Office of Research, UC Riverside
Office of Research Integrity

Institutional Review Board - Clinical-biomedical (IRB-Clin)

IRB-Clin

About IRB-Clin

The Institutional Review Boards (IRBs) 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-Clin functions as the review body responsible for the approval and oversight of clinical-biomedical research at UCR. Drug or devices trials (Phase I-IV) need to be submitted for review through the WIRB-Copernicus Group after contacting the Office of Research Integrity (ORI). For all Clinical Trials, researchers must first contact the ORI prior to submitting an application.

The primary mission of the IRBs 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 21 CFR 56), and supporting documents 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.

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

IRB-Clin reviews studies that involve:

  1. Use of a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
  2. The investigational use of a drug or device
  3. Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
  4. Any of the following procedures being done for research with no reasonable expectation that patient care will be improved or maintained:
    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)
    5. If treatment is being withheld (Including nutritional supplements, pharmaceuticals and studies with treatment arms where cohort will not receive the investigational agent)

For help in determining which IRB will be reviewing your application, please see below a comparison table. Depending on the complexity and risk levels associated with your study, the ORI will make the final determination regarding the IRB that a study application is relevant to.

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 an investigational drug or device or dietary supplement

Research asking participants to use an investigational drug or device or dietary supplement*

The severance or penetration or damaging of tissues of a human subject

*Note: For Clinical Trials, please contact the Office of Research Integrity at IRB@ucr.edu directly to arrange
an external review prior to submitting an application.

How to fill out and submit an application

To fill out an application for the IRB-Clin, please complete the Application Form for Use of Human Participants and Project Roster Form . Once the form has been completed and additional documents have been attached, please email us the application at 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.)

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 the 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 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:

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 can be found on our Resources Page.

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 “Top Reasons an Application is Delayed” for more information.

IRBprocess

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 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-Clin 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-Clin Meeting Dates

January 2, 2017

January 18, 2017

January 30, 2017

February 15, 2017

February 27, 2017

March 15, 2017

March 27, 2017

April 19, 2017

April 24, 2017

May 17, 2017

May 29, 2017

June 21, 2017

June 26, 2017

July 19, 2017

No August Full Board Meeting

No August Full Board Meeting

August 28, 2017

September 20, 2017

September 25, 2017

October 18, 2017

October 23, 2017

November 15, 2017

November 20, 2017

December 13, 2017

For other application types that ORI has determined full board review is not required, anticipate the entire review and
approval process to take approximately three to four weeks. Applications should always be sent in well ahead of any
research to be conducted.

~ Important points to keep in mind ~

1The IRB-Clin normally meets once every month, on the third Wednesday 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-served 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.

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

IRB Consults & Contact Information

University of California, Riverside
Office of Research Integrity
900 University Ave.
213 University Office Building
Riverside, CA 92521
Phone: 951-827-4802

IRB@ucr.edu

The Office of Research Integrity offers IRB consultations for UCR investigators and research staff preparing IRB submissions (new studies and amendments) or preparing responses to review comments. This complementary service is provided to you by ORI staff. 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 Intiiative (CITI) online course.
    • This training is only available to those with UCR email accounts
    • For IRB-Clin specific training, select the courses that specifically pertain to “Human Subjects Research for Biomedical Research Investigators".
  • IRB approval cannot be issued until the Lead Researcher and 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.

 

You can find information about WIRB and Clinical Trials here.

Where can I find additional information?

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

 

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