Institutional Review Board | CSUF - Office of Research and Sponsored Programs

Revised Common Rule

The federal policies mandating the protection of human subjects are known as the “Common Rule,” and on January 21, 2019, a substantial revision to the Common Rule went into effect. These changes are meant to ease some researcher burden while enhancing the protection of human subjects and apply only to new studies submitted on or after January 21, 2019. Please note: the revised Common Rule does NOT apply to Federal Drug administration (FDA) regulated and Department of Justice studies.

CITI Training & Revised Common Rule

The CITI Program has updated their current modules to reflect the changes to the Common Rule, which will not affect the module assignments required by CSUF IRB. Next time you are due for training, you will see the latest content.

Changes to Definitions of Research

The Revised Common Rule contains a more detailed definition of "research", specifically pointing out certain areas that are NOT "research". So what's not research?

Scholarly and journalistic activities focused directly on the specific individuals about whom the information is collected (i.e., oral history).
Public health surveillance conducted, supported, requested, ordered, required, or authorized by a public health authority.
Collection and analysis of information or biospecimens for a criminal justice agency authorized by law or court order solely for criminal justice or criminal investigative purposes.
Authorized activities in support of intelligence, homeland security, defense or other national security interests.

Expedited Review

Changes: No continuing review required of expedited research unless the IRB documents a rationale for requiring it.
Summary of Expedited Categories (unchanged).

Informed Consent Changes

There are some changes to the process of informed consent. These changes are highlighted on the CSUF informed consent templates. These include:

Informed Consent must specifically give prospective participant(s) the information that a reasonable person would want to have to make an informed decision about whether to participate. Using this standard, Informed Consent remains focused on what information a reasonable person would want to have to make an informed choice about participation.

An additional change is that the information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate in the proposed research.

The informed consent needs to include a notice about whether participants' information or biospecimens collected as part of the current research might be stripped of identifiers and used for other research in the future. The purpose of this is to increase transparency by letting participants know that it might happen.

Renewals

Under the Revised Common Rule, continuing review/renewal is not required for:

Research that is eligible for expedited review (unless the IRB documents a need for continuing review).
Exempt research conditioned on limited IRB review.
Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable- this includes Full Committee Review applications.
Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

Importantly, the IRB can override this default and still choose to require continuing review, as long as the IRB documents the decision and the rationale for this decision.

For CSUF, this means that human subjects research classified and approved as exempt (limited IRB review) and expedited will no longer need to be renewed on an annual basis. The initial approval will suffice for the duration of the research unless there is a change to the research a modification/amendment request will be required.

IRB Review Categories

Upon receipt of your protocol, the study will be assigned to an Analyst and a Primary Reviewer. If your protocol is incomplete or additional information or revisions are needed, the protocol will be returned electronically via the Cayuse Human Ethics system. You will be able to access your protocol through the dashboard to review the comments provided by the Primary Reviewer.

When you submit your application, the CSUF IRB will determine which federal review category it applies to for review (Exempt, Expedited, or Full Committee).

Exempt or Expedited Categories

Exempt and Expedited studies are accepted and reviewed on an ongoing basis. Approvals for studies under these two categories may be issued within ~15 business days from the initial submission date. If the CSUF IRB has requested that you provide additional information or revisions in order to approve your application, this process can take longer.

Full Committee Review

Studies requiring Full Review are due two weeks prior to the scheduled IRB Full-Review meeting. Review the Full-Review Meetings and Deadlines tab for the schedule of upcoming IRB Full-Review meetings. Applications will be placed on the agenda for the next CSUF IRB meeting, which corresponds with the submission expiration and renewal notice. A primary reviewer will be assigned to review your application, and you will be contacted by the 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 and/or information is requested, upload the revisions directly onto Cayuse IRB's online application within a timely manner. If the CSUF IRB has voted to table discussion on your application pending receipt of additional information or revisions, your application will be placed on the agenda for the next meeting.

IRB Basic Steps

The IRB Basic Steps will guide you through the IRB process in determining if an IRB submission is required for your study all the way through the approval process. Reviewing each of the steps above will prepare you with compiling the information you need to prepare your protocol, provide you with direction on how to submit a Cayuse IRB application, as well as guidance after you have received an initial approval on how to submit a request for a modification, renewal or closure.

DOES MY STUDY REQUIRE IRB?

The Revised Common Rule contains a more detailed definition of "research", specifically pointing out certain areas that are NOT "research." So, what is not research?

Scholarly and journalistic activities focused directly on the specific individuals about whom the information is collected (i.e., oral history).
Public health surveillance conducted, supported, requested, ordered, required, or authorized by a public health authority.
Collection and analysis of information or biospecimens for a criminal justice agency authorized by law or court order solely for criminal justice or criminal investigative purposes.
Authorized activities in support of intelligence, homeland security, defense or other national security interests.

To determine if your study is research, review the CSUF IRB Flow Chart.

BELMONT REPORT

The Belmont Report was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The primary purpose is to protect subjects and participants in clinical trials or research studies. This report consists of 3 principles: beneficence, justice, and respect for persons. For additional information, review the Belmont Report and/or view the video describing the basic ethical principles that underlie research involving human subjects and demonstrates how they can help resolve ethical conflicts in research. Visit the Office for Human Research Protections website.

Belmont Report

Step 1: Before you get started

All Principal Investigators (PIs) will need to have an account set up through the Cayuse IRB as well has have completed the required Collaborative Institutional Training Initiative (CITI) for CSUF IRB.

Review the two sections below for more details on these two requirements as you get started with the IRB process.

Authentication: If this is your first time submitting a protocol via Cayuse IRB, email the following information to irb@fullerton.edu requesting authentication for Cayuse IRB:

First and Last Name
CSU Fullerton email address (e.g. NAME100@csu.fullerton.edu)
Status (e.g. faculty, staff, student)
CWID
College and Department Name

Or complete the following form: Request a new Cayuse IRB Log-In

For studies that include students as research assistants, authentication of the students is not required, however, the research assistant name(s) must be listed on the application along with anyone else who is engaged in research along with uploading the required CITI training for each person.

NOTE: Please allow 1-2 business days for the IRB office to create new Cayuse accounts.

CITI Course Required by CSUF
The Collaborative Institutional Training Initiative (CITI) Program is a leading provider of research education training. It provides online training modules on a variety of topics related to research, including the required training for CSUF Human Ethics. All investigators, co-investigators, coordinators, and key personnel conducting research on human participants are required to complete the Social & Behavioral for Research Investigators training course. This includes anyone who will be directly responsible for study management, data collection, consent process, data analysis, transcription, participant recruitment or follow up. The CSUF IRB requires re-training every five years.

A minimum score of 80% on the final score and the scores of all the individual modules is required by CSUF IRB.

Be aware that completing the required modules for Social & Behavioral for Research Investigators takes about two to three hours to complete; all modules do not have to be completed during a single online session. To re-enter the course, you will be able able to log back in with the username and password you created when you set up your initial CITI Program account.

NOTE: An IRB application cannot be processed until all personnel have completed the required CITI Training.

Step-by-step instructions on how to create a CITI Program account and register for the correct course for IRB can be downloaded below.

After completing the training, you will be able to download a PDF of the detailed Completion Report to upload onto your online Cayuse IRB application under the Introduction section.

The CSUF CITI modules are specific to the CSUF IRB requirements. Other agencies and institutions may have their own requirements and are not obligated to accept completion of the CSUF CITI training in place of those requirements. When conducting research with another institution or in conjunction with another agency, you may be required by the institution or agency to complete their specific training requirements (such as additional CITI modules), and/or complete refresher courses according to their renewal requirements (which may be more frequent than the CSUF requirement of every five years).

Step 2: Preparing your IRB (Gathering Your Documents)

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

Project Description/Methods - All PIs requesting IRB review of their project/research activity must prepare a detailed description of their project/research which provides the committee with the information about the purpose, method of data collection, and measures taken by the PI to protect human subjects.
Supplemental documents - PDF files are preferred . Upload the following documents into your online application:

- Informed Consent forms - templates provided below
- Letters of Support from collaborating agencies authorizing the research at their institution (including CSUF departments working with PI to disseminate surveys and/or recruitment material to students across campus). Must be on official letterhead. No emails .
- Approvals from administrators when appropriate. Must be on official letter head. No emails.
- Recruitment documents.
- Questionnaires/Surveys - for data collection.
- Scripts for interviews, etc.
- Debriefing documents - if applicable.

NOTE: If the study calls for translated documents, all documents must be uploaded at the time of submission.

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.

NOTE: Approved assent and consent forms will no longer be stamped.

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. Both the English version and the translated version are required prior to the CSUF IRB issuing an approval notice.

Customize the sample Consent Form below for participants consenting for themselves who are 18 years of age or older.

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 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.

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 require use of an age-appropriate assent form (either verbal or written) instead of a consent form used to obtain permission from the minor's parent(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 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, the children are able to read and write to some extent by age seven. As such, documenting assent by having a child sign an assent form is usually a procedure that is incorporated for children ages 7-17. When documentation is 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 the language can be deemed coercive.

Assent Form Templates:

Assent Forms
Age Group	English	Spanish
Ages 6 - 11	Assent Form (English)	Assent Form (Spanish)
Ages 12 - 14	Assent Form (English)	Assent Form (Spanish)
Ages 15 - 17	Assent Form (English)	Assent Form (Spanish)

Parental Consent Form Templates:

Step 3: How to Submit a Protocol Using Cayuse IRB

CSUF IRB has 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 users to simultaneously 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.

Step-by-step instructions on how to create an Initial Submission can be reviewed in the following PDF document:
Cayuse IRB Protocol Submission (User Guidelines)

For additional guidance on how to address reviewer feedback, access the step-by-step instructions for Cayuse IRB: Addressing Primary Reviewer Comments

In addition, the video tutorial below will guide users through the step-by-step process outlining the entire IRB Cayuse application : User - How to Complete a Cayuse IRB Application (41:07)

Or click below to reference a specific section of the application.

0:00 - Creating an application
1:21 - Introduction
10:28 - Funding Information
12:49 - Project Description
15:19 - Participant Information
20:12 - Data Collection
27:25 - Risk and Benefits
29:55 - Informed Consent Process
33:34 - Anonymity and Confidentiality
36:51 - Subject Matter
37:18 - Debriefing
37:49 - Conflict of Interest
39:25 - Submitting and Certifying the Application
40:48 - Questions or Concerns

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

AFTER APPROVAL: Submitting a Modification, Renewal, or Closure

After a PI has received an Initial approval for their study, they may officialy begin their research. PI's may find that they need to submit a Modification, Renewal, Incident, or Closure. More information on all submission types available in Cayuse IRB can be found below.

In addition, all Expiration and Renewal Notices are emailed to the PI through the Cayuse IRB production site. Cayuse IRB will send reminder notices 60 and 15 days before a protocol expires, so that the PI(s) have adequate time and opportunity to renew the expiring protocol.

NOTE: It is the PI's responsibility to renew their protocol before it expires.

Cayuse IRB Submission Types

When you first create your study in the system, you are creating the Initial Submission for the protocol. In addition to the Initial Submission, there are five other types of submissions that you may submit during the course of your study. The additional submission types include:

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. For additional guidance, access the step-by-step instructions for Cayuse IRB: Initial Submission (user guide).

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 had been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Withdrawal Notification.

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. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Modification.

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. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Renewal.

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. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting an Incident Report.

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. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Closure Request.

citi-training

IRB CITI Training

The Collaborative Institutional Training Initiative (CITI) Program is a leading provider of online research education training. It provides online training on a variety of topics related to research including the required training for CSUF IRB. All investigators, co-investigators, coordinators, and key personnel conducting research on human participants require the completion of the Social & Behavioral for Research Investigators training course. This includes anyone who will be directly responsible for study management, data collection, consent process, data analysis, transcription, participant recruitment or follow up. The CSUF IRB requires re-training every five years.

A minimum score of 80% on the final score and the scores of all the individual modules is required by CSUF IRB.

Be aware that completing the required modules for Social & Behavioral for Research Investigators takes about two to three hours to complete; all modules do not have to be completed during a single online session. To re-enter the course, you will be able to log back in with the username and password you created when you set up your initial CITI Program account.

NOTE: An IRB application cannot be processed until all personnel have completed the required CITI Training.

Step-by-step instructions on how to create a CITI Program account and register for the correct course for IRB can be downloaded below.

After completing the training, you will be able to download a PDF of the detailed Completion Report to upload onto your online Cayuse IRB application under the Introduction section.

The CSUF CITI modules are specific to the CSUF IRB requirements. Other agencies and institutions may have their own requirements and are not obligated to accept completion of the CSUF CITI training in place of those requirements. When conducting research with another institution or in conjunction with another agency, you may be required by the institution or agency to complete their specific training requirements (such as additional CITI modules), and/or complete refresher courses according to their renewal requirements (which may be more frequent than the CSUF requirement of every five years).

IRB Committee Members

The President of CSUF appoints the CSUF IRB members in accordance with federal requirements (45 CFR 46). The CSUF IRB is composed of members representing the University faculty, staff and local community. Membership includes at least one individual whose primary concerns are in the nonscientific areas and at least one member not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution. The faculty members represent a variety of disciplines representative of the research being reviewed. In addition to the federal policy the CSUF IRB composition may also include a student representative and directors (or their designated representative) from each of the following departments: Student Health and Counseling, Environmental Health & Safety; Grants & Contracts (UPS 620.000).

Committee Members
Member	Department	Email
Matt Englar-Carlson, Ph.D., Chair	Counseling	mattec@fullerton.edu
Ioakim Boutakidis, Ph.D., Vice Chair	Child and Adolescent Studies	iboutakidis@fullerton.edu
Lucia Alcala, Ph.D.	Psychology	lualcala@fullerton.edu
Justine Baldacci, MPH	Environmental Health and Safety	jbaldacci@fullerton.edu
Rebecca Bodan, Ph.D.	Nursing	rbodan@fullerton.edu
Pablo Costa, Ph.D.	Kinesiology (alternate)	pcosta@fullerton.edu
Brittany Eghaneyan, Ph.D.	Social Work	bheghaneyan@fullerton.edu
Jorge Fontdevila, Ph.D.	Sociology	jfontdevila@fullerton.edu
Maureen Jakocko, RN	Community Member Representative
Zac Johnson, Ph.D.	Human Communications Studies	zjohnson@fullerton.edu
Robert Lockie, Ph.D.	Kinesiology	rlockie@fullerton.edu
Ann Luecha, MD	Student Health Center	aluecha@fullerton.edu
Jessie Peissig, Ph.D.	Psychology (alternate)	jpeissig@fullerton.edu
Rogelio Serrano	Prisoner Advocate Member	rogelio_serrano@sbcglobal.net
Nancy Watkins, Ph.D.	Educational Leadership	nwatkins@fullerton.edu
Jessi Pham	Student Representative	jessihp@csu.fullerton.edu

IRB Full-Review Meetings and Submission Deadlines

Exempt and Expedited applications (studies with minimal risk) can be submitted via the Cayuse Human Ethics online application system at any time, and they will be reviewed as they come in.

Full Board applications including new, continuing reviews, and amendments (more than minimal risk) are reviewed on the following dates below when a quorum is present.

A full committee review is required when:

Projects involve minors (except where only standardized or educational tests 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, Parolees or Incarcerated Participants as subjects; and/or
Research is of controversial nature.

Remember: Official determination of full committee review is made AFTER the application has been received and reviewed by the IRB Office.

These dates may be subject to change. Researchers should check this site frequently to view up-to-date information about meeting and/or submission deadlines. The dates and deadlines indicated in the table below only apply to protocols in the Full Committe Review Category.

CSUF Full-Review IRB MEETING SCHEDULE
Month	Submission Deadline	IRB Meeting
July 2024		NO MEETING
August 2024	July 26, 2024, by noon	August 9, 2024
September 2024	August 30, 2024, by noon	September 13, 2024
October 2024	September 27, 2024, by noon	October 11, 2024
November 2024	October 25, 2024, by noon	November 8, 2024
December 2024	November 29, 2024, by noon	December 13, 2024
January 2025	January 3, 2024, by noon	January 17, 2025
February 2025	January 24, 2025, by noon	February 7, 2025
March 2025	February 28, 2025, by noon	March 14, 2025
April 2025	March 28, 2025, by noon	April 11, 2025
May 2025	April 25, 2025, by noon	May 9, 2025
June 2025	May 30, 2025, by noon	June 13, 2025
July 2025		NO MEETING

IRB FAQs

How do I request an IRB Cayuse Account?

In order to access the Cayuse system, you will need to have an account created and authenticated. Email irb@fullerton.edu and provide your name, CSUF email address, CWID, major/department, and if you are a student/staff/faculty or you can click the following link to request a new Cayuse IRB Log-In

Keep in mind that data cannot be collected until the researcher has submitted an IRB protocol that has been reviewed and by the IRB.

Why am I getting a message saying “We’re sorry. This account has been disabled on the Cayuse 424 system” when trying to log into Cayuse?

This message will appear when a user does not have a Cayuse IRB account. You will need to contact the CSUF IRB office to create and authenticate a Cayuse IRB account for you. Email irb@fullerton.edu indicating your name, CSUF email address, CWID, major/department, and if you are a student/staff/faculty or you can click the following link to request a new Cayuse IRB Log-In

How do I log into Cayuse?

Enter “CSUF IRB” in your search bar and select the first option. You will be directed to the main IRB page where you will find a link titled “Cayuse IRB Log-In”. After clicking the link, you will be directed to the Cayuse Log-In page. You may also click on the following link which will direct you to the Cayuse Log-In page: Cayuse Log-In

How do I find my advisor within the Cayuse application?

Click on “Find People” and type in the name of your advisor. If their name does not appear, then there is a possibility that the advisor does not have a Cayuse IRB account that has been set up yet. To have an account set up, email irb@fullerton.edu and provide your name, CSUF email address, CWID, major/department, and if you are a student/staff/faculty or you can click the following link: IRB Cayuse Authentication.

How to create a CITI Program account?

A CITI account can be created by registering on the CITI Program Webpage. For step-by-step instructions on how to create an account, visit the CSUF IRB CITI Training Webpage.

What CITI Training is required by the CSUF IRB?

CSUF IRB requires ALL personnel involved in research to complete the CITI training module titled, " Social & Behavioral Research Investigators " to provide training in the ethical use of human participants in research. Each module MUST be completed with a score of 80% or better. Step-by-step instructions on how to register for the correct training, can be found on the IRB CITI Compliance Training webpage.

Who is required to take the CITI Training?

CITI training is required for anyone who will be directly responsible for study management, data collection, consent process, data analysis, transcription, participant recruitment, or follow-up. Step-by-step instructions on how to register for the correct training, can be found on the IRB CITI Compliance Training webpage.

Do I need to list a faculty advisor?

Only students are required to list a faculty advisor. Students must list their faculty advisor within their IRB application along with their advisor's CITI training. Faculty and staff members are not required to list a faculty advisor.

When would I need a letter of support?

A letter of support is only needed when data is being collected at another institution’s campus or at an outside organization.
Additionally, a letter of support is needed when requesting data from any CSUF department.

What needs to be included in a letter of support?

Letters of support must be on an official letterhead, indicate the date, signature of the appropriate official, and name of PI.

When do I need an assent form?

An assent form is required when a minor is being asked to participate in a study. Like a consent form, an assent form should be issued to minors so they can decide if they wish to participate in the study or not.

NOTE, all assent forms must also have a Parental Consent issued to the parent first. Additional information can be found on the IRB Basic Steps page.

For an Assent or Parental Consent template reference, click on the following link: CSUF Templates to access the "Step 2: Preparing your IRB (gathering your documents)" tab.

What do I include in my consent form?

For a template reference, click the following link: CSUF Informed Consent Templates to access the "Step 2: Preparing your IRB (gathering your documents)" tab.

A consent form should list the following:

Study
Title
HSR #
Researchers
Sponsor (if applicable)
Brief description of the primary purpose of the study
Overview of what participants will be asked to do
Risks and benefits
Clarify if the information will be kept anonymous or confidential
Costs or payments for participating
Contact information
Rights as a research study volunteer
Meaning of participants signature on the consent form
Statement of consent

How long will it take for my study to get approved?

Protocols that fall within the Exempt or Expedited category may take up to 10-15 business days from the initial submission date. For the studies that fall within the full committee review category, approval can take up to 6-8 weeks as the IRB meets once a month on the second Friday of each month, except in July.

When can I begin collecting data?

The collection of research may only begin after a CSUF IRB approval letter has been received. Until this approval letter has been received, you are not allowed to begin collecting data.

What action do I take once my study is complete?

When you have reached the end of your study, you should submit a closure submission request. Once closed studies are marked as finalized, they can no longer be modified. For additional guidance, access the step-by-step instructions for Cayuse IRB: Submitting a Closure Request.

Contact IRB

Questions about the IRB and CSUF policies and procedures regarding human subjects in research can be directed to:

CSUF IRB Chair
Dr. Matt Englar-Carlson, Professor
Department of Counseling
(657) 278-5062
mattec@fullerton.edu

CSUF IRB Vice Chair
Dr. Ioakim Boutakidis, Professor
(657) 278-8562
iboutakidis@fullerton.edu

Research Compliance Specialist
Mandie Claussen
Office of Research and Sponsored Programs
(657) 278-7719
Human Subjects: irb@fullerton.edu