If you plan to collect data for the purposes of evaluation or assessment only, IRB/ORIC review may not be required. Please see our HSR Roadmap page as a beginning point, or you can contact the Office of Research Integrity and Compliance (907-786-1099) or the IRB Chair to help make this determination. If you are conducting work with people or data about people, you will need to seek formal review or document that your work is Not Human Subjects Research with one of our Human Subjects Research Determination forms, and submit it on IRBNet.

The PI makes a preliminary determination of which category of review the activities require, but the IRB and ORIC make final determinations of which level of review applies to the research as part of the review process.

Exempt Review

For a Human Subjects Research study to qualify for an exemption, it must present minimal risks, if any, to subjects and fit one of the exemption categories. Here are some examples of exempt studies:

• Research involving normal educational practices in educational settings
• The use of educational tests, surveys, interview procedures, or observations of public behavior
• Benign behavioral interventions with adults
• Secondary data analysis where the investigator does not record identifiers
• Taste and food quality evaluation (foods without additives)

Limited IRB Review

A Limited IRB Review is used when a study would qualify for an exemption (exemptions 2 or 3), except the data are identifiable and present informational risks to subjects. In that case, the IRB can perform a review to ensure that there are adequate privacy and confidentiality measures in place to reduce the informational risks to no more than minimal risk. Some examples of studies requiring a Limited IRB Review:

• The use of educational tests, surveys, interview procedures, or observations of public behavior with adults where the data are identifiable and present informational risks to subjects
• Benign behavioral interventions with adults where the data are identifiable and present informational risks to subjects

Expedited IRB Review

The OHRP published a list of categories of research that can be reviewed by expedited review procedures, known as the Secretary’s List. These reviews include all the same criteria for approval as Full Board Review studies, but the review can be done outside of a convened meeting by one or more qualified IRB member(s).Only studies that present no more than minimal risk to subjects qualify. Examples of expedited studies:

• Surveys, Interviews, or Focus Groups involving subjects under age 18
• Collection or study of existing data, documents, or records in an identifiable format
• Qualifying collections of blood samples, biological specimens, or routine clinical practices involving certain kinds of physical sensors (see Secretary’s List for conditions)

Full Board Review

Examples of full board review studies:

• Any research that presents more than minimal risk to subjects
• Most Research on any kind of population vulnerable to coercion or undue influence, including individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
• Research involving pregnant women or fetuses
• Research involving prisoner subjects

If you know your project is Human Subjects Research and have specific questions about whether it is exempt, or requires limited IRB review, expedited review, or full board review, please contact the Research Compliance Office or the IRB Chair.