Institutional Review Board (IRB) Requirements
IRB Requirements for Evidence-Based Practice and Quality Improvement Activities/Initiatives
What is the Institutional Review Board (IRB)?
The UCLA Office of the Human Research Protection Program (OHRPP) is charged with protecting the rights and welfare of human subjects participating in research by ensuring compliance with federal regulations, state laws, University policies and national standards as well as providing education, review and monitoring of research studies. The IRB is one of three units within the UCLA OHRPP that is responsible for review and approval of human subjects research performed by UCLA employees and students as defined by federal regulations for human subject protections (45 CFR 46.102(d)).
Is an IRB Determination Required for Evidence-Based Practice and Quality Improvement Initiatives?
UCLA Health Nurses implement a large number of Evidence-Based Practice/Quality Improvement (EBP/ QI) initiatives annually. Although many of these projects do not have “research intent,” it is important to ensure those projects with “research intent” are appropriately directed for IRB review and approval. Additionally, documentation of IRB determinations for EBP or QI projects may be required for journals, conferences, funding sources and other activities. The UCLA OHRPP/IRB recommends obtaining a formal “Review Not Required” determination for EBP/QI projects. The Research, Evidence-Based Practice, and Innovation Programs in the Center for Nursing Excellence and UCLA OHRPP worked in partnership to establish an efficient and user-friendly process to submit EBP/QI projects for this purpose. The online form will assist nurses in determining whether an EBP or QI project constitutes human subjects research pursuant to federal regulations or whether projects fall outside the purview of IRB.
How do I submit an application for an EBP or QI initiative to the IRB?
To submit an EBP/QI project to the IRB, you will complete a brief IRB Form for EBP/QI Activities.
Nurse investigators will be asked questions about the characteristics and activities of their project, including intent of project activities, project funding, and plans for dissemination. Based on the information provided on the form, nurse investigators will be informed via email that the project either:
- Does not appear to meet the definition of human subjects research that requires the submission of an IRB application to the UCLA OHRPP, or
- May be considered “research” and may require approval by the IRB prior to implementation.
Important Note: Determinations will not be provided for completed EBP/QI initiatives “retroactively.” The EBP/QI determinations should be sought prior to data collection and/or for the data analysis going forward.
Projects that may be considered research will be submitted to the IRB for determination. The IRB usually provides a response via email within seven to ten business days. Nurses are encouraged to keep IRB determinations for their records. The IRB does not maintain copies of your responses.
IRB Requirements for Student Projects
When a UCLA Health nurse is completing a project as a student to fulfill a course or program requirement at another academic institution, the UCLA Institutional Review Board (IRB) is not the IRB of Record for the project. UCLA would be considered a “Site.” Therefore, as a first step, student projects must be reviewed by the student’s academic institution IRB. The UCLA IRB will not provide a determination or documentation until the student’s academic institution IRB makes a determination first.
- If the student’s academic institution IRB determines that the project “does not to meet the definition of human subject research,” then please complete the brief IRB Form for EBP/QI Activities. Provide detailed information in each field and attach a copy of your academic institution IRB determination letter/notice. Your response will be reviewed.
Students should not collect any data or perform any project-related activities without permission granted by student’s academic institution and any other organization(s) involved in the project as a site.
- If the student’s academic institution IRB determines that the project is “research” and approves the research, then please 1) submit the “Administrative Review Form,” as per the form instructions to UCLA IRB and 2) send a copy to Jaehee Choi at [email protected]. The Center for Nursing Excellence documents the conduct of research as part of the requirement for the ANCC Magnet® Recognition Programs at Ronald Reagan UCLA Medical Center, UCLA Santa Monica Medical Center, and Resnick Neuropsychiatric Hospital at UCLA.
For questions and/or assistance, please contact Dr. Pamela Miller and Jaehee Choi at [email protected].
Guidance: Determining Which Activities Require UCLA OHRPP/IRB Review
Guidance and Procedure: Research Conducted by UCLA Students