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AMENDMENTCHECKLIST (Marquette University)

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Page 1 of 2 November 19, 2012
Institutional Review Board
Office of Research Compliance
Amendment Checklist
V.1
AMENDMENT CHECKLIST
Directions: The purpose of this checklist is to provide documentation of determining whether a project meets the
criteria for Expedited review for minor changes to previously approved research and amendments requiring Full
Board review. Please contact the IRB staff if you are unable to review this study or have a conflict of interest related
to this research or review.
I. GENERAL
Project Title:
Principal Investigator:
MU IRB#: HR-
Reviewer:
Review Date:
II. AMENDMENT REVIEW
1.
Does the investigator give an adequate rationale for the changes requested in
the proposed amendment?
☐
☐
☐
NA
2.
Have all applicable documents been submitted with the changes incorporated
to maintain consistency between the protocol, the VA Central IRB Application,
and any informed consent or HIPAA authorization documents?
☐ YES ☐ NO ☐ NA
3.
Will the change(s) adversely alter the overall risk-benefit ratio?
☐
☐
☐
NA
4.
Will the change(s) potentially affect the willingness of current participants to
remain in the study or the willingness of potential participants to enroll in the
study?
☐
☐
☐
NA
5.
Will any added procedures prevent the research from falling into Expedited
categories (1)-(7)? (E.g., addition of X-Rays).
☐
☐
☐
NA
6.
Informed consent will be sought and appropriately documented from each
prospective subject or the subject’s legally authorized representative. If a
waiver to obtain, document or alter the requirements of informed consent is
being requested, there is adequate justification to do so.
☐
☐
☐
NA
7.
Is there an adequate plan for informing the participant of these changes and
re-consenting of participants if required?
☐ YES ☐ NO ☐ NA
8.
Do the proposed change(s) require a more frequent continuing review interval
than is currently established for this project?
☐
☐
☐
NA
III. DETERMINATION
☐
Approve with no changes or stipulations
☐
Disapprove (Only for Full Board)
Page 2 of 2 November 19, 2012
☐
Approve with the following changes or stipulations:
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Completed 24 July 2020

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