- Should I notify the IRB of amendments (changes) to a study even if it is considered “Exempt”?
- Answer: The IRB should be notified of any changes that are made to a study (including changes to PI/project lead or research personnel in addition to changes to study documents) even if a study is considered Exempt. Please notify the IRB prior to the implementation of any changes.
- What happens if there is disagreement with the IRB’s decision or stipulations?
- Answer: The IRB is here to help. If you have questions or concerns about our decision or stipulations, please contact us. There is no formal appeal process, but we can work with you to develop a successful application.
- What’s a DPH/DHS Liaison?
- Answer: A DPH/DHS liaison is a person who is responsible for a research project when the PI/project lead or Co-PI is not a permanent DPH or DHS employee. If the Principal Investigator/Project lead or Co-PI for a research study is not a permanent DPH/DHS employee, a DPH/DHS staff member will need to be designated as DPH/DHS liaison.
- Does the IRB review the science and methodology of a project?
- Answer: The IRB is obligated to consider the design and methods in terms of demands on the subjects and whether the research questions can be answered by the proposed methods.
- What level of IRB review is right for my project? What if I pick the wrong level?
- Answer: The level of IRB review is determined by the level of risk to participants. If the wrong level was selected, the IRB will correct the level of review and may ask the researcher to submit additional information.
- Is informed consent required for all research projects?
- Answer: Consent is generally required for all human subjects research except exempt projects. Signed consent can be waived for some situations. Elements of informed consent can be waived or altered if the IRB determines that the study meets criteria for “no more than minimal risk”. Please visit our forms and information page for more information.
- What is informed consent?
- Answer: “Informed Consent” for research is permission or approval from the participant. The required contents of a consent form are specified by federal regulation. Consent is more than just the form – it is an ongoing process that starts with the first contact and ends when the participant’s role in the study ends. Please visit our forms and information page for more information.
- Do I need approval from more than one IRB for a research project involving multiple locations?
- Answer: If multiple institutions are engaged in a research project an agreement can be enacted between the relevant IRBs so that only one IRB review is performed. The principal investigator (lead investigator/recipient of funding) must indicate in the IRB application the activities conducted at the other site(s). To discuss IRB review for your research, contact the IRB
- How long will it take to get IRB approval?
- Answer: IRB review is an iterative process. A typical IRB application undergoes multiple rounds of revisions before approval. The length of the process is impacted by the level of review, thoroughness of the application, and speed of responses from the applicant for information and edits requested by the IRB.
- Does the complexity of research determine how it is reviewed?
- Answer: No, the level of IRB review is primarily determined by the level of risk and the population under study. Populations such as children, prisoners, pregnant women and neonates require added protections per federal regulation. Other vulnerable populations, such as persons with impaired decision-making or persons experiencing homelessness, may require further scrutiny as well.
- Are all IRB applications reviewed by a committee?
- Answer: All IRB applications/submissions are reviewed initially by the IRB Vice Chair or an IRB analyst. The IRB Vice Chair or IRB analyst may issue exempt determinations. Expedited studies must be reviewed by both the IRB Vice Chair (or IRB analyst) and also by a member of the IRB committee. The minority of IRB submissions are reviewed by the “Full Board” at a committee meeting.
- How do I apply for IRB review?
- Answer: To submit a project for IRB review, the investigator and all study personnel must complete (or have completed within the last 3 years) either: 1) the human subjects protection course at www.citiprogram.org, or 2) the LACDPH IRB Human Subjects Protection Training. * When you are ready to submit an IRB application, click on https://lacdph.my.irbmanager.com/ to access the online system where you can submit your application. *Additional training requirements may apply, depending on the nature of the research project.
- Does an “Expedited” submission get a faster review?
- Answer: No, expedited is a level of review named and defined by federal regulation. It does not indicate speediness. The speed of an IRB review depends on the thoroughness of the application and the speed of responses from the applicant to information and stipulations requested by the IRB.
- Does “Exempt” mean IRB review is not needed?
- Answer: Researchers often interpret the word exempt to mean there is no IRB review needed. The level of review for a project is ultimately determined by the IRB. Studies that are designated as exempt must still undergo an initial IRB review, but they may not require further review (i.e. continuing review).
- What about student, volunteer, or intern projects?
- Answer: The IRB also reviews student, volunteer, and intern projects. For such projects, an experienced researcher who is a full-time DPH staff member will need to be named as Co-Principal Investigator.
- Does my project need IRB review?
- Answer: If your project entails research or any related activities, as defined below, please submit an application to the IRB for review. If you are still not sure whether your project needs IRB review, please contact the IRB. Research: (1) a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, or (2) a systematic collection or analysis of data with the intent to generate new knowledge. Related activities: any process that involves collecting or analyzing data from or about individuals other than that related to provision of clinical care or conducting statutorily mandated surveillance and disease or environmental investigation, including but not limited to 1) activities that may be considered "practice" or otherwise not research, 2) program evaluation, 3) quality assurance and improvement, 4) non-legally mandated surveillance, and 5) needs assessments.