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CSULB Institutional Review Board (IRB)


CHANGES AHEAD

We are making significant changes to our forms and processes in response to new federal regulations.  These changes must be implemented before the end of the year.

Eventually, these changes should simplify the IRB process, but you should anticipate serious delays during the transition period.

Click Here For IMPORTANT DEADLINES


Who We Are

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.

Attention First Time Applicants

  • If you are a Student Applicant click here for more information on submitting an IRB Application
  • Faculty, Staff, External PIs and all others click here.

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. Please submit your project at least three weeks prior to your planned start date.


IF YOU HAVE SUBMITTED AN APPLICATION OR REVISIONS/ MODIFICATIONS TO IRBNET AND YOU HAVE NOT RECIEVED A RESPONSE AFTER TWO (2) WEEKS PLEASE DO THE FOLLOWING:

  1. Check to make sure that you hit the "Submit This Package" Button in the left hand nav bar.  If a package is showing as "Work in Progress" in the Project History page it has not been sent to us yet.
  2. CONTACT US and ask about the status of the application. There are three ways to contact us:
    1. Email us using the "Send Project Mail" Button in IRBNet
    2. Email us at irb@csulb.edu
    3. Call (562) 985-8147 and ask to speak to an IRB Administrator

 

 Deadlines & Processing Schedule

All submission will undergo an administrative pre-review before being assigned an review category and submitted the IRB for official review.

Review Category

Schedule*

Standard

(Full Board)

Projects involving more than minimal risk are reviewed by the entire IRB (Full Committee or Standard Review) at its monthly meeting on the 2nd Thursday of every month during the semester.  Projects requiring Full Committee Review must be received by the IRB Office no later than the last Friday of the preceding month to be placed on the agenda for the following month's meeting.

For example to ensure placement on the agenda for the October meeting we must received your submission no later than the last Friday in September.

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

Expedited

Projects that involve minimal risk are reviewed by a sub-commitee of two IRB members.

Administrative

Projects involving less than minimal risk are processed by an IRB Administrator.

Getting Started with a Protocol (Show/Hide)

Click the video below to learn how to submit your project to IRBNet (online submission platform).  The video also includes helpful guidance for completing the IRB Application.

Video - Using IRB

How to Submit an IRB Application at CSULB

IRB Protocol Review Pre-requisites (Show/Hide)
 1. Complete CITI Training

    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.

    Instructions on How to Sign up for CIT

2. Submit an IRB Protocol: Follow steps below:

    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.

3. 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)

    Research Determination Form (Quality Assessment/Quality Improvement Study)

     

    Other Considerations
    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.

     

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

    RESEARCH INVOLVING EXISTING HUMAN SUBJECT DATA

    IRB Application Form (Existing Human Subject Data Study)  [Also available from the Documents Library on IRBNet)

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 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 in the package the protocol application form and any supporting documents. These should reflect the requested modifications.

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 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

Reporting an Unanticipated/Adverse Event (Show/Hide)
The researcher is instructed to inform the IRB Office in writing (email is acceptable) within twenty-four hours of any adverse event in the conduct of research involving human subjects. The report shall include the nature of the event, the names of the persons affected, the extent of injury or breach of security, if any, and any other information material to the situation. Please email ORSP Compliance at ORSPCompliance@csulb.edu  to make a report.
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 Rachel Ho via email at Rachel.Ho@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).

  • Proof of CITI training.
  • Recruitment tools (e.g. flyers, emails, brochures).

*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