- Do I need to apply for Institutional Review Board (IRB) approval?
Yes, if you are a member of the UNLV community (faculty, staff, or student) conducting research involving human subjects or data acquired from human subjects. Students must have their faculty advisors serve as the principal investigators (PI).
- Who is considered a “human subject”?
A “human subject” is defined as a living person about or from whom a researcher obtains 1) data through intervention or interaction with the person; or 2) identifiable private information about the person. For additional information defining intervention and interaction, please see the U.S. Code of Federal Regulations.
- What is considered “research”?
“Research” is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- How do I submit my protocol package?
- Why must human subjects protocols be submitted?
“Federalwide Assurance” to comply with the federal regulations codified as 45 CFR 46. This Federalwide Assurance requires all human subjects research conducted by UNLV researchers to undergo review by an Institutional Review Board (IRB).
- What should I include in my protocol package?
Although some additional information may be required, protocols should include the following:
- The Protocol Proposal Form or Exempt Research Application Form, both of which are available on the CyberIRB website. All applicable sections must be completed. Students must have their faculty advisor listed as the principal investigator (PI).
- The Informed Consent Form should include all the basic elements of informed consent, which is information that must be communicated to research subjects before they participate. The Informed Consent Sample Form will provide additional guidance on completing the Informed Consent Form.
- A copy of the instrument(s) used in the project, such as the survey/questionnaire, interview questions, or data collection sheets.
- Copies of all recruitment materials, such as flyers, brochures, emails, or subject pool descriptions used to recruit subjects.
In addition, the Collaborative Institutional Training Initiative (CITI) training must be completed for all members of the research team but does not need to be attached in the protocol package.
- Who can answer questions about the protocol?
You may discuss your proposed project with the Office of Research Integrity – Human Subjects Research. To obtain guidance regarding your protocol package, contact the office staff at 702-895-2794.
- When are the IRB meetings?
Meetings for each IRB are held once a month. See the IRB meeting schedule for both the Social/Behavioral and Biomedical IRB meetings for protocols requiring full board review. For review at a full board meeting, you must submit your protocol by the listed deadline (approximately one month prior to the board meeting).
- How is the level of review for my protocol determined?
The level of risk to the human subject and the type of research conducted determines the type of review needed for the protocol. Any protocol having more than minimal risk will require full-committee review. Any protocol having minimal risk may qualify for expedited review or exempt certification. Researchers cannot determine the level of IRB review necessary; the type of review required for a protocol will be determined by the office and/or chair or an appointed member of the appropriate IRB.
The Office of Research Integrity – Human Subjects Research can give you information about the type of review your protocol may receive. Please call the office at 702-895-2794 for more information.
- How long will the review process take?
If the protocol involves educational testing or survey procedures, does not use identifying information that can link subjects to data, and the subjects are healthy adult volunteers, the protocol may be exempt from full review. This type of protocol is reviewed through the expedited or exempt review process. You will be notified of its status within 21 business days.
However, if the protocol involves invasive procedures and/or vulnerable subjects such as minors, prisoners, or mentally disabled persons, full review by the appropriate Institutional Review Board (IRB) may be required. The IRBs have monthly scheduled protocol review meetings. Protocols requiring full board review must be received in the Office of Research Integrity – Human Subjects by the due date listed on the IRB meeting schedule in order to meet the deadline for a given meeting.
- How will researchers be notified of the status of their protocols?
An email will be sent to the principal investigator regarding the status of the protocol after it has been reviewed initially. The IRB can issue an approval, approval with minor revisions, a tabling of the protocol, or a disapproval of the protocol. Others involved in the protocol, including student researchers, protocol coordinators, and co-PIs, will be cc’d on the email to the PI. The status of a protocol in CyberIRB® is updated automatically.
- Who are the IRB members?
The IRB is composed of faculty affiliated with the social, behavioral, and biomedical sciences at UNLV and representatives from the community. Membership on the IRB is an annual appointment by the UNLV Institutional Official.
- What about research involving the Clark County School District?
Projects involving students, faculty, or staff of the Clark County School District must first be approved by the appropriate UNLV IRB. The protocol is then reviewed by the CCSD Research Review Committee. To learn more about this subject, see the CCSD Research Review Process website.
- Does a pilot study need to be reviewed by the IRB?
Yes. The number of participants does not determine if review is needed. The determining factor is whether or not human subjects are involved in research.
- If I am using a pre-existing data set with or without identifiers, do I have to get IRB approval?
Yes. Anytime you are conducting a systematic investigation involving data from human subjects that will contribute to generalizable knowledge, IRB approval must be sought. If the data set does not have any identifiers, then it will most likely fall into the exempt category. (IRB review is still required to certify that the study is exempt.) The IRB will ask the PI to specify where the data was obtained and under what circumstances, and to specify the data points that will be evaluated. If the data set does contain identifiers the study may fall under the category of expedited review. All application must specify how access to the data was gained.
- If I am doing research on samples obtained from cadavers, do I need IRB review?
If the samples were obtained while the subject was living, IRB review would be required.