Institutional Review Board (IRB)

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About the IRB

The Institutional Review Board (IRB) is committed to following the federal regulations to protect the rights and welfare of human subjects involved in research conducted under the auspices of the University of California, Riverside (UCR). UCR upholds the highest standards in the ethical conduct of research, including the protection of human participants, while enabling its faculty, staff and students to conduct research in a timely and efficient manner.

UCR currently has one IRB which functions as the review body for the approval and oversight of all human subjects research at UCR. The primary mission of the IRB is to facilitate those objectives by reviewing, approving, modifying or disapproving research applications submitted by UCR researchers, and in some cases, non-UCR researchers. The IRB process is based on rules and regulations for federally funded research, primarily the provisions of Protection of Human Subjects in the Code of Federal Regulations (45 CFR 46), and supporting materials such as the Belmont Report. UCR’s IRB strives to create an on-campus culture of respect for, and awareness of, the rights and welfare of human research participants, while advancing knowledge and facilitating the highest quality research.

Do I have to submit an IRB application?

If your study meets the definition of human subjects research, you must submit an IRB application to the Office of Research Compliance. All human subjects research must receive prior approval from the IRB.

If you are unsure, you can fill out and submit the Determination of Activity form found in the IRB section of the ORI Forms Page. This form will assist the ORI in determining whether your activity meets the definition of ‘research involving human subjects' and requires IRB review/approval.

Categories of Review

The Level of Review

If your study needs IRB review, the next step is to identify the level of review required - Full Board review, Expedited review or Exempt certification.

The level of review usually reflects the level of risk to the subject. The risk level is compared to "minimal risk" research as defined by federal regulations:

The definition of Minimal Risk states: the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45, CFR 46, 102(j)].

The UCR Minimal Risk Tip Sheet is a tool developed by ORI to help researchers determine what level of risk their studies may fall under. You can use this form to help you make this determination as part of your research on human subjects study application.

Full Board	IRB applications that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a monthly convened IRB meeting. Examples of applications that may require full board review are studies using invasive procedures and research with investigational test articles.
Expedited	Minimal risk studies meeting specific criteria as outlined in 45 CFR 46.110. Applications are generally reviewed by a delegate process of IRB review.
Exempt	Revised Common Rule Studies originally approved on or after January 21, 2019, meeting specific criteria as outlined in 45 CFR 46.104(d) Exempt categories. Please note this excludes FDA regulated and DOJ funded studies. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB review continues unless the application is to be modified such that it no longer will meet the criteria for exemption.	Common Rule Studies meeting specific criteria as outlined in 45 CFR 46.101(b). The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB review continues unless the application is to be modified such that it no longer will meet the criteria for exemption.

Funding agencies do not allow investigators to make Exempt determinations on their own, nor does the University. Investigators must submit their studies to the IRB, which will make this determination. The IRB will NOT certify as exempt the following types of research at UCR:

More than minimal risk
Involves inpatients as subjects
Involves the intentional use of prisoners as subjects
Some uses of deception

IRB application Forms (“Where do I find these?”)

IRB applications can be found the IRB section of ORI's Forms Page. Submit completed forms to: IRB@ucr.edu. Additional information such as the Informed Consent Guide can be found on ORI's Resources Page.

How to fill out and submit an application

To fill out an application for the IRB, please complete the "Application Form for Use of Human Participants" and the "Project Roster" form (both on ORI's forms page). Once the forms are completed and the relevant additional documents have been attached, please email the application to IRB@ucr.edu.

Common mistakes that may delay your review and approval include not providing enough information pertaining to your study or not attaching all relevant documents requested/listed in the application form. (This includes all assessments or information given to participants.)

Timelines

The IRB utilizes an initial pre-review screening process whereby each application is reviewed for completeness and compliance. During this process, researchers may be asked to make changes to their submissions before being reviewed by the IRB (pre-review). Once the researchers address pre-review comments, the IRB then reviews the revised application. IRB reviewer(s) may also ask for changes or clarifications, which they will communicate to the research team after IRB review (post-review). See the “Top Reasons an Application is Delayed” for more information.

As detailed in the above “Categories of Review" section, there are three types of IRB review, as determined by the ORI. Depending on the level of review, the following timelines can apply. These review times are averages. Depending on the complexity level of the applications and the workload in the office, additional time may be necessary to conduct appropriate reviews.

Level of Review	Average Review Times
Full Board	For Full Board review, IRB comments will be forwarded to you within two weeks following the regularly-scheduled monthly meeting. Please see below the schedule of IRB meetings & submission deadlines.
Expedited	Submissions for expedited review are currently taking eight to nine weeks to be processed and reviewed. Rolling submissions ARE accepted.
Exempt	Requests for exemption determinations review are currently taking eight to nine weeks to complete. Rolling submissions are accepted. You must still submit an IRB application to get an 'exempt' determination.

Schedule of IRB Meetings & Submission Deadlines for Full Board Reviews

For other application types that the ORI has determined full board review is not required (i.e., minimal risk), the duration of the review and approval process will vary based on your study and may take several weeks. Applications should be submitted well ahead of any research to be conducted.

~ Important points to keep in mind ~

The IRB normally meets on the 3rd Monday of each month. In order for an application to be placed on the agenda for a meeting, researchers should plan to submit their applications well in advance of the anticipated study start and adequately address any issues raised during the pre-review process.

Depending on the complexity and risk levels associated with the study, the Office of Research Integrity will categorize the application submission for review. Applications will be reviewed on a first-come, first-served basis which also includes study amendment applications and continuing renewals. Therefore, the ORI highly recommends accurate and timely submission of the application and attachments to account for this review process.

Investigators may receive requests from the ORI to make changes to your submission during the pre-review screening process and/or after formal IRB Member/Board review. These comments must be addressed prior to IRB approval and a deadline for response will be provided. Once satisfactory responses are received, the ORI will move the application to the next step in the review process.

IRB Consults & Contact Information

University of California, Riverside
Office of Research Integrity
Phone: 951-827-4802
IRB@ucr.edu

The Office of Research Integrity offers IRB consultations for UCR investigators and research staff who are preparing IRB submissions (new studies, amendments) or preparing responses to review comments. Please email us at IRB@ucr.edu to set up an appointment to speak with an ORI representative.

Education & Training

Required Human Subjects Protection Training - All investigators and staff conducting human subjects research are required to complete the Collaborative Institutional Training Initiative (CITI) online courses.
- Researchers should select the courses that specifically pertain to their field or involvement in the human subjects research project. Options include:
  - Social & behavioral research investigators
  - Biomedical Research Investigators
  - Research with data or laboratory specimens ONLY
IRB approval cannot be issued until the Lead Researcher and faculty advisor/supervisor (if applicable) have completed the required ethics training
The Lead Researcher is responsible for ensuring the completion of Human Subjects Protection Training for all research personnel (including staff and students) involved in the research.

Where can I find additional information?

Researchers and committee members can find more information in the IRB section of the ORI Resources Page.