Protocol Amendment Form

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Human Research
REQUIRED
Protocol Number: HR-
Institutional Review Board
Protocol Amendment Form
Use this form for modifying an approved expedited or full review protocol. If you are ONLY making personnel
changes (add, remove, change role) please complete the Amendment Form – Personnel Change.
For exempt protocols, this form is only required if you are making a major change or a change that increases
risk, all other changes may be emailed to [email protected] for review.
PI/Project Information
Principal Investigator:
Department:
Phone:
E-mail:
@marquette.edu
FOR STUDENTS – Name of Faculty Advisor:
Project Title:
Date Submitted:
Instructions:
1. Enter Protocol Number (upper right corner of this form)
2. Enter PI/Project Information above
3. Complete this form. If you are modifying consent documents, recruitment materials, research tools, etc.
please indicate all changes by using track changes, highlights, bold font, or a similar means to
distinguish between previously approved information and current requested changes. Documents
submitted without distinguishing revisions that have been made may be returned to the
researcher. Recruitment and consent materials should be submitted in an editable format such as a
Word document.
Submission Instructions: Email this completed form and any supporting documents as attachments to
[email protected] with the following subject line:
Amendment Submission for [first and last name of PI], HR-[XXXX]
 In the body of e-mail, include the title of the study and an itemized list of attachments.
 The email address of the sender must be the Principal Investigator’s Marquette email.
 If the PI is a student, the faculty advisor must be cc’d.
Once submitted, the ORC will e-mail back a response of receipt. If you do not receive an e-mail
confirmation of submission within 3-5 days of submission, please contact the ORC
by phone (414) 288-7570 or email ([email protected]) to verify receipt.
1. AMENDMENT DESCRIPTION (Check all that apply)
Changes to currently approved research procedures
Changes to currently approved forms (consent, advertisement, survey, etc.)
Add additional research participants (subjects)
Add or change research personnel
Add a research location (attach permission or approval letter)
Other (describe under question 5)
2. RISK ASSESSMENT
This revision does not increase risk to participants enrolled in the study (expedited review possible).
This revision does increase risk to participants enrolled in the study (include specific details in the
revision description).
3. SUBJECT RECRUITMENT – Complete only if modifying the number of subjects
a.
b.
c.
d.
e.
Original protocol approved for
number of subjects.
Previously approved amendments have added
number of subjects.
Current request is for an additional
number of subjects.
Total number of subjects for this protocol:
(a + b + c)
Explain how you determined the number of additional subjects required to complete this study:
4. PROJECT PERSONNEL/ASSOCIATES
Provide the names, titles and affiliations of all investigators you wish to ADD to this protocol (students
included). Please use an attachment if more space is required.
Verify that any personnel to be added have completed NIH Protecting Human Research Participants
training.* To see if a certificate is on file with the ORC access the IRB Training Lookup page on
SharePoint. This form cannot be processed until certificates are on file for all MU investigators.
*Marquette also accepts CITI and equivalent human subjects training. For investigators involved with the protocol who are not
affiliated with Marquette, the Marquette IRB requires that the PI ensure a proper level of training.
If training is not already on file, follow the instructions for formatting certificates. New certificates may be
attached with this form, or sent separately to [email protected]
Name
Institution
Status
(Faculty,
Grad.,
Undergrad.,
etc.)
Project Role (list Action new role if role is Add/
changing)
Remove/
(Co-PI, Consultant,
Change
Research Assistant,
Role
etc.)
Training
(Attached,
On File w/
MU ORC,
N/A)
Marquette University, IRB Amendment Form
Revised 09/13/2013
5. REVISION/AMENDMENT DESCRIPTION
Describe in detail below the changes you are requesting to your approved protocol. Include a detailed
explanation of the reason(s) you are seeking to modify your previously approved research project. In
addition, explain how new information from this amendment will be communicated to currently enrolled
participants (i.e. will participants be re-consented):
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: [email protected], Web: www.mu.edu/orc/irb
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