Fillable Dept Review Form 2018 DEPARTMENTAL (UNIT) REVIEW FORM

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Dept Review Form 2018 DEPARTMENTAL (UNIT) REVIEW FORM

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Updated 4/12/18 mk
DEPARTMENTAL (UNIT) REVIEW FORM
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS
CALIFORNIA STATE UNIVERSITY, FRESNO
Please type
PRINCIPAL INVESTIGATOR
Name
Department
Mail Stop
If student or collaborative research
Telephone Number
Dept. Telephone Number
Name
Affiliation
Telephone Number
Telephone Number
TITLE OF STUDY
If funding is sought, from what agency?
How did the Principal Investigator designate the research? Minimal risk At risk
REVIEWER 1
Place your signature in the category
of your judgment
Name
At risk Minimal Risk
APPROVED
COMMENTS:
DISAPPROVED
REVIEWER 2
Place your signature in the category
of your judgment
Name
At risk Minimal Risk
APPROVED
COMMENTS:
DISAPPROVED
REVIEWER 3
Place your signature in the category
of your judgment
Name
At risk Minimal Risk
APPROVED
COMMENTS:
DISAPPROVED
The department may wish to route this form to the 3 reviewers or send each reviewer a form. If the review is done on three separate forms,
the Chair ought to give each reviewer the comments of the other reviewers as well as the Principal Investigator. If all three reviewers judge
the proposal as “minimal risk,” the Department Chair notifies the Principal Investigator and keeps the form(s) for 5 years. If funding is
sought for this study or it is “at risk,” one (1) copy (electronic or paper) of the protocol and this form are forwarded to the university CPHS,
Thomas Building, Rm 130, M/S TA51; marykelly@csufresno.edu, with one additional copy to the dean’s office. (See sections 3.7 or 3.8.)
Updated 4/12/18 mk
“Exempt” Research.
If “exempt”, see Section 3.5.2.
“Minimal Risk” Research.
Research IN WHICH THE RISKS OF HARM ANTICIPATED ARE NOT GREATER, PROBABILITY AND MAGNITUDE,
THAN THOSE ORDINARILY ENCOUNTERED IN DAILY LIFE OR DURING THE PERFORMANCE OF ROUTINE
PHYSICAL OR PSYCHOLOGICAL EXAMINATIONS OR TESTS. No research involving any item listed as being “at risk” can
be determined to be minimal risk. A department or other unit review committee may determine that a research proposal submitted,
in the judgment of the principal investigator as “minimal risk”, is actually “AT RISK”.
“At Risk” Research.
“A subject is considered to be ‘at risk’ if he/she is exposed to the possibility of harm- physical, psychological, sociological, or other
as a consequence of any activity that goes beyond the application of those established and accepted methods necessary to meet
his/her needs. The determination of when an individual is ‘at risk’ requires application of sound professional judgment of the
activity in question and the ethical principles contained herein. Responsibility for this determination resides at all levels of
institutional and departmental review.”
(The Institutional Guide to DHEW Policy on Protection of Human Subjects, Washington, D.C., 1971, p.2.)
An illustrative, but not inclusive, list of “at risk” procedures would include experiments involving any aspect, degree, quality, or
amount of any of the following:
Deception, mental stress, including subjection to public embarrassment, humiliation, discomfort, irritation, or harassment, hypnosis,
sensory deprivation, sleep deprivation, normally ingested or inhaled materials in excess or less than normal amounts, injection,
ingestion or inhalation of toxic materials, including all drugs, alcohol or placebos; strenuous physical exertion; use of physical
stimuli in abnormal amounts (e.g., noise, vibration, shock, heat, magnetic fields, radiation); violation of anonymity or
confidentiality of subjects and data; OBSERVATIONS RECORDED ABOUT THE INDIVIDUAL WHICH, IF THEY BECAME
KNOWN OUTSIDE THE RESEARCH, COULD MAKE THE SUBJECT LIABLE TO CRIMINAL OR CIVIL ACTION OR
DAMAGE THE SUBJECTS FINANCIAL OR EMPLOYMENT STATUS; OR ABROGATION OF ANY CIVIL RIGHT.
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Dept Review Form 2018 DEPARTMENTAL (UNIT) REVIEW FORM

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Completed 18 February 2020

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