Fillable Reviewer Form For Fullboard Review (Southern Utah University)

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Reviewer Form For Fullboard Review (Southern Utah University)

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Southern Utah University Institutional Review Board
REVIEWER CHECKLIST
SUU IRB Documentation for Full Board Status
This form should be downloaded and opened with Adobe Reader or Adobe
Acrobat.
Reviewer Reviewer's College Date
Reviewer's E-mail Reviewer's Phone Extension
Title of Proposed Research
Principle Investigator (PI) PI's E-mail
PI's College
Research proposals which meet one or both of the criteria below must receive a full board
review:
Participants are considered vulnerable
The research involves more than minimal risk
Please answer each of the following questions, and for any No responses, provide
comments below, in the comment section.
Risks and anticipated benefits are accurately identified, evaluated, and described by the
principle investigator?
YES NO N/A
Have special vulnerabilities among prospective subjects that might be relevant to evaluating the
risk of participation been considered by the principle investigator?
YES NO N/A
If the research involves the evaluation of a therapeutic procedure, has the risks and benefits of
the research interventions been evaluated separately from those of the therapeutic
interventions?
YES NO N/A
Has every effort has been made to minimize risks and maximize the likelihood of benefits to
participants?
YES NO N/A
Have adequate provisions have been made for a continuing reassessment of the balance
between risks and benefits?
YES NO N/A
Are the risks are NOT so strong that they would warrant the use of a data and safety monitoring
committee?
YES NO N/A
Comments
Informed Consent
Will Investigators obtain signed consent in every case where it is required?
YES NO N/A
Will Investigators obtain proof of ascent in every case where it is required?
YES NO N/A
All conditions are in keeping with standards for voluntary and informed consent?
YES NO N/A
Comments
Categories eligible for expedited review (Select YES or NO for each of the following)
Checklist Items
Required Elements for Informed Consent
Participants have been informed about the investigator's name and position at SUU
YES NO NA
Participants have been informed about the purposes of the research
YES NO NA
Participants have been informed about the expected duration of the subject's participation
YES NO NA
Participants have been informed about the procedures to be followed in the research
YES NO NA
Participants have been informed about the type/nature of the questions, if using surveying/
interviewing methods
YES NO NA
Participants have been informed that participation is voluntary. and that they may discontinue
the study at any time for any reason without penalty, and that they may ask questions at any
time.
YES NO NA
Participants have been informed that they may skip any question they do not wish to answer, if a
survey/interviewing method is being used.
YES NO NA
Participants have been informed about any reasonable, foreseeable risks or discomforts.
YES NO NA
Participants have been informed about any benefits to the participant which may reasonably be
expected from the research
YES NO NA
Participants have been informed about whether participation and the data collected is
anonymous or confidential
YES NO NA
Participants have been informed about who to contact for information or concerns regarding the
study
YES NO NA
Participants have been informed about whether or not compensation will be awarded and the
details thereof.
YES NO NA
Participants have been informed that study involves research.
YES NO NA
Participants have been informed about any procedures which are experimental.
YES NO NA
Participants have been informed about alternative procedures or courses of treatment, that
might be advantageous to the subject.
YES NO NA
Participants have been informed about who will have access to individual participant's data.
YES NO NA
Participants have been informed about when, how, and who to contact to obtain the results of
the study.
YES NO NA
Participants have been informed about how to contact the SUU IRB.
YES NO NA
Comments, if any, about Required Elements of the Informed Consent
Other Considerations
The proposed explanations of the research provide an accurate assessment of its risks and
anticipated benefits.
YES NO NA
The possibility (or improbability) of direct benefit to the subjects is fairly and clearly described.
YES NO NA
The language and presentation of the information to be conveyed is appropriate to the subject
population (including a translation into a language other than English if applicable).
YES NO NA
The timing of and setting for the explanation of the research is conducive to good decision
making.
YES NO NA
Nothing more can be done to enhance the prospective subjects' comprehension of the
information and their ability to make a choice.
YES NO NA
The individuals who will be explaining the research to potential subjects are identified.
YES NO NA
The individuals who will be explaining the research to potential subjects are qualified
YES NO NA
Someone in addition to or other than the investigator should and will be present.
YES NO NA
Subjects will be reeducated and their consent acquired periodically.
YES NO NA
The IRB need NOT monitor incoming data to determine whether new information should be
conveyed to participating subjects.
YES NO NA
Someone in addition to or other than the investigator should and will be present.
YES NO NA
A waiver of some or all of the consent requirements is requested and the importance of the
research justifies such a waiver
YES NO NA
The research design cannot be modified to eliminate the need for deception or incomplete
disclosure.
YES NO NA
Subjects will be given more information after completing their participation
YES NO NA
The nature of the disease or behavioral issue to be studied permits free consent
YES NO NA
Incentives offered for participation are unlikely to unduly influence a prospective subject's
decision to participate.
YES NO NA
There are adequate procedures for monitoring the consent process.
YES NO NA
Arrangements need NOT be made for the IRB or its representative observe the consent
process.
YES NO NA
Comments, if any.
Selection of Subjects
The burdens of participating in the research will fall on those most likely to benefit from the
research.
YES NO NA
The solicitation of subjects avoids placing a disproportionate share of the burdens of research
on any single group.
YES NO NA
The nature of the research requires or justifies using the proposed subject population.
YES NO NA
If there are groups of people who might be more susceptible to the risks presented by the study
(and who therefore ought to be excluded from the research) the procedures for identifying such
individuals are adequate.
YES NO NA
To the extent that benefits to the subjects are anticipated, they are distributed fairly.
YES NO NA
There are no other groups of potential subjects with a greater need to receive any of the
anticipated benefits.
YES NO NA
To the extent that participation in the study is burdensome, these burdens are distributed fairly.
YES NO NA
The proposed subject population is not already so burdened that it would be unfair to ask them
to accept an extra burden.
YES NO NA
All special physiological, psychological, or social characteristics of the subject group which pose
special risks for them have been identified.
YES NO NA
It is NOT possible to conduct the study with other, less vulnerable subjects.
YES NO NA
The selection process does not overprotect potential subjects who are considered vulnerable
(e.g., children, cognitively impaired, economically or educationally disadvantaged persons,
students of researchers, seriously ill persons) so that they are denied opportunities to participate
in research.
YES NO NA
The subjects are susceptible to pressures, and every effort has been made to reduce the
pressures or minimize their impact.
YES NO NA
Special safeguards are included to protect the rights and welfare of subjects who are likely to be
vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, persons
with physical or mental illness, and persons who are economically or educationally
disadvantaged).
YES NO NA
Comments
Privacy & Confidentiality
If one or more participant's identity is known to investigator(s), adequate measures have
been taken to protect their identity.
YES NO NA
The research does NOT involve observation or intrusion in situations where the subjects have a
reasonable expectation of privacy.
YES NO NA
Are the investigator's disclosures to subjects about anonymity/confidentiality adequate?
YES NO NA
The investigators do NOT want to review existing records to select subjects for further study.
YES NO NA
The investigator(s) will NOT be collecting sensitive information about individuals.
YES NO NA
Documentation of consent should NOT be waived in order to protect confidentiality.
YES NO NA
Comments, if any, about Privacy & Confidentially
Method for Obtaining Informed Consent:
Is informed consent information to be presented in a manner which is clear to participants?
YES NO NA
Is there exculpatory language which appears to waive participants’ rights or release
SUU from negligence?
YES NO NA
Comments, if any, about Method for Obtaining Informed Consent:
Required Elements for Informed Consent
Participants have been informed about the investigator's name and position at SUU
YES NO NA
Participants have been informed about the purposes of the research
YES NO NA
Participants have been informed about the expected duration of the subject's participation
YES NO NA
Participants have been informed about the procedures to be followed in the research
YES NO NA
Participants have been informed about the type/nature of the questions, if using surveying/
interviewing methods
YES NO NA
Participants have been informed that participation is voluntary. and that they may discontinue
the study at any time for any reason without penalty, and that they may ask questions at any
time.
YES NO NA
Participants have been informed that they may skip any question they do not wish to answer, if a
survey/interviewing method is being used.
YES NO NA
Participants have been informed about any reasonable, foreseeable risks or discomforts.
YES NO NA
Participants have been informed about any benefits to the participant which may reasonably be
expected from the research
YES NO NA
Participants have been informed about whether participation and the data collected is
anonymous or confidential
YES NO NA
Participants have been informed about who to contact for information or concerns regarding the
study
YES NO NA
Participants have been informed about whether or not compensation will be awarded and the
details thereof.
YES NO NA
Are the incentives offered are reasonable, based upon the complexities and inconveniences of
the study and the particular subject population?
YES NO NA
It is NOT necessary for the IRB to monitor subject recruitment to determine whether coercion or
undue influence is a problem.
YES NO NA
Comments, if any, about Required Elements of the Informed Consent
Decision:
Based on the above materials this proposal should be:
Accepted as submitted
Accept contingent on minor revisions
Not be accepted
If minor revision are needed list below
If the proposal should not be accepted, provide the justification for this decision
Submit
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Reviewer Form For Fullboard Review (Southern Utah University)

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Completed 26 July 2020

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