UUV
Institutional Review Board
For Human Participants in Research
Utah Valley University
A Cooperative Effort by the
University Compliance Office
& Office of Engaged Learning
Andrew Creer, Ph.D. – IRB Chair
Nancy L. Bartlett – IRB Administrator
Why know about the IRB?
• UVU encourages scholarship and research.
• The University strongly encourages research,
presentations, and publications from all
faculty members.
• Many kinds of research will involve human
subjects.
• Any research data collected from human
subjects needs to be reviewed through the
IRB process.
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IRB Training Outline
1. What is the IRB and its mission?
2. Why do we need an IRB?
3. How hard is the process?
4. How do we prepare?
5. How do we do it?
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1. What is the IRB?
The IRB is the entity with the jurisdiction
for reviewing and approving all research
involving human subjects carried out by
the faculty, staff, or students of UVU.
IRB paperwork must be submitted
before research can be approved. IRB
approval must be obtained before the
data collection can begin.
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What is the IRB’s Mission?
The IRB furthers the University’s research mission
by:
• Reviewing proposed research involving human
participants in order to protect them against
potential risks of research participation while
promoting high-quality studies;
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•
Educating the larger university community about
ethical issues in human participants research;
•
Overseeing compliance with federal, state, and
university regulatory requirements for human
participant research.
2. Why do we need an IRB?
 Adherence to IRB guidelines helps to assure the
highest quality research at UVU.
 The IRB process ensures that UVU-associated
research does not harm participants in any way.
 Federal laws mandate that institutions of higher
education that are participating in any type of
government-sponsored research have an IRB.
 All universities and nearly all colleges have IRBs.
 To publish in reputable journals, faculty often
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must demonstrate that the research has gone
through an IRB process.
3. How hard is the process?
Piece o’ Cake!
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4. How do we prepare?
Before IRB paperwork is started, the researcher(s)
should have planned the research study and
outlined specific research methods. This may
include (but is not limited to) the development of
the following:
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problem statement
research purpose
research questions or hypotheses
literature review
research design
population and sample selection
measures and/or instrumentation
data collection procedures
data analysis procedures
plans for minimizing risks to participants
5. How do we do it? (more questions!)
a. Who needs to submit the
packet?
b. What are the IRB paperwork
requirements and processes?
c. How long does it take?
d. What are the three levels of
review?
e. What if I need help?
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5a. Who submits the packet?
It is the responsibility of the principal
investigator (PI) to submit proposed
research for approval. Approval by the
IRB does not relieve the PI from the
obligation to follow procedures and
rules of the University and any other
regulatory body involved with the
research. For student research, the
advisor or faculty member must be
either the PI or the Co-PI.
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5b. What are the IRB paperwork
requirements and processes?
Refer to the following handouts:
 IRB Process – At a Glance
 Form A – Record of IRB Submission
 Form B – Application for Approval for the
Use of Human Subjects in Research
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IRB Packet Review
 Form A – Record of IRB Submission
 Form B – Application for Approval for the
Use of Human Subjects in Research
 Blank Instrument
 Informed Consent Letter or Form
 Permission Letters (if applicable)
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5c. How long does it take?
The IRB is committed to move packets through the
process as quickly as possible. Once the completed
packet is submitted to the IRB, the entire process (if the
packet needs no revisions) should take approximately:
 Exempt (1-2 weeks)
 Expedited (2-3 weeks)
 Full Review (4-6 weeks)
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Determination of Review Level
First, the IRB Chair, in conjunction with the IRB,
determines the level for review.
The UVU Investigator’s Handbook for Human
Participants includes a detailed description and
list of examples. Even with this document you
may have questions because there are so many
possible types of research.
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5d. What are the review levels?
Exempt Review
Expedited Review
Full Board Review
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What is exempt research?
The exempt categories are determined by the
federal regulatory agencies and include research
of minimal risk in the following situations:
 The study of some educational practices
 Survey interview of adult subjects or public
figures (non-sensitive topic areas only)
 Observation of non-institutionalized adults
and minors under some circumstances
 Demonstration or service projects under the
“Social Security Act”
University of Minnesota
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What is exempt research? (cont.)
Other examples include:
• Research conducted in established or commonly accepted
educational settings.
• Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement) survey procedures,
interview procedures, or observation of public behavior, as
long as anonymity of respondents and confidentiality of
answers which could result in risk is maintained.
• Research involving the collection or study of existing data,
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documents, records…, if these sources are publicly
available or if the information is recorded by the investigator
in such a manner that subjects cannot be identified, directly
or through identifiers linked to the subjects.
What is an expedited review?
Expedited review categories are designated by
federal regulatory agencies. Expedited review
covers research that involves only minimal risk
procedures such as those requiring the drawing of
small amounts of blood, removal of dental plague,
moderate exercise by normal volunteers, the study
of individual or group behavior where the behavior
is not manipulated and the subjects are not
exposed to any stressful situation.
University of Minnesota
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What is an expedited review?
 Research involving materials that have been collected or will be
collected solely for non-research purposes (such as medical
treatment or diagnosis).
 Collection of data from voice, video, digital, or image recordings
made for research purposes.
 Research on individual or group 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.
(See Handbook for more)
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What is a full review?
Research involving more than
minimal risk to the subject
requires review by the full IRB.
Full review covers all research
not falling into the two prior
categories.
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5e. What if I need HELP?
 Department Chair
 Your School’s IRB Member(s)
 Colleagues who have successfully gone
through the process
 Websites (www.uvu.edu/irb)
 Andrew Creer, Ph.D. or Nancy L. Bartlett
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IRB School Representatives
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Education: Mi Ok Kang
Emergency Services: Rodger Broome
University College: Chitra Duttagupta
Humanities: David Connelly, Lars Eggertsen
Science & Health: Andrew Creer
Unaffiliated: Cameo Johnson, Greg Craner
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QUESTIONS?
For further information see the
Institutional Review Board website at
www.uvu.edu/irb or email irb@uvu.edu
Utah Valley University