Human Subjects: Introduction
This brief listing of often-asked questions and their answers is designed to help you understand the necessity of working with the Institutional Review Board (IRB). Any research projects involving human subjects must be approved by the IRB before the research is initiated.
I have heard that if I do research using human subjects I need to have approval from somebody. Is that true?
Yes, it is true. The Institutional Review Board (IRB) for Human Studies at La Sierra University (LSU) needs to review and approve each project in which human subjects are involved. This is a University-wide policy and applies to everyone who is in any way associated with the University or using University property for their research.
But doesn’t this IRB approval only apply to medical research that involves stuff like needles, blood and/or drugs?
No. IRB approval needs to be obtained for all studies where human subjects are involved. This also applies to studies that involve surveys and questionnaires.
Won’t this slow up the whole process of class projects and create a lot of confusion?
Any La Sierra University investigator conducting or directing research on human subjects using any property or facility of the University needs to have approval by the IRB. This includes students. If, as part of a class, questionnaires are filled out by class members only, IRB approval is not needed. If, however, you want to question non-class members, you must have IRB approval. An IRB review should be approached as a part of the learning process, since it is an accepted and required part of human research in the professional and academic domains.
But, I don’t like people telling me how to do my research.
The IRB is only concerned with protection of human subjects and compliance with Federal guidelines formulated by the Department of Health and Human Services, Title 45 Part 46 of the Code of Federal Regulations (45CFR 46). The IRB will make recommendations to assure subject rights, minimize risks to subjects, and guarantee appropriate informed consent for the subjects in the study. The IRB does not judge or comment on the design or intellectual content of the project.
Can I start a project and then get IRB approval after I have collected the data?
No. The application to the IRB is part of the proposal and approval must be in place before data collection begins. If you are currently conducting research on human subjects without IRB approval, you are out of compliance with university policy. In this case, promptly contact the IRB office for direction.
What can the IRB do to me if I choose to bypass IRB approval?
The IRB does not expect to be a policing force. It is University policy that compliance is required if you are going to use human subjects in your research. Appropriate action to prevent unauthorized studies will be pursued.
What do I need to do to have my studies with human subjects approved by the IRB?
You may contact the chairperson of the IRB and request the application form or download it from the web-site. You then need to fill this form out and return it, along with all required documents and signatures, to the IRB chairperson. As you will see, this form determines the level of subject risk. Depending upon that risk level, the IRB requests certain documentation so that it can properly evaluate your application.
How long will the approval process take?
At present, the IRB meets on a monthly schedule during the 9-month academic year. If your research meets the “exempt” criteria set up by the IRB, then approval may be granted by the IRB chairperson before a meeting has been held. Furthermore, an expedited approval may be given by the IRB chair, if there are no serious questions about your proposal. Of course, for many proposals an official meeting is necessary, and you may be asked to attend to answer specific questions in more detail. Final approval of all proposals is voted at the monthly IRB meetings.
Applications for IRB approval are due to the IRB chairperson (Leslie Martin, Ambs Hall #105) by the 3rd Wednesday of each month.
Contact the IRB at (951) 785-2454 or at firstname.lastname@example.org.