University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
INSTITUTIONAL REVIEW BOARD
REQUEST FOR CONTINUING REVIEW OF HUMAN RESEARCH
SOCIAL/BEHAVIORAL RESEARCH
PRINCIPAL INVESTIGATOR:
PROTOCOL TITLE:
PROTOCOL #:
EXPIRATION DATE:
REVIEW BOARD:
SPONSORING AGENCY:
Please provide the following information/documents that pertain to the above referenced project when returning this form. If
you are unsure of the review category, see the guidance posted on the IRB website or contact an IRB Administrator prior to
making this determination. www.upenn.edu/regulatoryaffairs.
If the project is complete with no subjects in follow up and all data analysis that may require contact with records or
specimens linked to privately identifiable information is complete, or the project is being closed, please provide this form
along with a brief final report.
To assure timely IRB approval, please submit the requested materials to the Office of Regulatory Affairs at least eight
weeks before the protocol expiration date.
NOTE: No research related activities may occur after the protocol expiration date unless the PI contacts the Office
of Regulatory Affairs and the IRB Executive Chair (or authorized designee) determines that it is in the best interest
of subjects to continue during the lapse in IRB approval.
The information requested is needed for a comprehensive review, monitoring and oversight of research involving human
subjects. Contact with the sponsor to obtain information for multi-center projects may be necessary.
Qualifies for EXPEDITED REVIEW: PROTOCOL
N/A
http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
Research was initially reviewed by expedited IRB expedited
review. (Refer to initial approval letter.)
Requires Review by Convened IRB:
N/A
Research initially reviewed by the convened IRB (i.e., full
board). Subjects have been enrolled and recruitment or
enrollment of subjects continues.
Research initially reviewed by the convened IRB. Study is
no longer enrolling, but subjects still receive research related
interventions.
Please check one of the following:
Study is currently enrolling
Study is closed to enrollment
Research initially reviewed by the convened IRB but deemed by
the IRB to be eligible for expedited review.
Other (e.g., “prime protocol”)
********************************************************************
Research initially approved by a convened IRB and:
No subjects enrolled at Penn; but new risks identified that
pose greater than minimal risks to subjects.
**************************************************************
Research initially reviewed via an expedited mechanism
but a later amendment increased the risks to greater than
minimal.
Research is permanently closed to new subject accrual, all
subjects have completed all research-related interventions, and the
research remains active only for follow-up (i.e., the only remaining
research related activities qualify for expedited review).
Research activities are limited only to data analysis that may
require contact with records or specimens linked to privately
identifiable information.
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Request for Continuing Review (SBS)
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
No subjects have been enrolled at Penn and no additional risks
have been identified. "No subjects have been enrolled at Penn"
means that no subjects have ever been enrolled at Penn or sites
under the jurisdiction of the Penn IRB regardless of the location of
the recruitment site. The criterion that "no additional risks have
been identified" is interpreted to mean that neither the investigator
nor the IRB at a particular site has identified any additional risks
from any site or other relevant source. “Enrolled” means that the
subject has consented to participate in the study.
Study Complete. Close the
study
Enrollment and follow up are complete and no further contact with participants/identifiable records/or
identifiable specimens is anticipated. Indicate why (e.g., research related activities and data analysis
are complete, required number of subjects reached, issues with protocol safety, etc.)
A separate final report may be provided.
EXPEDITED REVIEW SUBMISSION REQUIREMENTS
Collated Packages Arranged in the Following Order:
CONVENED IRB REVIEW SUBMISSION
REQUIREMENTS
Collated Packages Arranged in the Following Order:
Continuing
Review Form
Continuing
Review Form
1 copy
1 Copy Currently Approved Protocol
(if any)
1 Copy Updated Protocol Summary
(Section II of the IRB Application Form)
Note: The protocol summary must
include all changes approved by the
IRB since the last submission.
Current
Protocol
Informed
Consent
Form
Informed
Consent
Form
2 Copies
N/A
Changes
Amendments
Attachments,
if applicable
Current
Protocol
If proposing changes or amendments to
any IRB approved documents, submit a
separate request for amendment.
Summary of protocol modifications
approved since last continuing review
Conflicts of Interest Disclosure Form
(if unreported changes have occurred
since last submission.)
Unanticipated problems not reported
to the IRB
Complaints from subjects or others
Latest DSMB report
Changes
Amendments
Attachments
if applicable
15 Copies
3 Copies Currently Approved Protocol
(if any)
15 Copies Updated Protocol Summary
(Section II of IRB Application Form)
Note: The protocol summary must include
all changes approved by the IRB since
the last submission.
15 Copies
N/A (e.g., closed to enrollment or
research activities limited to data analysis)
If proposing changes or amendments to
any IRB approved documents, submit a
separate request for amendment.
Summary of protocol modifications
approved since last continuing review
Conflicts of Interest Disclosure Form (if
unreported changes have occurred since
last submission.)
Unanticipated problems not reported to
the IRB
Complaints from subjects or others
Latest DSMB report
Investigator
Brochure/
Package
Insert/ Device
Manual
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3 Copies of current versions
N/A
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
Contact Person:
I. Contact Information
E-mail Address:
Phone/Beeper:
Fax:
Mailing Address:
II. Protocol Information
Progress Report
If summary information is not provided in the section above, please provide a progress report
Attached
detailing study activity during the last approval period.
IRB Approval is current
IRB approval is expired or will expire before the scheduled IRB review.
NOTE:
If the IRB approval for the protocol has expired or will expire before the scheduled IRB review, confirm that no research
related activities occurred/will occur without approval from the IRB unless the PI contacted the Office of
Regulatory Affairs and the IRB Executive Chair (or authorized designee) determined that it is in the best interest
of subjects to continue during the lapse in IRB approval. For example, in a clinical trial there are (1) subjects who
are enrolled but not on intervention, (2) subjects who are on intervention, and (3) subjects who have completed the
intervention phase and are in follow up. The IRB Executive Chair must evaluate each of these groups separately
regarding continuation of participation in the research after IRB approval has expired.
III. MODIFICATIONS
Are there any changes to the protocol or consent form that were not previously reported to the IRB?
 If YES, attach a request for approval of those modifications.
Yes
Modification materials attached
Modification materials will be sent as a separate submission
No
IV. SUBJECT ENROLLMENT
1. Target enrollment at Penn
NOTE: Enrolled at Penn means participants who are under the jurisdiction of the
Penn IRB regardless of the location of the recruitment site. For records review or
analysis of data sets, indicate the number of cases studied.
2. Target enrollment at participating centers (for multi-center study)
Not applicable
3. Summary of Subjects
Total # of subjects who provided consent
# subjects determined to be ineligible
# subjects currently active/on study
# subjects withdrawn at subject’s request
# subjects withdrawn at the request of the investigator
# subjects withdrawn due to adverse events/unanticipated problems
# subjects lost to follow-up
# subjects no longer participating for other reasons
# subjects who have completed the study
4. Number of subjects enrolled at participating centers (if known)
Not applicable
5. Number of subjects enrolled at Penn since the last continuing review.
NOTE: “Enrolled” means that the subject has consented to participate in the study.
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
6. Federal regulations require IRBs to gather information about ethnic
backgrounds. Estimate the ethnic breakdown of subjects enrolled at Penn:
American Indian or Alaskan Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
Hispanic or Latino
White
Other
Unknown/Not Reported
Estimate the gender of subjects
enrolled at Penn:
Male
Female
Unknown/Not Reported
TOTAL
TOTAL
7. If applicable, please provide a brief summary of any difficulty you experienced obtaining/retaining subjects or obtaining
informed consent during the entire approval period. Additionally, please indicate if there have been any complaints
about the research.
V. UNANTICIPATED PROBLEMS POSING RISK TO SUBJECTS OR OTHERS
1. Since the last IRB review, have there been any unanticipated study-related events that have not been previously
reported to the IRB?
Yes
No If YES, attach a description of the event to this form.
If the events were previously reported → STOP. Do not include these events in the current submission.
Refer to www.upenn.edu/regulatoryaffairs/IRB
2. Since the last IRB review, has the profile of adverse events (in terms of frequency, severity, or specificity) changed
from previous experience or as documented in the research protocol, informed consent document, or investigator’s
brochure?
Yes
No If YES, attach a summary of the changes. IF NO, no additional summaries of events are required.
VI. New Findings
1. Have there been any significant preliminary observations/interim findings during the past approval period?
Yes
No
If yes, please describe below or in the progress report.
2. Does a data monitoring committee (DMC) or data and safety monitoring board (DSMB) exist?
Yes
No
IF YES:
DMC or DSMB report is attached
DMC or DSMB report is pending.
3. Describe any relevant information, including recent literature, or other findings that may affect the risks associated with
this research. If applicable, please describe any required modifications to the consent document.
4. If this study is a multi-site trial, provide a narrative summary of any relevant reports that have been received in the
past year, regardless of whether the report has been previously submitted to the IRB.
VII. Conflicts of Interest
Disclosure of Financial Interests / Continuing Review
A FINANCIAL INTEREST includes any current or anticipated ownership interest or other financial relationship with any
company or entity that sponsors, provides support, or otherwise has a financial interest in the conduct or outcome of this
research protocol (“Outside Organization”). This includes:
 Service on the Outside Organization’s Board of Directors, or as an officer, manager, owner, founder, partner, or in
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006




any other position of authority;
Any ownership interest, stock, stock options, or other financial interest in a non-publicly traded Outside
Organization, or in a publicly traded Outside Organization that exceeds 5% ownership or $10,000 in value, other
than stock/stock options held in a mutual, pension, or investment fund over which the investor has no control with
regard to investment decisions;
Ownership or other financial interest in a drug, device or other product used in this research, or in a competing
product, that is being developed or tested by, or manufactured, supplied or distributed by the Outside
Organization, including, a patent, trademark, copyright, or the receipt or right to receive royalties or other
compensation in connection with the development, licensing and / or sale of the product;
Any personal consulting, lecturing / speaking, service on the Scientific Advisory Board, expert witnessing or other
services provided to the Outside Organization for which the person providing the service receives or has the right
to receive compensation or anything of value; and
Any other financial interest that would reasonably appear to be affected by the conduct or outcome of this research
protocol.
1. Does any person who is responsible for the design, conduct, or reporting of this research protocol have a FINANCIAL
INTEREST, as defined above, including:
 You and your spouse, parents and any children;
 The spouses, parents and any children of any person responsible for the design, conduct, or reporting of this
research; and
 Any corporation, foundation, trust or other entity controlled or directed by any of the above individuals?
Yes
No
2. If the answer to Question 1 is “YES”, was this Financial Interest previously reported to the Conflicts of Interest
Standing Committee?
Yes
No
3. If the answer to Question 2 is “YES”, has there been a change regarding this Financial Interest from what was
previously reported to the Conflicts of Interest Standing Committee?
Yes
No
If you answered “No” to Question 2 or “Yes” to Question 3 above, any person identified with a financial interest must
complete a Confidential Financial Disclosure Statement (“Disclosure”) and include a copy with your IRB submission. To
access the Disclosure, use
The Disclosure and a copy of the IRB submission will be forwarded to the Office of the Vice Provost for Research, Conflicts
of Interest Standing Committee, for review. For guidance regarding requirements for disclosure of financial interests,
please contact the Office of the Vice Provost for Research, sorokai@pobox.upenn.edu.
In addition, for industry-sponsored trials, please attach the documentation submitted to the sponsor as required by 21 CFR
54.1, if applicable.
CERTIFICATION
The principal investigator has reviewed the Financial Disclosure and Presumptively Prohibited Conflicts for Faculty Participating in Clinical Trials and
the Financial Disclosure Policy for Research and Sponsored Projects with all persons who are responsible for the design, conduct, or reporting of
this research; and all required Disclosures have been forwarded with this application. By signing this form the principal investigator and
the person completing the from (if other than the investigator) certify that he/she has disclosed to the IRB all relevant
information concerning adverse events or other issues that might affect the risk-to-benefit analysis of this study.
IRB Quality Improvement through Self-Assessment for Human Research
Purpose:
There are six (6) key areas that are addressed in this quality assurance project which is designed to elicit responses that
provide a snap shot of your research. Please bear in mind this is an effort to address a broad range of social behavioral
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
science research studies. Consequently, some of the materials may not be applicable to your particular project. We may
follow up with you on some of your responses.
Self-Assessment Form for Human Research
I. Informed Consent Process:
Recognizing that informed consent encompasses much more than a form or document there are a number of methods
employed to educate a potential subject as to what is involved in a particular research project. The forms used are one
method for documenting the informed consent process.
1. Is written informed consent required for this project?
 If YES, are the individual consent forms available for review?
2. Is written HIPAA authorization required? http://privacyruleandresearch.nih.gov/clin_research.asp
 If YES, are the individual consent forms available for review?
Yes
No
Yes
No
Yes
No
Yes
No
II. Confidentiality of Research Data:
Confidentiality- the treatment of information that an individual has disclosed in a relationship of trust and with the
expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original
disclosure without permission. This can be addressed via locked files, password protection, coded data.
1. Does data collected for this project include private identifiable information?
Yes
No
Yes
No
Yes
No
Yes
No
45 CFR46.102(f)(2)
 If YES, check all that are in place to protect this information:
a) Paper-based records: secure location with limited personnel access
b) Computer based files: Limited access privileges, passwords and encryption
c) Access and storage procedures described in consent procedure
d)Participant’s names and private identifiable info are stored separately
2. Did any breaches of confidentiality occur during the most recent approval period?
 If YES, was the breach reported to the IRB?
 If a breach occurred and was NOT reported the IRB, please provide an explanation:
3. Is there a process for checking data accuracy after data are entered into an electronic database
or spreadsheet (i.e. a process to check for data entry errors)?
 If YES, please describe the process:
 If NO, please provide an explanation:
III. Unanticipated Problems including Adverse Events:
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
The IRB requires reporting of events that are: (1) unforeseen and (2) indicate that participants or others are at increased
risk of harm. If yes to both, the problem is considered an unanticipated problem involving risks to participants or others.
Each protocol can address unanticipated problems via a safety review or monitoring procedure. There are many valid
methods to address the requirements for an appropriate level of review dependent on the specifics of the protocol.
Social and Behavioral research is less likely to involve an experimental therapy in the biomedical context. However, social
and behavioral research may involve risks of psychological, social, economic, or legal harms or may involve the risk of
breaches of confidentiality.
Please refer to the following website for some examples of unanticipated problems:
www.upenn.edu/regulatoryaffairs/human/AdverseEvents.html
1.
Have there been any unanticipated, study-related problems that posed risk to subjects or
others?
Yes
No
If YES, how were unanticipated problems identified and how were they addressed? Also please provide a brief description
of the reporting mechanism
The remaining three areas are designed to consider the study on a continuum. Much like the continuing review information
provided on an annual basis these areas provide a window into the study progress.
IV. Withdrawal/Accrual Data:
1.
How many participants have withdrawn from the study in the last approval period?
2.
For withdrawn participants, are the reasons for withdrawal recorded?
Yes
No
Yes
No
 IRB communications (e.g. IRB approval letters)
Yes
No
 Protocol (All IRB-approved versions)
Yes
No
 If NO, please provide a brief explanation
3.
For withdrawn participants, do the reasons for withdrawal suggest any issues with the
consent process or monitoring?

If YES, please provide a brief explanation/comment:
V. Protocol Documents
1.
Are records for the following maintained and available?
If NO to either of the above questions, please provide a brief explanation/comment:
VI. Vulnerable Populations:
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
1.
Has your study enrolled pregnant women?
Yes
No
 If YES, was the study initially reviewed under Subpart B? See supplemental forms:
www.upenn.edu/regulatoryaffairs/human/forms.html
Yes
No
Has your study enrolled prisoners?
http://grants2.nih.gov/grants/policy/hs/prisoners.htm#Definitions
Yes
No
 If YES, was the study initially reviewed under Subpart C? See supplemental forms:
www.upenn.edu/regulatoryaffairs/human/forms.html
Yes
No
Has your study enrolled children?
www.hhs.gov/ohrp/children
Yes
No
 If YES, was the study initially reviewed under Subpart D? See supplemental forms:
www.upenn.edu/regulatoryaffairs/human/forms.html
Yes
No
If the study was NOT initially reviewed under Subpart B, but is enrolling pregnant
women, please contact the IRB so we may assist you in addressing the special requirements
concerning this research population: 215-898-2614
2.
If the study was NOT initially reviewed under Subpart C, but is enrolling prisoners or a
participant has become a prisoner while enrolled in the study, please contact the IRB so we
may assist you in addressing the special requirements concerning this research population:
215-898-2614
3.
If the study was NOT initially reviewed under Subpart D, but is enrolling children,
please contact the IRB so we may assist you in addressing the special requirements
concerning this research population: 215-898-2614
Please attach any additional documentation you consider relevant to the self-assessment
By signing this form the principal investigator and the person completing the from (if other than the investigator) certify that
he/she has disclosed to the IRB all relevant information concerning adverse events or other issues that might affect the
risk-to-benefit analysis of this study.
Principal Investigator Name:
Principal Investigator Signature:
Date:
Name of Person Completing the Form (if other than PI):
Signature of Person Completing the Form:
[IRB USE ONLY]
APPROVED VIA EXPEDITED REVIEW:
REFERRED TO CONVENED IRB:
DATE:
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