Institutional Review Board (IRB)

Any questions or help needed regarding CSULB IRB?  Please send an email to IRB@csulb.edu.

ANNOUNCEMENTS

1) IRB submission package requirement:

Based on the Feb 2022 IRB meeting decision - In order to speed up the protocol review process, please limit the number of documents attached in your application package. 

(a) New protocol submission should attach no more than three documents: (i) IRB Application Form, (ii) Informed Consent Form(s), (iii) Appendices (Please combine all items into this one file and list them in alphabetical order, e.g., Appendix-A: Recruitment flyer, Appendix-B: Permission Letter, Appendix-C: Faculty Advisor Letter, etc.)

(b) Amendment submission package should attach no more than four documents: (i) Amendment Form (also called Request for revisions to the approved IRB protocol), (ii) revised IRB Application Form, (iii) Informed Consent Form(s), (iv) Appendices (Please combine all items into this one file and list them in alphabetical order, e.g., Appendix-A: Recruitment flyer, Appendix-B: Permission Letter, Appendix-C: Faculty Advisor Letter, etc.)

(c) Response to requested modification submission package should attach no more than four documents: (i) Response Letter, (ii) revised IRB Application Form, (iii) revised Informed Consent Form(s), (iv) Appendices (Please combine all items into this one file and list them in alphabetical order, e.g., Appendix-A: Recruitment flyer, Appendix-B: Permission Letter, Appendix-C: Faculty Advisor Letter, etc.)

2) In order to better serve CSULB research community, the IRB office provides Virtual Office Hours via Zoom meetings, 2-3 pm, every Wednesday.  Please feel free to email IRB@csulb.edu to schedule the one-on-one Zoom consulting session with the IRB staff.   You will have an option to choose whether you allow the session to be recorded for follow-up purpose. 

3) IRB Response to COVID-19 Challenges, Phase-3

Please read the memo regarding CSULB IRB Response to COVID-19, Phase-3, and the IRB Guide for Projects with In-Person Procedures During the COVID-19 Pandemic Approved Nov 4th, 2021

4) Where to find/download the PDF versions and the Microsoft Word versions of the IRB Forms. 

In order to meet the requirements of CSU Accessible Technology Initiative (ATI) http://teachingcommons.cdl.edu/access/,  the PDF versions of the forms are posted in relevant sections of this IRB webpage, and the Microsoft Word versions can be downloaded from the IRBNet Library Manager.

 

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Library Manager

 

5) As of January 21, 2019 compliance for the revised Common Rule (also called the 2018 Rule,  adopted by 17 federal departments and agencies to regulate research with human subjects) is in effect. 

The goal of the Revised Common Rule is to better protect research subjects, reduce administrative burdens and streamline IRB processes. Many useful HHS OHRP educational resources and videos on the revised Common Rule can be found at https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html Please note that significant changes have been made, especially regarding the definition of Research, the definition of Human Subject, the Exemption Categories, and the Informed Consent form.  Only qualified CSULB IRB members/administrators are authorized to determine which project meets the definition of "Research with Human Subjects," and subsequently, whether an IRB protocol can be approved under a particular exemption category.  Investigators are not allowed to make self-determination on such topics.  

6) AY 2022-2023 IRB Meeting Dates, Submission Deadlines and Protocol Processing Timeframe: 

The IRB reviews protocol submissions on an ongoing basis throughout the academic year. The IRB conducts rolling reviews, so submissions can be made year-round, including summer and winter breaks. Majority of protocols meet the criteria for Administrative/Limited/Expedited Review, and there is no submission deadline for these types of protocols.  But you should consider submitting your protocol at least two months prior to your project initiation date. 

Only protocols with high risks need the IRB to conduct a Full-board Review at its meeting. In general, the IRB meeting date is the 2nd Thursday during the regular semesters.  The IRB typically does not meet during the summer or winter break.  In order for the IRB to have sufficient time to conduct full-board review at its meeting, please make sure that the entire protocol package including all relevant appendices with "reviewable" quality is submitted via IRBNet no later than the following deadline.  

AY 2022-23 Meeting Dates Sept 8, 2022 Oct 13, 2022 Nov 10, 2022 Dec 8, 2022 Feb 9, 2023 Mar 9, 2023 April 13, 2023 May 11, 2023

Submission Deadline

for Full Board Review

Aug 19, 2022 Sept 23, 2022 Oct 21, 2022 Nov 18, 2022 Jan 20, 2023 Feb 17, 2023 Mar 24, 2023 April 21, 2023

IRB always strives to improve its efficiency. Our goal is to approve protocols requiring full board review within  8 weeks (pending submission before the deadline specified above), and to approve protocols within 6 weeks when processed via Administrative/Limited/Expedited Review.  However, it takes a team effort to achieve this goal. The actual timeframe for a particular protocol really depends on many factors including (a) the availability of the IRB reviewer with particular expertise, (b) the quality, completeness and promptness of the investigator's submission/response, (c) the workload of IRB administrators, (d) the volume of protocol submission, etc.  Delay of submission/response, lack of sufficient information/appendices, low protocol quality, sudden protocol volume increase, and summer/winter break time are among the most common causes that lead to the delay of protocol review/approval.   For these reasons, students and faculty members are highly recommended/encouraged to consult with the IRB office to initiate the protocol preparation/submission process as EARLY as possible, in order to avoid a delay.  IRB Staff will work with you to make sure your application package is complete and of sufficient quality, for it to be "reviewable."  No research with human subjects is allowed prior to obtaining approval from the IRB. 

IRB Workshop Material

 

The CSULB IRB hosted a workshop, February 13, 2018 to discuss the IRB’s revised review and submission process. A lot of relevant questions were asked during the session and if you have questions about how the changes to the IRB forms and review process will affect your research, please review the video and download the attached PowerPoint slides to follow along. The video contains information about the changes in federal research regulation in addition to valuable guidance on filling out the forms and the review process timeline.

Please contact the IRB office if you have additional questions