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.

Step One: Determine if you need to submit an IRB protocol

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

If you are unsure, you can complete and submit a Not Human Subjects Research (NHSR) Determination (formerly Determination of Activity or DOA) through the online IRB protocol submission system, Kuali. This submission type will assist the ORI in determining whether your activity meets the definition of ‘research involving human subjects' and requires IRB review/approval. For new submissions, please access UCR's Kuali Protocol Page.

Systematic Investigation	Attempts to answer research questions Is methodologically driven Data is analyzed in a disciplined way Conclusions are drawn from the results
Generalizable Knowledge	Activities are primarily designed to develop new knowledge or activities as part of a thesis, dissertation, coursework or degree requirements This can also include knowledge intended to be published or shared outside of the local context
Human Subject	Living individual(s) about whom an investigator conducting research: obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Human Subjects Research	Requires prior review and approval by an IRB. Contact the Office of Research Integrity to ensure protection of your participants and also to adhere to Federal Regulations surrounding your research

Step Two: Determine the Review Level

If your study needs IRB review, the next step is to identify the level of review required:

• Full Board review
• Expedited review
• 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:

Definition of Minimal Risk

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.

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

Step Three: Complete IRB Application Forms

For new submissions, please access UCR's Kuali Protocol Page. 

To submit a protocol for IRB review, please access the IRB protocol form through the Kuali system and select “IRB Human Subjects Review” as the submission type. Submission of the protocol occurs directly within the system. 

For information regarding available training opportunities, please see below resources.

Kuali IRB Resources:

• Kuali IRB FAQs
• Kuali IRB Training Videos and Guides
• Kuali Assistance and Consultations

Common mistakes that may delay your review and approval include not providing enough information pertaining to your study or not submitting all relevant documents requested/listed in the protocol 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.
 

IRB Process Flowchart

As detailed above in "Review Levels", 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.

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.

Step Four: Complete 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.
   

Additional Information

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