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CSULB Institutional Review Board (IRB)

Who We Are

Under the regulations of the Food and Drug Administration (FDA) and the Department of Health and Human Services (specifically Office for Human Research Protections), an Institutional Review Board (IRB) is an appropriately constituted group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. The IRB has the authority to approve, require modifications, or disapprove research.

At CSULB the IRB is composed of faculty, staff and non-affiliated community members. All IRB members have considerable expertise in a discipline associated with research involving humans. The IRB reviews faculty and student research, as well as other research conducted on campus by non-affiliated investigators.

Why We Exist

Under the assurance provided by CSULB to the Department of Health and Human Services (HHS) in accordance with HHS regulations [45 CFR part 46], the purpose of the CSULB IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

How We Do It

The IRB reviews research protocols (IRB applications) and supporting materials (e.g., informed consent documents and investigator brochures) for the applicability of federal policy. The IRB review focuses on ethical considerations which underlie not only the federal guidelines but the campus assurance of compliance. These ethical principles are stated in the "Belmont Report". The three basic ethical principles are:

Respect: “Individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.”

Beneficence: “(1) do not harm and (2) maximize possible benefits and minimize possible harms.”

Justice:  “The sense of "fairness in distribution" or "what is deserved.”

During the protocol review, the IRB will look for these principles to be applied in the informed consent, risk/benefit assessment, and the selection of subjects of research ( CSULB IRB Procedures).

Announcements

  • April 2016- The CSULB IRB has updated the IRB application form. Please make sure to fill out the most current version (Version 04/06/2016).
  • For the last full board meeting of the spring semester will be on May 12, 2016. Applications for the May 12th full board review need to be submitted by April 29th. The IRB does expedited and administrative reviews in the summer but standard (full board reviews) are only done on an emergency basis.

IRB Protocol Review Pre-requisites (Show/Hide)

All investigators (whether professional or student) intending to conduct research involving human subjects must have a project application (IRB protocol) approved by the IRB PRIOR to conducting their research.

Investigators must first determine if their project falls under the category of research by answering the following question:

  • Is my project "Human Subjects Research"?

Investigators need to be aware that research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Per regulations, “Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the person, or (2) identifiable private information.”

YES, my project falls under the definition of human subject research- You will need to obtain submit a protocol to obtain IRB approval prior to conducting research. Please follow the Getting Started with a Protocol instructions below.

My project involves existing Human Subject Data- Research which involves the production of and/or initial collection of data, records, information, specimens, etc. from the human subjects themselves requires application for formal review. Please follow the Getting Started with a Protocol instructions. You will have to submit an IRB Application for Use of Existing Human Subject Data. In some cases, IRB application may not be required, as detailed in the first two items of this form. If IRB application is required for studies using existing human subject data only, the application will be reviewed via administrative review.

NO, my project does not fall under the definition of human subject research- Thank you for taking the time to make sure that your project is conducted with integrity and compliance. Your project does not require IRB approval. Please contact the Human Subjects Compliance Specialist if you still have any concerns.

Getting Started with a Protocol (Show/Hide)

Now that you have reviewed the IRB protocol Review Pre-Requisites and have determined that your project requires IRB approval, please follow the instructions below:

  1. Complete CITI Training
  2. As of September 1, 2013 ALL INVESTIGATORS (PIs) and KEY PERSONNEL who are assisting with the research must complete the "Social & Behavioral Research - Basic/Refresher” course offered by CITI (Collaborative Institutional Training Initiative). Access to the CITI training is free provided by the Office of Research and Sponsored Programs.

    If you were IRB Certified using the CSULB Training Modules before September 1, 2013, that Certification remains valid until August 31, 2016. You do not have to complete the CITI course until the expiration of that certification.

  3. Submit an IRB Protocol: Follow steps A-D
  4. A. Visit IRBNetresources.org and view the IRBNet Training Resources using the following credentials:

    Username: csulb

    Password: training1

    When you have finished the training, visit IRBNet to register and create IRBNet account.

    Be sure that the "irbnet.org" domain is identified as a "Safe Sender" in your email program. Otherwise important communications could get caught in your Junk Mail filter.

    B. Determine what type of review your protocol falls under

    There are three categories for review by the IRB under which researchers must choose to submit their application. These categories relate the nature and the level of potential risk to the subject. The investigator must select one of the applicable review categories. However, the IRB will make the final determination during the pre-review of the protocol according to a risk assessment.

    Standard Review

    Expedited Review

    Administrative Review

    Any protocol deemed inappropriate for a given category will be transferred by the Office of University Research to the appropriate category.

    If your study will use existing human subject data only, please refer to the IRB Application Form (Existing Human Subject Data) In some cases, IRB application may not be required, as detailed in the first two items of this form. If IRB application is required for studies using existing human subject data only, the application will be reviewed administratively

    C. Fill out and upload the following documents on to your IRB Net package (as applicable):

    • RESEARCH INVOLVING HUMAN SUBJECTS

    IRB Application Check List Microsoft Word Document [Also available from the Documents Library on IRBNet)

    Instructions for Completing the IRB Application Form

    IRB Application Form Microsoft Word Document [Also available from the Documents Library on IRBNet)

    Informed Consent Template Microsoft Word Document [Also available from the Documents Library on IRBNet)

    Child Assent Template

    Informed Consent Instructions

    Faculty Supervisor's Statement Template Microsoft Word Document [Also available from the Documents Library on IRBNet)

    Do I need a Federal Certificate of Confidentiality

    Online Surveys: In your application be sure to provide the URL (web address) for all online surveys. If you are using Qualtrics please view these instructions to ensure that your survey allows participants to de-select or unanswer a question. IRB requires that participants have the option of not answering a question.

    ***MAKE SURE TO UPLOAD THE CITI RECORD FOR ALL KEY PERSONNEL INVOLVED IN THE RESEARCH ON TO YOUR IRBNet PACKAGE.

    • RESEARCH INVOLVING EXISTING HUMAN SUBJECT DATA

          D. Plan your time project timeline wisely!

During certain periods of the academic year, the number of protocols received and other factors may cause delays in processing. However, every attempt is made to stay as close to this timetable as possible. Investigators must also keep in mind that the IRB may require modifications to a protocol in order to secure approval.

                    Deadlines & Processing Schedule

Review Category

Schedule*

Standard

(Full Board)

Applications received by the IRB Office by the last Friday of the preceding month are agendized for the next monthly meeting on 2nd Thursday of month. Agendas and application materials sent to all IRB members approximately 10 days prior to meeting. Outcomes of meeting reviews sent to researcher within 5 working days after meeting by IRB Office.**

Standard reviews do not occur during the summer or winter terms.

Expedited

Applications sent to subcommittee within 2 working day of receipt by the IRB Office. Subcommittee (2 members) reviews and reports determination within 5 working days to IRB Office.  Determinations sent to researcher within 5 working days after review.

Administrative

Applications sent to Administrator within 2 working day of receipt by IRB Office. Administrator reviews and reports determination within 2 working days of receipt to IRB Office. Determinations sent to researcher within 2 working days after review.

 

During the Review of a Protocol (Show/Hide)

After a protocol has been submitted, the following process will take place:

IRB Process Map

To respond to revisions requests during pre-review, please follow these instructions    (Unlocked Packages)

To respond to modifications required letter during Administrative, Expedited or Full review, please follow these instructions submitting a Subsequent Packages 

Submitting a Modification to an Existing Protocol (Show/Hide)

To submit modifications to an existing and approved protocol, fill out the Protocol Modifications Microsoft Word 2007 Document [Also available from the Documents Library on IRBNet)and upload it on to IRB net as a subsequent package to your existing package (Instructions to Submitting a Subsequent Packages)

Be sure to include all applicable supporting documents that the modification might affect.

Sumitting a Protocol Renewal (Annual Reports - Continuing Review) (Show/Hide)

Reports and Renewals should be submitted using the “Submitting Subsequent Packages” process. Please fill out the Annual Report and Renewal Application Microsoft Word Document [Also available from the Documents Library on IRBNet) and upload it on to the subsequent package of your protocol. (Instructions to Submitting a Subsequent Packages).

CSULB IRB Policies (Show/Hide)

Other Policy & Procedure Documents

Unaffiliated PIs (Show/Hide)

If you are a PI affiliated with an institution other than CSULB and you are not collaborating with a CSULB PI but wish to recruit participants from CSULB for your research, submit the following documents to Nelly Hernandez via email at Nelly.Hernandez@CSULB.edu:

  • Consent Form approved by your home institution IRB.

  • IRB Approval Letter from your home institution.

  • Permission letter from the CSULB department that you wish to recruit participants from (e.g. Department of Psychology Psychology Subject Pool).

*Note: For permission to recruit in-person or post flyers on campus, please contact the Student Life & Development at Studentlife@CSULB.edu

FAQs (Show/Hide)
          1. Is my study considered anonymous or confidential?

Please read the recommendations (click here) made by our sister campus Cal Poly Pomona to distinguish between an anonymous or confidential study.

2. How long does my approval last?

Following federal regulations, the CSULB IRB grants approval for one year. Please visit the Submitting a Protocol Renewal tab for more information on renewing your protocol.

3. How can I test the consent form I am going to give to participants to make sure it is at an appropriate reading level?

You can test the consent form by inserting only the text of the document into a readability calculator, like: http://www.readabilityformulas.com/flesch-grade-level-readability-formula.php 

4. How big should my study's sample size be?

             A statistician or your faculty advisor should be able to help you in defining your sample size. You         can also visit this website (Creative Research Systems) in order to better understand determining an appropriate       sample size for your research