University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
INSTITUTIONAL REVIEW BOARD
SELF-ASSESSMENT FORM FOR HUMAN RESEARCH
PRINCIPAL INVESTIGATOR:
PROTOCOL TITLE:
PROTOCOL #:
EXPIRATION DATE:
REVIEW BOARD:
SPONSORING AGENCY:
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
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
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?
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006
 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)?
Yes
No
 If YES, please describe the process:
 If NO, please provide an explanation:
III. Unanticipated Problems including Adverse Events:
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
 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?
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University of Pennsylvania  Institutional Review Board
3624 Market Street, Suite 301 South, Philadelphia PA 19104-6006

If YES, please provide a brief explanation/comment:
V. Protocol Documents
1.
Are records for the following maintained and available?
 IRB communications (e.g. IRB approval letters)
Yes
No
 Protocol (All IRB-approved versions)
Yes
No
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 NO to either of the above questions, please provide a brief explanation/comment:
VI. Vulnerable Populations:
1.
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
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