Office of Research, UC Riverside
Office of Research Integrity

Institutional Review Board Socio-Behavioral (IRB-SB)

About IRB-SBImage result for social science research

The Institutional Review Boards (IRB) are 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 two IRBs, IRB-SB (socio-behavioral) and IRB-Clin (clinical-biomedical).  IRB-SB functions as the review body for the approval and oversight of socio-behavioral research at UCR. The primary mission of the Institutional Review Boards (IRB's) 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 IRBs strive 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 Integrity (ORI).  All human subjects research must receive prior approval from one of the IRBs.

If you are unsure, you can fill out and submit the Determination of Activity form found on our 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.

Do I have to submit to the IRB-SB (as opposed to the IRB-Clin)?

The IRB-SB reviews research employing:

  1. Surveys / questionnaires
  2. Interviews
  3. Focus groups
  4. Human factors evaluation

Research on individual or group characteristics or behavior, including, but not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior

Collection of data from voice, video, digital, or image recordings made for research purposes

If any of the above procedures are conducted IN ADDITION to the following procedures, the review will be completed by IRB-Clin:

  1. Skin Penetration (including blood draw) or penetration of tissue inside an orifice (e.g., blood samples, biological samples or swabs, skin or tissue biopsies outside of normal shedding)
  2. Application of heat (e.g., exposing participants to heat exposure to determine heat stress, or tolerance of high temperatures)
  3. Application of cold (e.g., cold or freezing temperature exposure to determine tolerance or biological effects)
  4. Application of electric current & electromagnetic fields (e.g., medical device use such as EKG, EEG or MRI)

For help in determining which IRB will be reviewing your application, please see below a comparison table. Keep in mind that depending on the complexity and risk levels associated with your study, the ORI will categorize your application submission for review. If you are unsure, please contact our office.

Applications that involve:

IRB-SB

IRB-Clin

Focus groups, surveys and interviews are conducted with or without participant identifying information

Focus groups, surveys and interviews are conducted and include blood draws, application of heat, cold or electric current

Focus groups, surveys and interviews are conducted and participants are asked to provide biological samples or biopsies

Participants will be monitored by EEG, EKG, MRI, X-Ray and/or other medical devices

Participants will be subjected to mild electric shock, as part of study interactions

Research involving materials (e.g., data, documents, records) that have been collected or will be collected solely for research purposes

Surveys asking about participant health, drug use, or other medical information

Research asking how participants feel about investigational drugs or devices

Research asking participants to use an investigational drug or device

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:

Minimal Risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinalrily encountered in daily life or during the performance of routine physical or phsychological examinations or tests [45, CFR 46, 102(i)].

The UCR Minimal Risk Tip Sheet is a tool developed by ORI to help the researcher determine what level of risk their study 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 46.101(b).  Applications are generally reviewed by a delegate process of IRB review.

Exempt

Studies meeting specific criteria as outlined in 45 CFR 46.110. 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 an Exempt determination on their own, nor does the University. You must submit the study 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 or prisoners as subjects
  • Involves the collection of Protected Health Information (PHI)
  • Most uses of deception

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

IRB applications can be found on our Forms Page. You may submit these forms electronically to: IRB@ucr.edu. Additional information such as the Informed Consent Guide and the Request for Determination of Activity forms can also be found on our Forms Page.

How to fill out and submit an application

To fill out an application for the IRB-SB, please complete the Application Form for Use of Human Participants and Project Roster. Once the form has been 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, the researchers may be asked to make changes to the submission before it is reviewed by the IRB (pre-review). Once the researcher addresses the pre-review comments, the IRB then reviews the revised application.  The IRB reviewer(s) may also ask for changes or clarifications, which the IRB analyst will communicate to the research team after IRB review (post-review). See our “Top Reasons an Application is Delayed” for more information.

As detailed in the above “Categories of Review" section, there are three types of IRB reviews 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 your application and workload in the office, additional time may be necessary to conduct an appropriate review.

Level of Review

Average Review Times

Full Board

For Full Board review, IRB comments will be forwarded to you within 1-2 weeks following the regularly-scheduled monthly meeting. Please see below the schedule of IRB-SB meetings & submission deadlines.1

Expedited

Submissions for expedited review are currently taking approximately four weeks to be processed and reviewed. Rolling submissions accepted.

Exempt

Requests for exemption determinations review are currently taking approximately three weeks to complete. Rolling submissions accepted. You still must submit an IRB application to get an 'exempt' determination.

Schedule of IRB-SB Meetings & Submission Deadlines for Full Board Reviews

Submission Deadline Dates

For IRB applications that require Full Board Review (Deemed to be more than minimal risk)

Submit by 3PM - the latest

 

2016 - 2017

IRB-SB Meeting Dates

February 27, 2017

March 13, 2017

March 20, 2017

April 10, 2017

April 17, 2017

May 8, 2017

May 22, 2017

June 12, 2017

No July Full Board Meeting

No July Full Board Meeting

July 24, 2017

August 14, 2017

August 21, 2017

September 11, 2017

September 18, 2017

October 9, 2017

October 23, 2017

November 13, 2017

November 20, 2017

December 11, 2017

December 18, 2017

January 8, 2018

For other application types that the ORI has determined full board review is not required (i.e., minimal risk), anticipate the entire review
and approval process to take approximately 3-4 weeks. Applications should always be sent in well ahead of any
research to be conducted.

~ Important points to keep in mind ~

1The IRB-SB normally meets once every month, on the 2nd Monday of the month. In order for an application to be placed on the agenda for a meeting, the researcher should plan to submit the application well in advance of the anticipated study start and adequately address any issues raised during the review process.

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

You may receive a request 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 and you will be given a deadline by which you need to respond. Once you satisfactorily respond, the ORI will move your application along the review process.

IRB Consults & Contact Information

University of California, Riverside
Office of Research Integrity
900 University Ave.
216 University Office Building
Riverside, CA 92521
Phone: 951-827-4802
IRB@ucr.edu

The Office of Research Integrity offers IRB consulting services to UCR investigators and research staff preparing IRB submissions (new studies, amendments) or preparing responses to review comments. This complementary service is provided to you by staff of the ORI. 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 at least on of the following two courses:
  • 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.

Important additional information for Researchers

 

Board Member Resources

 

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