Fillable Appendix 5 3 Unit Review Form APPENDIX 5

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Appendix 5 3 Unit Review Form APPENDIX 5

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APPENDIX 5.3
COMMITTEE ON THE PROTECTION OF HUMAN SUBJECTS
DEPARTMENTAL (UNIT) REVIEW FORM
CALIFORNIA STATE UNIVERSITY, FRESNO
Please type
PRINCIPAL INVESTIGATOR________________________________________________________________________________
Name Dept. (unit) Mail Stop Number
________________________________ _________________________________
Telephone Number Dept. Telephone Number
If student or collaborative research:_____________________________________________________________________________
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
Name ______________________________________________________________
At risk _________________________ Minimal risk _________________________
COMMENTS:
Place your signature in the category
of your judgment
APPROVED
_________________________
DISAPPROVED
_________________________
REVIEWER 2
Name ______________________________________________________________
At risk _________________________ Minimal risk _________________________
COMMENTS:
Place your signature in the category
of your judgment
APPROVED
_________________________
DISAPPROVED
_________________________
REVIEWER 3
Name ______________________________________________________________
At risk _________________________ Minimal risk _________________________
COMMENTS:
Place your signature in the category
of your judgment
APPROVED
_________________________
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 this form(s) for 5
years. If funding is sought for this study or it is “at risk,” ten (10) copies of the protocol and this form are forwarded to the university
CPHS, Thomas Administration, Room 121, M/S TA52, with one additional copy to the dean’s office. (See sections 3.7 or 3.8.)
"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 SUBJECT'S FINANCIAL OR
EMPLOYMENT STATUS; OR ABROGATION OF ANY CIVIL RIGHT.
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Appendix 5 3 Unit Review Form APPENDIX 5

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Completed 18 February 2020

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