Institutional Review Board (IRB)

IRB Handbook 

The IRB Handbook has been prepared to help researchers navigate the process of preparing and submitting proposed research to the IRB. Compiled in this handbook is all of the most up to date policies and procedures, and the steps necessary to move through the IRB process.

IRB Submissions

Each researcher is required to complete ethics training. Biola offers free ethics training through Citi Program. You will need to click on the right-hand search bar to register, then follow the instructions for IRB researcher. All researchers are required to complete the Responsible Conduct of Research, and Human Subjects Research (Social Behavioral Educational Researchers), these certificates of completion will be electronically issued. Certification is good for 3-years from the date of completion and must accompany your application.

In addition, a three-level structure has been established for the approval of research projects involving human participants. More detail is given in the protocol guidelines.

Level I: Proposals for research that presents no risk to participants (see Section 11.0) are eligible for exempt review. Reviews of exempt proposals will be conducted by the IRB Chair or an IRB member appointee. Very few proposals will fall into this category.

Level II: Proposals for research involving minimal risk may be eligible for expedited review. These proposals will be reviewed by the Chair or one or more IRB member appointee(s).

Level III: Proposals for research involving more than minimal risk or studies involving vulnerable populations (a disparity in power exists between the researcher and the participants) or sensitive topics will be subject to a full review by the IRB committee during a monthly meeting. This process will typically take 4 weeks. Below is the schedule for the following semester, all paperwork for full board reviews must be submitted at least 10 days prior to the next scheduled meeting for review.

Fall 2024 Semester Full Board Reviews:

• September 10
• October 8
• November 12
• December 10

Please Note: Submissions for Full Board Reviews received after the deadline for the final meeting of each semester may not receive approval until the following semester. Exempt and Expedited reviews are ongoing throughout the year. IRB does not review any submissions during the month of July.

Guidelines and Forms for Qualified Research

All qualified research must go through Biola's IRB. The application should be carefully filled out and submitted electronically to administrative staff at the Office of Academic Research and Grants (OARG) at irb@biola.edu and also cc your director/chair if applicable. Research proposals are generally processed within four to six weeks of submission. However, the researchers should leave additional time for unanticipated delays: Biola holidays, the end of each term, or for the review of requested revisions to the protocol.

Here are some examples of the types of studies that may fall under Level I exempt category:

• Data collection for internal departmental, school, or other University administrative purposes. Examples: teaching evaluations, customer service surveys.
• Service surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University or for developing new services or programs for students, employees, or alumni, as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained, and survey participation is voluntary. This would include surveys by professional societies or University consortia. Note: If the data are planned to contribute to generalizable knowledge, then IRB approval is required. The IRB does not provide approval after data has already been collected, so researchers must plan ahead and anticipate the need for IRB oversight.
• Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Examples: canvassing librarians about inter-library loan policies or periodical purchases or interviews with company engineers or managers about how a product is made.
• Course-related activities designed specifically for educational or teaching purposes, where data are collected as part of a class exercise or course requirement, but are not intended for use outside of the classroom. Note: thesis and dissertation projects do not fall under this category. If you are not sure if your project meets this definition, contact the IRB at irb@biola.edu prior to beginning the project.
• Biography research involving a living individual that is not generalizable beyond that individual.
• Research involving cadavers, autopsy material or biospecimens from deceased individuals. Note: Some research in this category, such as genetic studies providing private or medical information about live relatives, may need IRB review.
• Studies strictly using publicly available data. Examples: census data, labor statistics. Investigators should contact the IRB if they are uncertain as to whether the data qualify as publicly available.
• Coded private information or biological specimens that were not collected for the currently proposed projects do not need IRB review as long as the investigator cannot link the coded data/specimens back to individual subjects. If the data/specimen provider has access to the identity of the subjects (e.g. subjects’ names, addresses, etc.), the investigator must enter into an agreement with the data/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator. Note: Investigators cannot independently make this determination. These projects require verification from the IRB Chair or their designee.

Clear guidelines can be found in the IRB Handbook.