REQUIR
IRB Continuing Review Form
INSTRUCTIONS: In order to conduct a thorough continuing review the IRB requires submission of this
form and an updated Protocol Form* reflecting the current research personnel, procedures, etc., and if
recruitment is ongoing or if there is any possibility of future recruitment, a copy of any Consent
Documents and any Recruitment materials (flyer, notice, advertisement, etc.).
Changes may be made to the protocol in conjunction with this continuing review; a separate Amendment
Form does not need to be submitted. To make changes that were not previously approved by the IRB
please make revisions to the Protocol Form and any supporting documents and highlight the new
information. Also list changes on this form (“Current Changes to Protocol” section).
*Protocol Form refers to any one of the following: Protocol Summary Form, 3-Year Continuing Review Form, Expedited
and Full Review Form
PI/Project Information
Principal Investigator:
Department:
Phone:
E-mail:
@marquette.edu
FOR STUDENTS – Name of Faculty Advisor:
Project Title:
Protocol Number: HR-
REQUIRED
Today’s Date: Click here to enter a date. REQUIRED
By submitting this form, the Principal Investigator, and if applicable, faculty advisor, certify that this
Continuing Review Form and supporting materials are an accurate reflection of the current research
procedures, research personnel, and research progress, that all relevant information regarding risk level
and adverse events has been disclosed, and understand that research for this project may only continue if
renewed approval is granted prior to the protocol expiration date.
Submission Instructions: Email this completed form to orc@mu.edu with the following subject line:
Continuing Review Submission for [first and last name of PI], HR-[XXXX]
 In the body of e-mail, include the title of the study and a list of attachments (MUST include
Protocol Form and any consent/recruitment materials if subject contact is ongoing).
 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, please contact the ORC by phone (414) 288-7570 or email
(orc@mu.edu) to verify receipt.
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: orc@mu.edu, Web: www.mu.edu/orc/irb
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1. NEED FOR CONTINUING REVIEW
Please check which of the following currently apply or will apply in the future to your expedited or full
review research protocol:
Enrolling new research subjects
Intervening or interacting with research subjects
Obtaining or accessing identifiable data
Analyzing or writing using identifiable data
If none of the above apply to your protocol, please complete the Final Report Form
2. PROTOCOL STATUS
Active - project ongoing with no changes
Active - project ongoing; protocol changes are highlighted in the attached documents
Currently Inactive - project was initiated but is presently inactive
Inactive - project never initiated but anticipated start date is:
3. ANTICIPATED PROJECT END DATE - REQUIRED: Click here to enter a date.
4. RESEARCH PROGRESS
Provide a concise summary of protocol progress to date (stage of recruitment, number of aims
started/completed, preliminary findings, etc.). If the project is inactive, or if delays or difficulties have
arisen related to recruiting, research procedures, or other aspects of the research, please describe.
5. EVIDENCE OF INCREASED RISK
Has any information appeared in the literature, or evolved from this or similar research, that might
affect the IRB's evaluation of the risk/benefit analysis of human subjects involved in this protocol?
No
Yes
If Yes, please explain:
6. UNANTICIPATED PROBLEMS, ADVERSE EVENTS, SUBJECT COMPLAINTS
Indicate which of the following have occurred
Minor deviation from approved protocol that did not affect the welfare of a human subject
Change implemented without prior IRB approval to eliminate an immediate risk to subjects
Noncompliance with IRB approved protocol
Unanticipated problem that affected the welfare of a human subject
Adverse event
Complaint from research subject
None of the above
If any of the above occurred since the last continuing review, please describe. Indicate whether or not
the incident was reported to the IRB and any follow-up action taken:
7. CHANGES TO THE APPROVED RESEARCH PROTOCOL
Indicate what, if any, changes have been implemented since study inception.
No changes since study inception
*Changes were made via IRB approved amendment(s) since the last continuing review
Changes were made via IRB approved amendment(s) prior to the last continuing review
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: orc@mu.edu, Web: www.mu.edu/orc/irb
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*Briefly describe amendments approved since the last continuing review:
8. CURRENT CHANGES TO PROTOCOL
Changes can be made to the protocol in conjunction with this continuing review. Instead of submitting
a separate Amendment Form, please make the changes on the Protocol Form and highlight the new
information.
Are any changes being made to the protocol that were not previously approved?
No
Yes
If Yes, please briefly describe changes submitted with this Continuing Review (list Question #s where
revisions were made on the Protocol Form, describe changes to consent documents or other supporting
materials, etc.):
9. SUBJECTS/RECORDS/SPECIMENS
Total number of subjects/records/specimens approved by IRB
(This number can be found on your approval letter)
Total number of subjects consented OR Total number of records or
specimens used for research purposes since study inception
Number of subjects consented OR Number of records or specimens used
for research since the last continuing review
Please note that there may be circumstances under which the IRB will require additional information regarding subjects,
specimens or records such as gender, race, ethnicity, age, etc.
10. SUBJECT WITHDRAWAL/REMOVAL
Have any subjects withdrawn from this study, or been removed from the study by research personnel,
in the last year? A subject is classified as withdrawn or removed from the study if consent occurs but
study participation ends before completion.
No
Yes
If yes, please list the number of subjects withdrawn/removed and reason(s):
11. DATA & SAFETY MONITORING
Does your project have a Data & Safety Monitoring Plan?
No
Yes
If Yes, please describe the monitoring procedures, whether any risks to subjects were
identified that have not previously been reported to the IRB, and if any modifications to
study procedures have been or should be made based on results of monitoring activities:
11. PUBLICATION
Have any publications been generated from this project?
No
Yes
Number of articles/manuscripts submitted or in development:
12. FUNDING
Grant or Contract Funded (external only):
No
Yes
Funding is pending or intend to apply for funding in the future
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: orc@mu.edu, Web: www.mu.edu/orc/irb
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If No, skip to Question 13. Otherwise answer questions 1-4 below:
1. Sponsor/Source of funding or potential funding:
2. Is this project funded by any Health & Human Services or other Common Rule federal agency?
Yes*
Funding is Pending*
Intend to apply in the future
NO INTENT to apply for future federal funding
3. Is this projected funded by CTSI?
No
Yes*
Funding is Pending*
4. Have you registered your project with the Office of Research and Sponsored Programs
(ORSP)?
Yes
No
If Yes, Please list your Marquette ORSP Reference #:
(numbers are formatted by year and a three digit number YY-XXX, ex. 12-301)
*For studies that are federally grant funded (including CTSI), submit a copy of the grant application along with this
form if it was not previously submitted to the IRB.
13. CONFLICT OF INTEREST
Since initial approval, have any potential financial conflicts of interest in this study arisen that should
be disclosed?
Yes
No If Yes, Please explain:
14. ADDITIONAL INFORMATION
Please list any additional information the IRB should consider during continuing review of this
research protocol (optional):
15. ELECTRICAL SAFETY TESTING INFORMATION
Does your study involve any equipment that requires electrical safety testing per HRP Policy 98.106?
Yes
No
If Yes, please list equipment that requires testing, and the next due date for testing:
16. SUPPORTING DOCUMENTS
Indicate which of the following documents are being submitted with this form:
Protocol Form* (Required)
Consent Document(s) – select one answer
Recruitment/Consent Ongoing – Total number of consent documents submitted:
Recruitment/Consent Complete – No consent document submitted
Not applicable – Research does not involve a consent document
Recruitment Materials – select one answer
Recruitment Ongoing – Total number of flyers/notices/advertisements submitted:
Recruitment Complete – No recruitment documents submitted
Not applicable – Research does not involve recruitment documents
Reportable Event Form
Electrical Safety Testing
Other – please list:
*Protocol Form refers to any one of the following: Protocol Summary Form, 3-Year Continuing Review Form,
Expedited and Full Review Form
Marquette University Office of Research Compliance, 560 N. 16th Street, Room 102
Phone: 414-288-7570, Fax: 414-288-6281, Email: orc@mu.edu, Web: www.mu.edu/orc/irb
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