The University of Toledo
Department for Human Research Protections
Social, Behavioral & Educational Institutional Review Board
Office of Research, Rm. 2300 University Hall
Mail Stop 944; Toledo, Ohio 43606-3390
Phone: 419-530-2844 Fax: 419-530-2841
Social, Behavioral & Educational Application for Continuing Review
STATEMENT OF POLICY
It is the policy of the University of Toledo’s Social, Behavioral & Educational Institutional Review Board (IRB) that in the
continuing review of ongoing research, the entire study will be reviewed to ensure the continued protection of the rights
and welfare of the human subjects. The SBE IRB follows, at minimum, the regulations set forth in Title 45 Code of
Federal Regulations Part 46, Section 46.111 (45 CFR 46.111) as the criteria for continuing review. The Continuing
Review process must be no less stringent than the initial review.
The Principal Investigator is responsible for timely submission of a continuing review application to prevent any lapse in
IRB approval. Federal regulations do not provide for exceptions to the requirement for continuing review. Therefore,
failure by the Principal Investigator to ensure timely IRB review is a serious matter that may lead to suspension or
termination of the study. Continuing Review and approval are required until data analysis is complete.
A. STUDY INFORMATION (Tab or click on shaded box to complete form)
SBE IRB Protocol #
Expiration Date:
Project Title:
Principal
Investigator
Type of Review:
Convened
Expedited
Principal
Investigator
Phone:
Email:
Student:
Phone:
Email:
B. ASSURANCES
I certify that the information provided in this application is complete and accurate.
 I understand that as Principal Investigator, I have the ultimate responsibility for the protection of the rights and welfare of human
subjects, and the strict adherence to any study-specific requirements imposed by the IRB.
 I agree to comply with all IRB and Institutional policies and procedures, as well as with all applicable Federal, State, and local laws
and regulations regarding the protection of human subjects in research and the conduct of clinical research.
 I also agree to the following:
1. to accept responsibility for the scientific and ethical conduct of this research study;
2. to obtain prior approval from the Institutional Review Board before amending or altering the research protocol or implementing
changes in the approved consent form, study sites or study personnel, recruitment procedures;
3. to immediately report to the IRB any serious adverse reactions and/or unanticipated effects on subjects which may occur as a
result of this study;
4. to train study personnel in the proper conduct of human subjects research;
5. to complete the Continuing Review and Final Report Forms required by the SBE IRB;
6. to adhere to the standards of Good Clinical Practice (GCP), developed by the International Conference on Harmonization (ICH)
where appropriate.
Name of Principal Investigator
Date:
Signature of Principal Investigator
Continuing Review Request
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08/15/2007
C. PROGRESS REPORT
Please note: Continuing Review and approval are required until data analysis is complete.
1. Status of Study
Recruitment
of Human
Subjects:
Complete
Not Yet Complete  Anticipated completion date:
Reporting:
Complete
Not Yet Complete  Anticipated completion date:
Data
Acquisition:
Complete
Not Yet Complete  Anticipated completion date:
Long-term
Observation/
Follow-up:
(if applicable)
Complete
Not Yet Complete  Anticipated completion date:
Data
Analysis:
Complete
Not Yet Complete  Anticipated completion date:
Thesis/
Dissertation
Defense
(if applicable)
Complete
Not Yet Complete  Anticipated completion date:
2. Enrollment Information
Total number of subjects approved by the IRB (in original
application or subsequent amendment to increase enrollment):
Number of subjects enrolled since last progress report:
Total number of subjects enrolled since the start of the study at UT
3. Participant Activity Status
Please report the number of subjects at UT in the following categories.
The numbers must add up to equal the total number of subjects enrolled since the start of the study.
Please check your math before submitting this form.
Currently Active in Study
Withdrawn from Study
Follow-up Data Collection Only
Lost to Follow-up
4. Adverse Events Complications, Study Withdrawals: ANSWER EVERY QUESTION
In the past approval period, did any deviation/violation/participant non-compliance from the approved
protocol occur? If yes, you should have submitted the appropriate form to the SBE IRB office. If you
have not – fill out a Deviation/Violation/participant Non-compliance Reporting Form (available on the
SBE IRB website) and attach it to this continuing review.
Yes
No
In the past approval period, did any problems occur in obtaining or documenting informed consent
(i.e., problems with subject understanding, high refusal rate, etc.)
Yes
No
If yes – explain
In the past approval period, did you withdraw any subject(s) from your study because of a problem or
complication?
Yes
No
If yes - explain
Continuing Review Request
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08/15/2007
In the past approval period, did any subject(s) withdraw themselves from your study?
Yes
No
If yes - explain
In the past approval period, has anything occurred since the last IRB review that may have altered
the risk/benefit relationship?
Yes
No
If yes - explain
D. REASONS FOR RESEARCH PROJECT CONTINUANCE
1. Additional Time Required for Completion of Study
I am requesting additional time to continue work on my human subject research protocol.
Current protocol Termination Date
Continuance Date
(not greater than one year beyond current termination date)
What are the specific reasons that you are requesting additional time?
2. Amendment Requests
I am requesting an amendment to my human subject research protocol.
Note: Approval by the SBE IRB is required for any changes to your approved protocol. This may include changes to
your protocol:
 Methods and Procedures
 Risks and Benefits
 Performance Sites
 List of Approved Investigators
 Human Subjects (number, sub-populations, etc.)
 Recruitment Procedures
 Confidentiality
 Conflict of Interest
 Any Other Requested changes
To request an amendment to your approved protocol, you must attach an Amendment Request to this form –
specifically documenting each proposed change to your approved protocol.
Continuing Review Request
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08/15/2007