Institutional Review Board (IRB)
The CSULB Institutional Review Board (IRB) is responsible to ensure that all research projects involving human subjects are conducted in compliance with federal, state, and local regulations to protect the research participants.
If you have any IRB-related questions, concerns, or queries, please send an email to IRB@csulb.edu.
To find the most up-to-date Word versions of IRB forms, templates, and sample documents, please log into IRBNet and look under Forms and Templates. IRBNet Guide
This section will provide guidance for student researchers new to research involving human subjects on preparing an IRB application. Those who plan to conduct research in disciplines not typically associated with human subjects (e.g., engineering, computer programming, etc.) should consult their departments for guidance.
For Student/Program Projects, please refer to the IRB Guidance on Student Projects (PDF) and IRB Umbrella Protocol for Administrative Review (DOC).
Pre-Preparation of IRB Application
1. CITI Training
Complete CITI training via CITI Program. For further information, refer to Instructions on Navigating CITI Program (DOC).
2. Faculty Advisor/Mentor
To review student researcher responsibilities, refer to What is a Student Researcher?
To review Faculty Advisor/Mentor responsibilities, refer to Guidance for Faculty Advisor.
3. IRBNet
Submit your IRB application via IRBNet. Please refer to the IRBNet Guide for instructions on how to create an account and navigate the system.
Preparation of IRB Application
4. Which IRB Application should I use?
For research involving secondary data analysis, use the IRB Application for Existing and Secondary Data Form (DOC).
For minimal risk research involving one of the following exempt categories, use the IRB Application for Exempt Review (DOC).
For minimal risk research where the exempt categories do not apply and the research falls under one of the following expedited categories, use the IRB Application for Expedited and Standard Review (DOC). Note: Greater than minimal risk research that is not eligible for exempt or expedited will undergo Standard Review by the convened IRB. Refer to AY 2024 - 2025 Meeting Dates and Submission Deadlines for Greater than Minimal Risk Research (PDF).
5. What should I include with my IRB application submission?
- Application materials are to be organized as displayed below:
(i) IRB Application Form
(ii) Informed Consent Form(s)
(iii) Appendices (compile all items into one file, listed alphabetically, e.g., Appendix-A: Recruitment flyer, Appendix-B: Permission Letter, etc.)
- Faculty Advisor Letter: For student researchers named as PI, verification of supervision by a faculty member is required. Faculty Advisor Template (DOC)
- Interview questions and/or survey questions. Please provide a copy of the interview protocol and/or survey, and provide an active link for online surveys. If there are screening questions to determine participants' eligibility, please explain what will happen to the screening data for those not eligible for the study.
- Permission/Authorization Letters: When conducting research off-campus or in locations other than the researcher's office/lab or public space, the IRB requires the submission of permission/authorization letters. Sample Permission Letter (PDF)
- Recruitment Material: Recruitment Material Guidance
- Consent Notice: Informed Consent Template
- Parent Permission Form: When recruiting minors, please provide a Parent Permission Form.
Assent Form: When recruiting minors, please provide an assent form.
6. What are the possible outcomes of an IRB review?
The IRB has three application forms for New Project submissions. Read below to determine which form you need to complete for your research. Please refer to the IRBNet Guide for instructions on online submissions.
For research involving secondary data analysis:
IRB Application for Existing and Secondary Data Form (formattable) (v.3).docx
For minimal risk research activities involving one of the following exempt categories:
IRB Application for Administrative and Limited Review (formattable) (v.3).docx
IRB Application for Exempt Review (BETA).docx
For research activities involving one of the following expedited categories:
IRB Application for Expedited and Standard Review (formattable) (v.3).docx
For Student/Program Projects (Please read the Guidance on Student Projects first to see whether your project meets the submission requirements for Umbrella Project):
IRB Guidance on Student Projects Feb13_2020 (PDF)
IRB Umbrella Protocol for Administrative Review (DOC)
Before submitting to the IRB please confirm the following:
- Application materials are organized as displayed below...
(a) New Project Submission
1. IRB Application Form
2. Informed Consent Form(s)
3. Appendices (compile all items into one file, listed alphabetically, e.g., Appendix-A: Recruitment flyer, Appendix-B: Permission Letter, etc.)
(b) Revision Submission (Response to requested modification letter)
1. Cover Letter (Outlining revisions)
2. Revised IRB Application Form
3. Revised Informed Consent Forms(s)
4. Appendices (compile all items into one file, listed alphabetically, e.g., Appendix-A: Recruitment flyer, Appendix-B: Permission Letter, etc.)
- CITI Training: Completed CITI online training viawww.citiprogram.org.The IRB requires all individuals listed on New Project to complete either the Social & Behavioral Basic/Refresher Course or Biomedical Research - Basic/Refresher.
Instructions on Navigating CITI Program (PDF)
- Permission/Authorization Letters: When conducting research off-campus or in locations other than the investigator's office/lab or public space, the IRB requires the submission of permission/authorization letters.
View a sample permission letter (PDF)
| Campus Body | Campus Recruitment Contacts |
|---|---|
| Student Life & Development (posting, recruiting and tabling in common areas on campus) | Request a permission letter addressed to the CSULB IRB |
Institutional Research & Assessment (large student data sets for secondary data analysis) | https://csulb.qualtrics.com/jfe/form/SV_b8x522380f4NZ8V The IR&A collects and analyses data, and generates reports to support institutional planning. Areas of interest include admissions, enrollment, retention and persistence rates, as well as time-to-degree and graduation rates broken down by student type (i.e. freshmen, transfers etc.). To request IR&A data submit the Data Request Form at the link above. If you are requesting identifiable data or data with links to identifiers such as emails or student ID #s, the IRB requires a permission letter from IR&A included with your IRB submission. |
| Individual Courses or Entire Departments | Request permission letter(s) from individual instructors or Department Chairs (when recruiting from the entire department by posting flyers) and list all courses or areas you will have permission to recruit. (Ex. Psy. 446 & 447 or Psychology Department bulletin boards). |
- Faculty Advisor Letter: For student investigators named as PI, the IRB requires research supervision by faculty member.
- Online Survey: If your research involves an online survey, please provide the URL.
- Consent Notice: Informed Consent Guide Template
- Parent Permission Form: When recruiting minors, please provide a parent permission form.
- Assent Form: When recruiting minors, please provide an assent form.
- Recruitment Material: Recruitment Material Template
Please refer to the IRBNet Guide for instructions on submitting a subsequent package.
Amendments: The Request for Amendment to an Approved IRB Protocol form is for changing your approved research such as adding/changing personnels, number of participants, informed consent, questions to survey, or recruitment site, etc. Please provide any additional documents that are affected by the proposed changes, highlighted, and submit the documents as a subsequent package to your approved research in IRBNet.
Annual Protocol Check-Ins: If active recruitment or outstanding research-related activities are continuing, please complete the Annual Check-In form.
Annual Check-In Form (v.3).docx
Continuing Reviews: Only research that underwent Standard Review (reviewed by the convened IRB) at the initial review, OR research was escalated to greater than minimal risk due to amendments to approved research will complete a Continuing Review form.
Continuing Review Form (v.3).docx
Serious Adverse Event (SAE) and Serious Unanticipated Problem (SUP): SAE or SUP occuring in projects overseen by the CSULB IRB should be reported within 5 business days. Any life-threatening event or problem should be reported within 24 hours to IRB@csulb.edu.
Serious Adverse Event / Serious Unanticipated Problem Report.docx
- IRB Submission
- Upload documents to IRBNet
- Include all relevant attachments
- Pre-Review
- Confirms completeness
- Recommend Revisions
- IRB Review
- Administrative
- Exempt
- Expedited
- Full Board
- Modification Letter
- Mandatory changes requested based on ethics and compliance
- Final Review & Approval
- Project approved after all modifications are adequately addressed
