Fillable Reviewer Form For Expedited Reviews (Southern Utah University)

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Reviewer Form For Expedited Reviews (Southern Utah University)

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Southern Utah University Institutional Review Board
REVIEWER CHECKLIST
SUU IRB Documentation for Expedited Reviews 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
Expedited research proposals must meet the requirements below to qualify for expedited review:
There is an intent to publish/present off campus
Participants do not meet the definition for "vulnerable population"
Research involves no more than minimal risk
Are participants part of the SUU Community?
YES NO
The expedited review procedure may not be used where identification of the subjects and/or
their responses would reasonably place them at risk of criminal or civil liability or be damaging to
the subjects: financial standing, employability, insurability, reputation, or be stigmatizing, unless
reasonable and appropriate protections will be implemented so that risks related to invasion of
privacy and breach of confidentiality are no greater than minimal.
Is this condition met?
YES NO
Categories eligible for expedited review (Select YES or NO for each of the following)
1.Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
a.(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is
not required. (Note: Research on marketed drugs that significantly increases the risks or
decreases the acceptability of the risks associated with the use of the product is not eligible for
expedited review.)
b. Research on medical devices for which (i) an investigational device exemption application (21
CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and
the medical device is being used in accordance with its cleared/approved labeling.
YES NO
2.Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a.(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the
amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more
frequently than 2 times per week; or b. from other adults considering the age, weight, and
health of the subjects, the collection procedure, the amount of blood to be collected, and the
frequency with which it will be collected. For these subjects, the amount drawn may not exceed
the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more
frequently than 2 times per week.
YES NO
3.Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of
exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine
patient care indicates a need for extraction; (d) excreta and external secretions (including
sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by
chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta
removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to
or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection
procedure is not more invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells
collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after
saline mist nebulization.
YES NO
4.Collection of data through noninvasive procedures (not involving general anesthesia or
sedation) routinely employed in clinical practice, excluding procedures involving x-rays or
microwaves. Where medical devices are employed, they must be cleared/approved for
marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are
not generally eligible for expedited review, including studies of cleared medical devices for new
indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance
and do not involve input of significant amounts of energy into the subject or an invasion of the
subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d)
electrocardiography, electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow,
and echocardiography; (e) moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the age, weight, and health of the
individual.
YES NO
5.Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for nonresearch purposes (such as medical treatment or
diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations
for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research
that is not exempt.)
YES NO
6.Collection of data from voice, video, digital, or image recordings made for research purposes
YES NO
7.Research on individual or group characteristics or behavior (including, but not limited to,
research on perception, cognition, motivation, identity, language, communication, cultural beliefs
or practices, and social behavior) or research employing survey, interview, oral history, focus
group, program evaluation, human factors evaluation, or quality assurance methodologies.
(NOTE: Some research in this category may be exempt from the HHS regulations for the
protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to
research that is not exempt.)
YES NO
8.Continuing review of research previously approved by the convened IRB as follows:
a. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects
have completed all research-related interventions; and (iii) the research remains active only for
long-term follow-up of subjects; or b. where no subjects have been enrolled and no additional
risks have been identified; or c. where the remaining research activities are limited to data
analysis.
YES NO
9.Continuing review of research, not conducted under an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do not apply but the
IRB has determined and documented at a convened meeting that the research involves no
greater than minimal risk and no additional risks have been identified.
YES NO
The activities listed above should not be deemed to be of minimal risk simply because they are
included on this list. Inclusion on this list merely means that the activity is eligible for review through
the expedited review procedure when the specific circumstances of the proposed research involve
no more than minimal risk to human subjects.
Checklist Items
Method of Subject Selection and Recruitment:
If there are special physiological, psychological, or social characteristics of the target population
which could pose special risks for them, these characteristics have been
identified and individuals possessing them will be excluded from the study?
YES NO NA
Are there incentives to participate which are excessive or coercive?
YES NO NA
Comments, if any, about Method of Subject Selection and Recruitment
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
Does the proposed research 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
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
Comments, if any, about Required Elements of the Informed Consent
Minimal Risks:
There is no/minimal risk of breaching confidentiality
YES NO NA
There is no/minimal risk of evoking emotional distress or other negative emotional response(s)
YES NO NA
There is no/minimal foreseeable risk to subject's reputation and/or social status
YES NO NA
There is no/minimal foreseeable legal risk to subject
YES NO NA
There is no/minimal foreseeable risk to subject's employability or employment status
YES NO NA
If using deception, the deception does not violate participants' rights, is unlikely to affect their
decision of whether to participate, and does not involve more than minimal risk.
YES NO NA
Comments, if any, on Minimal Risks
Benefits
There are immediate benefits to the individual
YES NO NA
There are probable benefits to the target population
YES NO NA
The research will likely contribute to the field of study/organization
YES NO NA
Comments, if any, on Minimal Risks
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 Expedited Reviews (Southern Utah University)

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Completed 26 July 2020

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