Mission Statement
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.
Health and Human Services (HHS) Regulations, Policy and Guidance
https://www.hhs.gov/ohrp/regulations-and-policy/index.html
Guidance for Changes Needed to Currently Approved Research Studies
We understand that there are times 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 must complete the following checklist and submit to the IRB at irb@callutheran.edu for review. This form can also be found under the Researchers tab. While your study was determined Exempt, the IRB Committee would still like to review the proposed changes to make sure that the risk to subjects still remains "no more than minimal risk".
If the study was approved under an Expedited category or by the Full Board, then the study team will need to complete and submit Modification Form HRP-213 (Researchers Tab), along with the specific changes, 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), please contact the IRB Committee at irb@callutheran.edu.
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.
PLEASE NOTE: The IRB cannot retroactively provide an approval or Exempt determination for a study that has already been conducted. Classroom projects do not meet the definition of "research" as defined by the Federal Regulations and are not intended for dissemination outside the institution.
IRB Committee Members
IRB Committee Meeting Dates
Note: All applications are processed on a rolling basis and in the order that they are received. 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.
March - TBD
April 11, 2023
May 2, 2023
To report a concern please email the IRB at the email address noted below. Otherwise, if you would like to make an anonymous report, please use the following link:
https://www.callutheran.edu/offices/human-resources/resources/conduct-hotline.html
Contact Information
- IRB Committee
irb@callutheran.edu - Monica Gracyalny, PhD, Assoc. Professor, Communications
Director, Research Protections Office & IRB Chair
mgracyal@callutheran.edu - Leigh Schectman, IRB Coordinator
lschectman@callutheran.edu
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: irb@callutheran.edu.