Guidance for Changes Needed to Currently Approved Research Studies:
During this time, we understand that many of you may need to make certain changes in order to continue with your research study and have questions of whether or not you need to submit these changes to the IRB Committee. Studies that were granted an Exempt determination can make changes without submitting to the IRB so long as those changes do not increase the risk for participants. If the risk for participants is more than minimal, this would bump the study up to an Expedited review. If, however, the study was approved under an Expedited category or by the Full Board, then the study team will need to submit a modification to the IRB for approval before they can implement the desired changes. Once the IRB approves the modification, the study team is free to implement the changes to their protocol.
It is important for Investigators to know the review pathway of their protocol before moving forward (i.e. exempt, expedited, or full board). New studies that were reviewed in the last several months should have an approval letter (expedited) or an exemption letter on file.
If study teams are not sure of their review determination (exempt/expedited) or are not sure if any changes that need to be made might impact the original determination, please contact the IRB Committee at firstname.lastname@example.org.
Please also know that the IRB Committee is still working remotely and reviewing studies via email, per our previous procedures.
"California Lutheran University's Institutional Review Board's (IRB) primary responsibility is to protect the rights, welfare, and privacy of all individuals participating in research sponsored by Cal Lutheran. 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, and study team members."
Researchers can now access the necessary forms/templates by clicking on the "Researchers" tab to the right.
Training information can be accessed by clicking on the "Training and Educational Resources" tab to the right.
Classroom Research Project Information (New Class Policy as of Spring 2020):
California LutheranUniversity has implemented a new policy for human subjects research undertaken by student investigators for the sole purpose of obtaining course credit (projects involving human subjects research in Psychology, Research Methods, Exercise Science, etc.). Classroom Research Projects that meet certain requirements may be excluded from review and approval by the Cal Lutheran IRB. In such cases, no forms or documents need to be submitted to the IRB. The faculty/instructors take full responsibility for overseeing the project and assuring ethical principles are adhered to in the conduct of the project’s activities. The complete list of requirements for Classroom Projects can be found in the new Classroom Research Projects Policy (Checklist) below.
IRB Committee Members
(List of members coming soon)
IRB Committee Meeting Dates:
March 17, 2020 (Cancelled)
April 21, 2020
May 19, 2020
IRB Committee email@example.com
Grady Hanrahan, PhD, Assoc. Provost - Experiential Learning, Chemistry Professor firstname.lastname@example.org
Monica Gracyalny, PhD, Assoc. Professor - Communications & IRB Chair email@example.com
Leigh Schectman, IRB Coordinator firstname.lastname@example.org
This website will be continually monitored to make sure we provide the most accurate and up to date information. If you have any questions, please email the IRB Committee at: email@example.com.