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California State University, Long Beach
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CSULB Institutional Review Board

Under the regulations of the Food and Drug Administration (FDA), 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 in (to secure approval), or disapprove research. The priority mandate of the IRB is to protect human subjects from physical or psychological harm. It therefore serves an important role in the protection of the rights and welfare of human research subjects and is responsible for critical oversight functions for research conducted on human subjects that are 'scientific', 'ethical', and 'regulatory'.

In accordance with these regulations, and 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. To accomplish this purpose, the IRB reviews research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research conducted by or under the aegis of CSULB. All individuals intending to conduct research involving human subjects must have a project application approved by the IRB PRIOR to conducting their research.

 

The program for protection of human subjects of research at California State University Long Beach depends on each member of the community understanding the basic 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 positions are:

  • Respect
  • Beneficience
  • Justice
  • The IRB and all researchers must maintain complete respect for the autonomy of individuals and must understand and act appropriately in situations in which the autonomy of individuals is reduced by individual circumstances or constrained by the research process itself.
  • The IRB and all researchers must assure that the benefit of research outweighs the risks. To do so, it is necessary to look to the science for assurance that it is well-conceived.
  • The IRB and all researchers must assure that the costs and benefits of research are distributed equitably in the population. No category or group of persons shall be asked or required to bear an unfair burden of risk so that others may benefit.

All members of the University community are urged to become completely familiar with the Belmont Report. It is upon the first principles enunciated in the Report that all else is predicated. A mutual understanding of these principles is fundamental to the success of each research project.

IRB Preparation & Pre-requisites

  1. Is my project "Human Subjects Research" that requires IRB Review?

    1. What is Research?

    2. How is “Human Subject” defined?

  2. CSULB IRB Training

    As of September 1, 2013 IRB Training Certification must be done prior to IRB application submission by completing 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. What Protocol Review category does my research fall under (Administrative, Expedited or Full Board Review)?

  4. Should I use the Existing Human Subject Data Study Application Form?

  5. Do I need a Federal Certificate of Confidentiality?

 

The Application: Forms & Guidelines

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

  2. Instructions for Completing the IRB Application Forms

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

  4. IRB Application Form (Existing Human Subject Data Study) Microsoft Word Document [Also available from the Documents Library on IRBNet)

  5. Informed Consent Tempate Microsoft Word Document [Also available from the Documents Library on IRBNet)[R]

    1. Informed Consent Instructions

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

  7. 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.

  8. CSULB IRB Procedures

 

Submitting Your IRB Application

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.**

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 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.

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

 

Submission Process

  • As of July 2, 2012 all IRB applications must be submitted electronically through IRBNet. Hard paper copies of IRB application are no longer accepted

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

 

Application Revisions

                    N. FAQ: Making Revisions to your Application during Pre-Review Adobe PDF Document (Unlocked Packages)

                    O. FAQ: Making Revisions in Response to a “Request for Modifications” from the IRB

                          (Submitting a Subsequent  Packages Adobe PDF Document)

 

Modifications to an Active Approved Protocol

  • P. Protocol Modifications Microsoft Word 2007 Document [Also available from the Documents Library on IRBNet)[V] (Protocol Modifications should be submitted using the “Submitting Subsequent Packages” process. See Item M above.)

 

Renewals & Annual Reports - Continuing Review

  • Q. Annual Report and Renewal Application Microsoft Word Document [Also available from the Documents Library on IRBNet) [U] (Annual Reports and Renewals should be submitted using the “Submitting Subsequent Packages” process. See Item M above.)

 

Other Policy & Procedure Documents