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Appendix 5 1 Unfunded APPENDIX 5

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APPENDIX 5.1
Application Form for
UNFUNDED RESEARCH—CALIFORNIA STATE UNIVERSITY, FRESNO
COMMITTEE ON THE PROTECTION OF HUMAN SUBJECTS
Please type
PRINCIPAL INVESTIGATOR____________________________________________________________________________
Name Dept. (unit) Mail Stop Number
________________________________ _________________________________
Telephone Number Dept. Telephone Number
Student’s name or collaborator(s)__________________________________________________________________________
(if applicable) (if a graduate school thesis, so indicate) (affiliation if collaborative research)
__________________________________ _________________________________
Telephone Number Telephone Number
TITLE__________________________________________________________________________________________________
The Principal Investigator is responsible for fully understanding the Policy and Procedures of the CPHS. Below
indicate your judgment as Principal Investigator as to the RISK category of the present study. (See definitions on the
reverse of this sheet.) (If exempt see 3.52)
Minimal Risk _____
PROCEDURES
1. Attach your protocol and submit to your
department chair for review by your
human subjects committee.
2. Your departmental committee will review
the protocol status and if it agrees with
the determination of “minimal risk”
status (see Appendix 5.3), then
3. Your department chair will keep the
forms for 5 years.
4. Your responsibilities have been satisfied.
HOWEVER,
(If the departmental review changes the
determination to “At Risk,” follow the
procedure to the right of this page.)
At Risk _____
PROCEDURES
1. Attach your protocol and submit to
your department chair for review by
your human subjects committee. (A
sample informed consent must be
included.)
2. Submit the department review
form(s) with this form to the CPHS.
3. Transmit all reviews and ten (10)
copies of the protocol to the CPHS
for review. Send one additional
copy to the Dean.
4. Allow two weeks during the school
year for your response from the
CPHS.
"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 1 Unfunded APPENDIX 5

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Completed 18 February 2020

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