PROTOCOL REVIEW FORM [rev May 2013]
Institutional Review Board for Human Subjects Research
California State University, Bakersfield
Protocol #:_____________
Requested Return Date:
Investigator: __________________________
____________________
Project Title: _____________________________________
Are the qualifications of the investigator(s) appropriate for the proposed research?
_____ YES _____ NO
Comments:
Is the purpose clear in terms of what the research could add to existing knowledge?
_____ YES _____ NO
Comments:
Are the methods and procedures clear and appropriate to achieve the stated purpose of the
research?
_____ YES _____ NO
Comments:
Are the procedures for Information Security clear and adequate for data collection?
_____ YES _____ NO
Comments:
Are the procedures for Information Security clear and adequate for data handling?
_____ YES _____ NO
Comments:
Are the procedures for Information Security clear and adequate for data storage?
_____ YES _____ NO
Comments:
Are the procedures for Information Security clear and adequate for data reporting?
_____ YES _____ NO
Comments:
Are the procedures for Information Security clear and adequate for data destruction?
_____ YES _____ NO
Comments:
Are the criteria for subject selection and subject rejection equitable in terms of the purpose of the
proposed research?
_____ YES _____ NO
Comments:
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Are the research subjects from any of the following vulnerable populations?
a.
c.
e.
g.
i.
Children and minors (under 18 years of age)
Institutionalized or hospitalized persons
Mentally-disabled or cognitively-impaired persons
Economically- or educationally-disadvantaged persons
Ethnic/racial minority persons
b.
d.
f.
h.
j.
Incarcerated persons
Pregnant women
Elderly/aged persons
Students in the classroom
Employees in their workplace
If “yes” for any of the above vulnerable populations, then:
Is there sufficient justification for the use of subjects from vulnerable populations in terms of
the purpose of the proposed research? _____ YES _____ NO
Comments:
Are there additional safeguards clearly specified to protect the rights and welfare of subjects
from vulnerable populations?
_____ YES _____ NO
Comments:
Does the research protocol clearly describe the provisions for managing any adverse reactions,
physical or emotional, as a result of the subject’s participation in the research?
_____ YES _____ NO
Comments:
What potential RISKS do the proposed research place on the subject(s)?
KEY: MIN = Minimal
MOD = Moderate SEV = Severe
_____ a. Physical risk (injury, illness, physically invasive procedure)
_____ b. Risk of criminal or civil liability if responses are disclosed
_____ c. Risk to financial standing or employment status if responses are disclosed
_____ d. Risk to family or personal reputation if responses are disclosed
_____ e. Psychological or emotional risk (anxiety, frustration, stress)
_____ f. Other risks?
Comments:
What types of BENEFITS are likely from the proposed research?
KEY: DIR = Direct
IND = Indirect
L/N = Little or None
_____ a. To the research subject him/herself
_____ b. To the subject population as a generalized group (social class, ethnic/racial group, age
cohort, illness classification, etc.)
_____ c. To the scientific knowledge-base within the discipline
_____ d. To society or humankind in general
_____ e. Other benefits?
Comments:
2
RISKS
Minimal
Moderate
Substantial
RISK/BENEFIT ANALYSIS:
BENEFITS
Minimal
Moderate
Substantial
Select the statement that best summarizes your assessment:
a. RISKS are outweighed by the potential BENEFITS
b. RISKS are not justified relative to the potential BENEFITS
c. RISKS are too severe regardless of the potential BENEFITS
Comments:
Will there be signed written consent [standard procedure]?
Are the following elements of informed consent present?
KEY:
Y = Yes
? = Not Clear
_____ a.
N = No
Yes
No
N/A = Not Applicable
Language being used is understandable to the prospective subjects.
Comments:
_____ b. Clear explanation of the purpose of the research.
Comments:
_____ c. Clear indication of the expected duration of the subject’s participation in the research.
Comments:
_____ d. Clear description of the procedures to be followed during the subject’s participation.
Comments:
_____ e. Clear description of any reasonable foreseeable risks or discomforts to the subject.
Comments:
_____ f. Clear description of any reasonable benefits to the subject or to others expected from the research.
Comments:
_____ g. Clear statement of any appropriate alternative procedures or treatments that might be
advantageous to subjects.
Comments:
_____ h. Clear description of the manner in which the confidentiality of records identifying the subject will be
maintained, including the person(s) having access to the data and the use of the data.
Comments:
_____ i. If appropriate, clear explanation of the availability of compensation or medical treatment if injury
should occur.
Comments:
_____ j. There are clear statements that the subject’s participation is voluntary and that refusal to
participate will involve no penalties or loss of benefits to which the subject is otherwise entitled.
Comments:
_____ k. There are clear statements that the subject may discontinue participation in the research
at any time without penalties or loss of benefits to which the subject is otherwise entitled.
Comments:
_____ l. There is a clear statement that a copy of the signed written consent document will be offered to
the person signing the form.
Comments:
Information regarding whom to contact with questions about:
_____ m. The research activity.
Comments:
_____ n. The research subject’s rights.
Comments:
_____o. Any research-related injuries or emotional traumas.
Comments:
3
Is there a request for a waiver of informed consent?
If consent waiver is requested:
KEY:
_____ a.
_____ b.
_____ c.
_____ d.
Y = Yes
? = Not Clear
Yes
No
N = No
The proposed research involves only minimal risk to human subjects.
The alteration or waiver does not adversely affect the rights and welfare of the human subjects.
The proposed research cannot be practicably carried out without the waiver of consent.
The subjects will be given additional pertinent information after their participation in the research.
Comments:
Is there a request for oral or online consent?
If oral or online consent is requested:
KEY:
Y = Yes
? = Not Clear
Yes
No
N = No
a. The proposed research involves only minimal risk to human subjects.
b. There is a written summary of what is to be specifically said to the subject embodying the
elements of informed consent and a record keeping process to indicate that each subject has
consented.
c. The proposed research cannot be practicably carried out without the waiver of written consent.
d. The only record linking the subject and the research would be the consent document itself,
and the principal risk would be potential harm resulting from a breach of confidentiality.
e. Subjects will be provided with a copy of a written document containing the elements of
informed consent.
Comments:
Recommended Action:
____ Full Approval (For Expedited Review or Standard Review)
Conditional Approval (For Standard Review only: conditions established must be satisfied)
Revise and Re-Submit (For Standard Review)
Revisions/Clarifications requested (For Expedited Review)
____ Refer for Standard Review (For Expedited Review)
____ Disapproval (For Expedited Review or Standard Review)
Comments:
_________
Reviewer Signature
_______________
Date
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