Institutional Review Board
California Lutheran University's Institutional Review Board's (IRB) primary responsibility is to protect the rights, welfare, and privacy of all human participants in research conducted by California Lutheran University faculty, staff and students.
The IRB reviews all research studies involving human subjects for safety, compliance with regulations, and ethical standards. The IRB provides guidance and resources for students, faculty, staff and study team members.
Human Subjects Research Activities
All research activities at Cal Lutheran involving human subjects must receive IRB approval or be determined exempt from IRB review before any research activities involving human subjects may begin. Cal Lutheran investigators are expected to conduct human subjects research in an ethical manner in accordance with federal, state, and local regulations, institutional policy, and as described in the IRB approved or exempt certified protocol.
Please Note: Research activities involving human subjects cannot receive IRB approval or an exempt determination retroactively. Federal regulations allow for IRB approval only when it is prior to the initiation of the research activities.
IRB Review Process
All applications are processed on a rolling basis as they are submitted through Cayuse.
The Review Process involves several steps including submitting the application, determining the level of review needed (Exempt, Expedited, or Full Board), receiving feedback, and potentially amending the study before receiving approval. Please allow sufficient time for review. The length of time for review and approval depends on the type of human research, the level of risk, and the complexity of ethical or technical questions that arise during review.
Step 1: Pre-Review Process (approximately two (2) weeks)
The IRB office utilizes an initial pre-review screening process, during which the
IRB analyst reviews each submission for completeness and compliance. This can consist
of several rounds of comments, if necessary. IMPORTANT NOTE: The pre-review process does not include scientific or scholarly review.
Step 2: IRB Committee Member Review (approximately 4-6 weeks, at a minimum)
Once the pre-review process is complete and the submission has been determined to be Exempt or Expedited, it will be assigned to an IRB Committee Member for review. This can also include several rounds of comments from the reviewer. Each round of comments will re-start the overall review time.
Additional considerations that can affect the total review time:
Complexity of the study:
More complex studies, especially those involving vulnerable populations, sensitive topics or novel research, may require more extensive review and potentially longer timelines.
Quality of the application:
Well-prepared applications with clear instructions and complete documentation can expedite the review process. If the submission is not clear or lacking the necessary documentation, this will lead to more comments by the IRB Reviewer, which will extend the review time.
PI response time:
Prompt responses to the IRB's requests for clarification or changes can also help expedite the process.
IRB workload and meeting schedules:
Busy periods, like the end of the academic year or during holidays, may cause longer review times.
Please consider the following:
Start Early:
It's always advisable to submit your IRB application as soon as you have planned your research, allowing sufficient time for review and approval before your intended start date.
Plan for potential revisions:
Be prepared for the possibility that the IRB may require revisions or further information, which could extend the review timeline
Stay in communication:
Maintain open communication with the IRB throughout the review process to address any questions or concerns promptly
IRB Committee Meetings
Most applications can be reviewed by a member of the Committee; however, if an IRB Submission is determined to need Full Board Review, it will be reviewed at the next Committee Meeting with at least a two-week lead time. For example, if an application is submitted the week of a Committee Meeting and it is determined to need Full Board Review, it will get reviewed at the following meeting. Committee Meetings are typically held on a monthly basis. Please allow approximately eight (8) weeks for a Full Board Review.
Full Board Meeting Review Dates:
Summer 2025
To be scheduled as needed.
Health and Human Services (HHS) Regulations, Policy and Guidance
FWA# 00023488
IORG# 0005903
IRB#00007117