Understanding IRB Categories
Part 1 of the IRB Review Form is designed to determine if your proposed project is not research (e.g., quality improvement projects) or if your proposed study is research but does not include human subjects (e.g., archival studies on de-identified data).
If you are proposing research with human subjects, you will complete Part 2 of the IRB Review Form. Your answers to the questions will allow the IRB to determine if your proposed study is exempt, can be expedited, or will require full board review. Understanding these categories can be confusing to anyone who is not trained as an IRB reviewer. Most research conducted by the USU community is exempt (which means you will receive a determination letter), some are expedited, and few require a full board review.
Details about each category are covered in more detail in your CITI training and in the Standard Operating Procedure Manual for the IRB (section 700 of the USU Policy and Procedure Manual). However, some general examples are included here, along with a link for those interested in more details.
Not Human Subjects Research
Proposed activities that receive a determination of not human subjects research based on the federal definitions will receive a determination letter (see Figure 1 - IRB Decision Tree).
Exempt
Most research conducted by USU faculty and staff falls into the exempt category. It is important to understand what the term exempt means in this context. Exempt studies are not exempt from institutional policies or the requirements for ethical research. Exempt studies are so named because they are exempt from some, but not all, of the federal regulations. In order for a study to qualify for the exempt category, two things must be true:
1. There is no more than minimal risk to participants. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
2. The research falls into an exempt category. The most common exemption category within the USU community is Exemption 45 CFR 46.104(d)(2) and is described as research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
Exempt studies may require "limited IRB Review" (created in 2018) for research in which the primary risks relate to privacy and confidentiality. The purpose of limited IRB review is to reduce the administrative burden imposed by IRB review while also helping to ensure human subjects are appropriately protected.
Example of Exempt Research without limited review: A researcher collects data from an online survey (exempt category) about leaders' perceptions of effective mentoring (because this topic is not sensitive in nature and any disclosure of the participants' responses outside the research would not reasonably place the participants at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation limited review is not required). More details: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html
Expedited
Occasionally, a study will fall into the expedited category. The term expedited does not mean the review is less rigorous or happens quickly. It refers to a type of research. Expedited research is research that requires IRB oversight and must be approved rather than simply receiving a letter of determination (see Figure 1 - IRB Decision Tree).
In order for the study to qualify for the expedited category, two things must be true:
1. There is no more than minimal risk to participants. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
2. The research falls into an expedited category (see Policy 700-22 for more details).
Examples in this category are typically irrelevant for USU faculty and staff. However, one category that may occur is research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies, when this research is not exempt.
Full Board Review
Studies that are not exempt or eligible for expedited review require a full board review and must be reviewed at a convened meeting of the IRB. Full board review involves research that collects sensitive information (covered in the Sensitive Topics section) and/or targets vulnerable populations (covered in the Vulnerable Populations section) but also includes minimal risk research that does not meet criteria specified in the exempt/expedited categories (see links above). Full board reviews take time, and if you believe your research will fall into this category, contact the IRB at IRB@usuniversity.edu as early as possible for guidance.
Regardless of the level of review, every investigator will go through the IRB process and receive an official letter from the IRB with the appropriate disposition. As a reminder: absolutely no recruitment of participants, data access, data collection, or implementation of your project or study may occur prior to IRB review and instruction to proceed with implementation.