LOCK HAVEN
UNIVERSITY OF PENNSYLVANIA
Institutional Review Board for
the Protection of Human Subjects
Application
Cover Sheet
To: ___________________________,
Unit Representative or IRB-PHS Chair
Date:__________________________
From: Primary Investigator(s)
____________________ Phone__________
Campus/local address___________________________________________
Co-Investigators/Faculty
sponsor or supervisor_______________________
Project Title________________________________________________
__________________________________________________________
Requested duration of project
approval: ___one year or ___ other:_________
Category of review being requested:
___ Expedited Review or ___ Full Review
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For office use
only: Proposal
Code #_________________ UNIT REPRESENTATIVE APPROVAL/ROUTING Date
received by Unit Representative:
______/______/______ Indicate below to which type of review
this research project conforms. For expedited review research, you must also
indicate the specific exempt category of research. Please follow directions below for routing of this form. |
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EXPEDITED Review Status APPROVED:________________________________ Exempt
research category number qualifying for Expedited Review Status: _________ ** Permit researcher(s) to begin data
collection, forward one copy of this completed form and the proposal
narrative to IRB-PHS Chairperson for filing and auditing purposes. |
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Full RevieW _____________________________________ ** Inform researcher(s) that the study must be
approved by the full IRB-PHS at a regularly convened meeting prior to data
collection. Forward seven copies of this completed form and the proposal narrative
to the IRB-PHS Chairperson for action. |
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Does the project
involve minors (age < 18 years), pregnant women, fetuses, prisoners, or
persons with disabilities? |
___Yes ___No |
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Does this
project involve giving false or misleading information or withholding
information to subjects that might influence their willingness to
participate? |
___Yes ___No |
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Will the procedures
cause any degree of mental discomfort, harassment, invasion of privacy, risk
of physical injury, or threat to the dignity of subjects, or be otherwise
potentially harmful to subjects? |
___Yes ___No |
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Will disclosure
of the human subjects’ responses outside the research setting reasonably
place the subjects at risk or criminal or civil liability or be damaging to
the subject’s financial standing, employability, or reputation? |
___Yes ___No |
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Does the project
deal with sensitive aspects of the subject’s own behavior such as illegal
conduct, drug use, sexual behavior, or use of alcohol? |
___Yes ___No |
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Will
observations be recorded in such a manner that the human subjects can be
identified, directly or through identifiers linked to the subjects? |
___Yes ___No |
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Will subjects’
sign an informed consent that follows the IRB-PHS recommended format? |
___Yes ___No |
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If applicable,
have the following documents been submitted with the application? |
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• Consent
document |
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• Instrument(s)
(e.g., surveys, interview outlines, etc.) |
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• Debriefing
statement |
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• Letter of
agreement from cooperating institution(s) |
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• Letter(s) from
cooperating individuals (e.g., physicians) |
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• Procedures for
emergency medical care |
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Attach the narrative portion of the
application to this form.
The project described in
the attached information was planned to adhere to Lock Haven University IRB-PHS
policies and procedures regarding the use of human subjects. Any additions to
or changes in procedures involving human subjects that occur after review of
the application will be brought to the attention of the IRB-PHS by the
principal investigator. In addition, the IRB-PHS must be notified of any
unanticipated events that do or could affect the safety and well being of
subjects.
Investigator(s)
signature(s):_________________________________________ Date______________________
Co-Investigator/Sponsor
Signature:______________________________________________ Date______________________