1. Institutional Review Board
For Human Participants in Research
Utah Valley University

2. 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.

3. What is a human subject?
Living individuals whom an investigator conducting research obtains
Data through intervention or interaction
Identifiable private information

4. What is research?
"a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." 

5. 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;
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.

6. Belmont Principles Part of Protection of Human Subjects law
Respect for persons – individuals treated as autonomous human beings with right to make own decisions
Beneficence – Do no harm, maximize benefits, minimize risk
Justice – Study designed for equal treatment of subjects

7. Classification of IRB Review
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.
Exempt Review
Expedited Review
Full Board Review

8. What is exempt research?
Exempt research is reviewed only by IRB chair and administrator
Includes research of negligible risk in the following situations:
Educational research in commonly accepted settings with normal practices
Use of educational tests, surveys, interviews, or observations of public behavior
Secondary use of existing data or specimens with no identifiable information
Examining public benefit or service programs
Research involving taste and food quality/consumer acceptance
Not eligible if information recorded is identifiable AND disclosure could place subjects at risk of criminal, civil liability, or harm reputation
Not eligible if research involves prisoners and sometimes children

9. What is an expedited review?
Expedited research is reviewed by chair and one other board member.
Expedited review covers research that involves minimal risk and falls into
Clinical studies of drugs or medical devices
Collection of blood samples
Prospective collection of biological specimens by noninvasive means
Collection of data through noninvasive procedures excluding X-rays
Research using data, documents, records, or specimens collected for non-research purposes
Collection of data from voice, video, digital, or image recordings made for research purposes
Research on characteristics or behaviors (perception, cognition, motivation, cultural beliefs

10. What is a full review?
Research involving moderate to greater risk to the subject requires review by the full IRB.
Full review covers all research not falling into the two prior categories.

11. Students as research subjects
Considered a vulnerable population because might perceive that their grades or faculty favor is dependent on their participation.
Must be informed in writing that participation is voluntary and have right to withdraw without prejudice
If extra credit offered for participation, students must be offered a reasonable alternative to participation that is equal in extra credit value and time/effort
Cannot be exempt if:
There is risk to the students
Identifiable information is recorded

12. 2. How do you prepare?
Before starting the paperwork you should have a planned research project. This includes:
Research purpose/goals/literature review
Methods design/population and sample selection
Measures/instrumentation/data collection procedures
Description of risks and benefits and a plan for minimizing risks to participants (scientifically valid design to justify risks)
Plan to document informed consent and collect/store/analyze data in secure manner
All persons associated with the project must complete CITI online training in “The Protection of Human Subjects in Research” at

13. Informed Consent
Federal regulations state “An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that;
The research involves no more than minimal risk to the subjects;
The waiver of alteration will not adversely affect the rights and welfare of the subjects;
The research could not practicably be carried out without the waiver or alteration;
Whenever appropriate, the subjects will be provided with additional pertinent information after participation
Must at least have an informed consent statement

14. Implied Informed Consent
Must include:
Purpose of research
Rationale (why important and how to be used)
Contact person
Statement about confidentiality
Time it will take to complete
Appreciation for participation
Statement that completing survey serves as consent
IRB Statement "If you have questions regarding your rights as a research participant, or if problems arise which you do not feel you can discuss with the Investigator, please contact the Institutional Review Board Office at (801) "

15. 3. What is the process?
What are the IRB paperwork requirements and processes?
How long does it take?
What if I need help?

16. 3a. What are the IRB paperwork requirements and processes?
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.

17. 3a. What are the IRB paperwork requirements and processes?
Complete IRB application on Axiom Mentor
Complete all required sections
Include Application Protocol Description Form

18. 3b. 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 on Axiom Mentor, the entire process (if the packet needs no revisions) should take approximately (you can see where it is in the process when you log into your account and select the application:
Remember: You CANNOT start your research until you have IRB approval
Exempt (1-2 weeks)
Expedited (2-3 weeks)
Full Review (4-6 weeks)

19. 3c. What if I need HELP? Department Chair Your School’s IRB Member(s)
Colleagues who have successfully gone through the process
Websites (
Cyrill Slezak PhD, Michaela Gazdik Stofer PhD, or Shelly Andrus

20. IRB School Representatives
Education: Mi Ok Kang, Vessela Ilieva
Emergency Services: Rodger Broome, Matt Flint
History & Political Science: Steven Sylvester
Humanities: Lars Eggertsen
Science: Michaela Gazdik Stofer, Sara Flood
Exercise Science: Ellis Jensen, Robert Sawyer
Student Leadership: Benjamin Johnson, Doug Gardner
Unaffiliated: Greg Craner

21. Utah Valley University
QUESTIONS?
For further information see the
Institutional Review Board website at or
Utah Valley University