overall protocol (i.e., exception and deviation).
## Do NOT use this form:
To report a change to the currently approved protocol which has already been implemented without prior IRB approval.
In emergency situations involving unanticipated problems involving risk to human subjects or others (contact ORI staff immediately at 502-597-6530).
To close a study or to report that a study has been completed (contact ORI).
## Please be sure to
• Revise consent and assent forms, as needed, based on the proposed changes.
Complete and attach appropriate forms.
If you are adding new study personnel, confirm that all new members have completed the mandatory human-subject-protections CITI training BEFORE you submit your modification request.
Have the PI sign on the line provided at the top of the form (next page).
• Attach two copies – one marked and one clean – of all documents affected by the modification (i.e., consent form). On the track-changes copy, underline or highlight each change being made.
Allow ample time for processing this modification request. NOTE: changes may not be implemented prior to receiving IRB approval.
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The quick brown fox jumps over the lazy dog.
## PI Signature
Date
## Modification Details
## 1 Address change for protocol correspondence?
If yes, indicate new address:
Yes
6 No
## 2 Study Title:
Title change?
6 Yes
6 No
If yes, indicate new title:
3 Is this a one-time request for a deviation from the currently approved protocol, or an exception to the currently approved enrollment criteria?
Yes No
## 4 Consent / Assent Form change?
6 No
If yes, be sure changes are reflected in all revised consent/assent documents and any applicable HIPAA documents.
## 5 Check one:
6 This modification does NOT increase risk to study participants.
6 This modification may or will increase risk to study participants.
6 Is this modification request due to an Unanticipated Problem or Adverse Event?
Yes No
7 In your professional opinion, does this modification involve information that might relate to a subject's willingness to continue to take part in the research?
Yes No
If yes, state how the information will be communicated to subjects (i.e., re-consent, send letter, etc.):
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# Modification Request Form
### 8. Changes Made To — check all that apply and attach appropriate documents
## Form A: General Information Sheet
Anticipated Project End Date
□ Estimated # of Subjects
☐ Subject Population
□ Vulnerable Subject Population
Impaired Consent Capacity
□ Children age 17 or less
Pregnant Women
□ Prisoners
□ Other vulnerable population
□ Funding / Support
□ Study Personnel
□ Other – Describe:
## Form B: Research Description & Appendices
□ Objectives
Inclusion / Exclusion Criteria
☐ Subject Recruitment
□ Procedures / Materials
Research Procedures
Grant Application
□ Sponsor Protocol; Investigator Brochure
Waiver of Informed Consent
Waiver of Documentation of Informed Consent
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## Describe Each Modification
REQUIRED: For each proposed modification, describe the currently approved procedures, forms, etc., then summarize the proposed change, addition, etc. Include a justification for the modification request. Add additional sheets if necessary.
## Example
Currently Approved: study staff as listed on attached SP List Template.
Proposed Revision: add Jane Doe, MD, as co-investigator. Dr. Doe has completed human-subject-protections training, is a new faculty member who will work with subjects on this protocol, and is authorized to obtain consent.
## 1 Currently Approved
## Proposed Revision
## 2 Currently Approved
## Proposed Revision
## 3 Currently Approved
## Proposed Revision
