All research involving human subjects carried out by faculty, staff, or students of Utah Valley University is under the review and approval jurisdiction of the University’s Institutional Review Board (IRB). Specific IRB paperwork must be submitted to the IRB office before research can be approved, and approval must be obtained before the actual research (data collection) can begin.
Before IRB paperwork is started, the researcher(s) should complete preparatory research stages and outline specific plans and methodologies. This includes (but isn’t limited to) the development of the following: a problem statement, research purpose, research questions or hypotheses, literature review, research design, population and sample selection, measures/ instrumentation, data collection procedures, and analysis procedures.
After the researcher, and their faculty mentor if a student, have developed the research plan, including having identified the risks and benefits of conducting the research, determined who will be the subjects of the research, including the methods of subject recruitment, and have clearly defined the specific research methodologies to be applied, they should proceed to:
1. Training. Complete the required CITI online training in “The Protection of Human Subjects in Research” available on the UVU website at www.uvu.edu/irb .
2. Applications. Complete the IRB online application form (handwritten submissions are strongly discouraged).
3. Instrument. Attach a blank copy of the final version of the research instrument you are using to gather data.
4. Informed Consent. Attach a copy of the participant informed consent form or letter you intend to use (this is used to obtain the subject’s permission to willingly participate in your research).
5. Organization’s Permission. If you are doing your research in specific organizations, you must attach an email or letter from the primary contact in each organization specifying the organization agrees to participate. For example, if you are using a random sample of 100 Utah State Department of Health employees and 100 Wal-Mart employees, you need to attach a letter from a decision-maker in each organization confirming agreement to participate in the study and also of specific acknowledgment of what is expected of the organization and prospective participants (see UVU Investigator’s Handbook for further details).
6. Complete Packet. Obtain the appropriate signatures. Next, send the application form, the research instrument, and the letter of informed consent to the IRB office. If the research is approved as exempt, the Chair of the IRB will sign the application and send an authorization e-mail to the PI. If the research is categorized as expedited, then two to three members of the IRB will review the proposal. If approved, then the Chair of the IRB will sign the application and send an authorization e-mail to the PI. If the research requires full board review, then the full IRB will review the proposal at the next monthly meeting of the Board. If approved, the Chair of the IRB will sign the application form and send an authorization e-mail to the PI.
7. Requested Revisions. After a packet is submitted, revisions may be requested. If small changes are requested, it is expected that researchers resubmit only the information in question. If minor changes are requested by the IRB for expedited and full board review projects, the Chair of the IRB can give his/her approval to proceed to data collection without taking the project before the full IRB for a second time.
8. Data Collection. Once the Chair of the IRB has approved your proposal, then you can start your research and begin to collect data!
NOTE: For student research, the principal investigator (PI) must be supervised by a faculty or staff advisor. If the PI is not a UVU employee or student, then the PI must obtain the approval of the UVU department chair or director of the discipline over the proposed research.
Categories of Research
The IRB Chair, in conjunction with the full Board, make the final determination of review category. Here are general definitions for the 3 levels of research review (see §II of the UVU IRB Investigator’s Handbook for more details).
Non-IRB Regulated Research —Includes research not involving human subjects, and research not giving rise to any additional interactions with humans due to research (for example, observing people in a public place without interacting with them).
Exempt Review —Category is determined by the federal regulatory agencies and includes research of negligible risks in the following situations:
• The study of some educational practices
• Surveys of adult subjects or public figures (non-sensitive topic areas, only)
• Observation of non-institutionalized adults, and minors under some specific circumstances
• Archival or secondary use of data or specimens with no identifiable info
• Demonstration or service projects under the “Social Security Act”
Expedited Review —Expedited review covers research that involves only minimal risk procedures such as those involving the drawing of small amounts of blood, removal of dental plaque, 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. Expedited review categories are designated by federal regulatory agencies.
Full Board Review —Research involving moderate or greater risk to subjects requires review by the full board. Full review covers all research not falling into the categories of exempt or expedited review.
**For more information about the IRB process at UVU see the " About UVU IRB " PowerPoint.
IRB Contact Information: Email: firstname.lastname@example.org; Office: BA 203; Phone: 863-8156; Utah Valley University, Office of the IRB, 800 West University Parkway, mailcode 272, Orem UT 84058