Institutional Review Board (IRB)/ Human Participants - (Cayuse IRB - Electronic Submission)

The CSUF Institutional Review Board (CSUF IRB) is a university committee appointed by the president to review and safeguard the use of human participants in research pursuant to Federal Code of Regulations (45 CFR 46Opens in new window ).

CSUF receives federal funding and agrees to adhere to the  Office for Human Research Protections (OHRP)  regulations for use of human subjects in research. In order to comply with the Department of Health and Human Services federal regulations regarding research involving human subjects, the university agrees that all CSUF protocols that involve human subjects will be reviewed for compliance with these regulations before each researcher begins data collection.

CSUF students, faculty or staff who conduct research involving human subjects, when such data will be available for generalized public knowledge and/or publication, require review and approval by CSUF IRB.

CSUF IRB has now upgraded to Cayuse Institutional Review Board (IRB) system, for online submission and processing of human subject research studies (protocols) in accordance with CSU, federal, ethical, and regulatory standards.

The Cayuse IRB module is an easy-to-use system for electronically preparing, submitting, and routing studies for IRB approval. All information is stored in the cloud and can be accessed securely from any location, making it simple for multiple simultaneous users to view and share documents. Users receive electronic notifications whenever an action is required on their part, allowing the study to proceed smoothly through each step of the process from study creation to final approval.

More information on all submission types available in Cayuse IRB can be found below in the Submission Types tab. Step by step instructions on how to submit new and/or modification, click on the quick links to the right of this page.

*Cayuse IRB runs on Internet Explorer 9 or higher, Mozilla Firefox, Google Chrome, or Apple Safari.

Office:  657-278-7719

Email:   irb@fullerton.edu

Titan Hall – ASC-228

Cayuse IRB Log-In Opens in new window

Authentication

If this is your first time submitting an IRB protocol in Cayuse IRB and/or are receiving the following message at log-in "We're sorry. This account has been disabled on the Cayuse424 system", please email the following information to irb@fullerton.edu requesting authentication for Cayuse:

  • First and Last Name
  • Fullerton email address (e.g. NAME100@csu.fullerton.edu)
  • Status (faculty, staff, student, unaffiliated, etc., as appropriate)
  • College and Department

All students planning on submitting an IRB protocol must submit the above information to the IRB office prior to accessing the Cayuse IRB system.

For studies that include students as research assistants, authentication of the students is not required, however, the research assistant's names must be listed on the application along with others engaged in the research.

Once the Research Compliance staff creates the authentication, the Cayuse system will update overnight prior to the PI accessing his/her account in Cayuse IRB.

Submission Requirements

Before beginning a submission, users should have the following items ready:

  • Supplemental documents in individual document files (i.e. informed consent forms, authorizations from collaborating agencies, approvals from administrators when appropriate, recruitment documents, questionnaires for data collection, scripts for interviews, etc.). PDF files are preferred. All templates can be found on the Consent FormsOpens in new window page.
  • Copies of current CITI training reports (NOT the certificate of completion) for principal investigator, faculty advisor, co-PI(s), student investigators, and all other engaged research personnel.
  • All users "authenticated" in the Cayuse IRB system
  • For more information, please see the Authentication tab
  • Letters of Support (on letterhead and assigned by appropriate official)

Is IRB Required?PDF File Opens in new window

Submission Types

Initial - This is the first submission that you create when you enter a new study in the system. The initial submission describes the research you intend to do and the methodology you intend to use. The initial submission must be approved before any research can begin.

Withdrawal - A withdrawal submission notifies the Research Compliance Office that you no longer wish to submit your initial submission and want to withdraw the study. Withdrawn studies are marked as finalized and can no longer be modified. You may create a withdrawal submission at any point once an initial submission has been created, until it has been approved. If the initial submission has been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research.

Legacy - Used for studies imported from previous systems, including the former CSUF paper based system. The legacy submission replaces the initial submission for imported studies. Once the legacy submission is finalized, you can create additional submissions such as modifications, renewals, etc.

Modification - If you wish to change any of the details of the study after it has been approved, you must submit a modification which must be approved before you can proceed with the changes. Modifications will only be available after initial approval is issued. Modifications will be linked with the initial application and you will make revisions to the initial application based on the modifications you are requesting.*

Renewal - When a study is nearing its expiration date, you must submit a renewal request in order to continue with the research. Expiration notices will be emailed from Cayuse. Renewals, like modifications, will only be available after initial approval is issued.*

Incident - You must submit an incident report to inform the IRB Office of any adverse incidents, as required by your institution. Incident reports may be submitted at any time after a study has been approved, including after it has been closed. More than one incident report may be created for a given study, as needed.

Closure - A closure submission indicates that the research is complete and will not be continuing. Closed studies are marked as finalized and can no longer be modified.

*At this time, CSUF will not make alterations, as per the Common Rule, in the process of modifying or renewing IRB applications.

Consent vs Assent

When executed properly, the informed consent process provides sufficient information about study procedures so that a potential participant can make a reasonable decision about participation, based on an understanding of the potential risks and anticipated benefits (if any) of the study. Informed consent is not a waiver of rights. 

Individuals who do not have the authority to consent to participate in research must still provide their assent.

CONSENT DOCUMENT

The CSUF IRB will review the consent document(s) for use in obtaining and documenting consent from study participants.  Consent forms must adequately describe the study using language appropriate for the target audience. If relevant, the investigator will be asked to translate consent documents into the subject's primary language after the English version of the consent form has received CSUF IRB approval. Both the English version and translated version are required prior to the CSUF IRB issuing an Approval Notice.

Templates and SamplesOpens in new window

ASSENT PROCESS

Assent is an active affirmation of a desire to participate and differs from consent, which is recognized as being granted from an individual with the legal authority to do so. Even very young children or those with limited cognitive ability can assent and can certainly indicate a desire not to participate, which must be honored. Assent should be administered in a manner that is easily understood by the potential participant (either written or verbal) and should be limited to a one-page format. Illustrations might be helpful and larger type makes it easier for some individuals to read.

Templates and SamplesOpens in new window

The following additional information relates to minor participants but can be adapated accordingly for use with adult individuals wherein assent is necessary:

ASSENT FROM CHILDREN ( 45 CFR 46.408 )

Assent from a minor must be obtained in a language that is understandable to him/her and which requires use of an age-appropriate assent form (either verbal or written) instead of a consent form used to obtain permission from the minor's parents(s) or guardian(s). 

Assent is demonstrated by a child's agreement to participate in research. In California, a child is a person who is under the age of 18 years (unless legally emancipated). It is required that the researcher make adequate provisions to solicit assent. 

The CSUF IRB will review a description of the process and procedures for obtaining assent from the child. To determine whether the child is able to assent depends on the child's age and maturity. If the child is considered capable of providing assent, whether or not assent is documented, is also determined by the IRB. Generally, children are able to read and write to some extent by age seven. As such, documenting assent by having the child sign an assent form is usually a procedure that is incorporated for children ages 7-17. When documentation is not required, the IRB requires that the investigator conduct the assent process through a verbal script, and the IRB will review the script of what will be said during the verbal consent process. It is also recommended that investigators avoid such language as, "Your mom or dad said it is okay for you to participate," since this language can be deemed coercive.

Review Process

When you submit your application, the CSUF IRB will determine which federal category it applies to for review — exempt, expedited or full committee. If your application is incomplete or additional information or revisions are needed in order to continue the review process, you will be contacted at the email address on your application. If you are a student, the IRB coordinator may also copy your faculty adviser on correspondence as a courtesy. 

Exempt or Expedited categories: expect to receive your approval notice and approved consent forms, if applicable, within 2-3 weeks. If the CSUF IRB has requested that you supply additional information or revisions in order to approve your application, this process can take longer. If the CSUF IRB does not receive a response or the requested information within a timely manner, you may be notified that your file has been closed, and a new application will be required for resubmission.

Full Committee  review: your application will be placed on the agenda for the next CSUF IRB meeting, which corresponds with the submission deadlines. A primary reviewer will be assigned to review your application, and you will be contacted by this reviewer prior to the meeting if additional information or concerns apply. Your attendance is not required at the meeting unless requested by your primary reviewer. After the CSUF IRB has reviewed and voted on your application, you will be notified by email of the outcome of the vote. If additional revisions or information are requested, submit them to the CSUF IRB within a timely manner. If the CSUF IRB has voted to table discussion of your application pending receipt of additional information or revisions, your application will be placed on the agenda for the next meeting.

This information is subject to change. If you have questions or require additional assistance regarding the CSUF IRB, please contact us at irb@fullerton.edu.

Expiration and Renewal Notices

All Expiration and Renewal Notices are being emailed through Cayuse IRB production site. Cayuse IRB will send a reminder notice 60  days before a protocol expires, so that the PI(s) have adequate time and opportunity to renew the expiring protocol. 

NOTEIt is the PI's responsibility to renew his/her protocol before it expires.*

PIs can begin renewal submissions once their legacy submission is completed by the IRB office. The legacy is used for studies imported from previous systems and replaces the initial submission for imported studies. Once the legacy submission is finalized, PIs can create additional submissions such as modifications, renewals, etc.

* CSUF is not currently implementing the Common Rule changes.

IRB Members

Member Name

Department

E-Mail

Justine Baldacci, MPH

Environmental Health and Safety

jbaldacci@fullerton.edu

Rebecca Bodan, Ph.D.

Nursing

rbodan@fullerton.edu

Richard Boucher, MD.

Student Health Center

rboucher@fullerton.edu

Ioakim Boutakidis, Ph.D.
Vice-Chair

Child and Adolescent Studies

iboutakidis@fullerton.edu

Pablo Costa, Ph.D.

Kinesiology (Alternate)

pcosta@fullerton.edu

Matt Englar-Carlson, Ph.D. Chair

Counseling

mattec@fullerton.edu

Russ Espinoza, Ph.D.

Psychology

ruespinoza@fullerton.edu

Jorge Fontdevila, Ph.D.

Sociology

jfontdevila@fullerton.edu

Andrew Galpin, Ph.D.

Kinesiology

agalpin@fullerton.edu

Barbara Glaeser, Ph.D.

Special Education

bglaeser@fullerton.edu

Maureen Jakocko, RN

Community Member Representative

 

Edythe Krampe, Ph.D.

Sociology (Alternate)

ekrampe@fullerton.edu

Robert Lockie, Ph.D .

Kinesiology

rlockie@fullerton.edu

Carol Lundberg, Ph.D.

Educational Leadership

clundberg@fullerton.edu

Michelle Martin, Ph.D. 

Social Work

mimartin@fullerton.edu

Nancy Panza, Ph.D.

Psychology (Alternate)

npanza@fullerton.edu

Lee Ann Stone, Ed.D.

Community Member Representative (Alternate)

 

Veronica Thomas, Ph.D.

Prisoner Advocate Member

vtpeterpan@aol.com

IRB Meetings

A full committee review is required when:

  • Projects involve minors (except where standardized or education tests only are being administered);
  • More than minimal risk to subjects is involved (CSUF IRB includes exercise studies and/or studies where blood will be drawn from subjects);
  • Subjects are mentally and/or physically challenged;
  • Prisoners as subjects; and/or
  • Research is of a controversial nature.

If your protocol fits the above criteria, or you think it will require full committee review, please make sure that an original application (plus 15 copies) is submitted by the following deadline(s).

Remember: Official determination of full committee review is made AFTER your application has been received and reviewed by the Regulatory Compliance Coordinator.

CSUF IRB Meeting Schedule

These dates may be subject to change. Researchers should check this site frequently to up-to-date information about meeting and/or submission deadlines.

Submission Deadline

IRB Meeting

Feb. 23, 2018 by noon

March 9, 2018 10 a.m-noon

March 30, 2018 by noon

April 13, 2018 10 a.m-noon

April 27, 2018 by noon

May 11, 2018 10 a.m-noon

May 25, 2018 by noon

June 8, 2018 10 a.m-noon

No meeting July 2018

No meeting July 2018

July 27, 2018 by noon

Aug. 10, 2018 10 a.m-noon

Aug 31, 2018 by noon

Sept. 14, 2018 10 a.m-noon

Sept. 28, 2018 by noon

Oct. 12, 2018 10 a.m.-noon

Oct. 26, 2018 by noon

Nov. 9, 2018 10 a.m.-noon

Nov. 30, 2018 by noon

Dec. 14, 2018 10 a.m.-noon

Note: Full Board applications including new, continuing reviews and amendments(more than minimal risk) are reviewed on the above dates when a quorum is present. Exempt and Expedited applications (minimal risk) can be submitted to the IRB office any time.

Cayuse IRB Training

All CSUF faculty, staff, and faculty advisors who provide direct oversight of research for students should attend a Cayuse IRB training workshop to learn about the transition from the paper based application submission process to the new electronic submission process.

The workshop will cover the new account authentication process, provide an overview of the new layout, step-by-step instructions on how to submit a protocol, making edits as well as submitting amendments and renewals online.

Workshops are open to all faculty/staff through the Faculty Development Center on the following dates/times*:

Date

Time

Location

Friday, Feb. 23

Monday, Feb. 26

Tuesday, March 6

Wednesday, March 14

Thursday, March 22

11:30 a.m.-1 p.m.

11 a.m.-12:30 p.m.

1-2:30 p.m.

1-2:30 p.m.

10-11:30 a.m.

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