The IRB review process
Your research will require IRB review if it is research that involves the collection of data from human subjects and aligns with the following definitions:
- “Research means a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” 45 CFR 46. 102(d)
- “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual or, (2) identifiable private information.” 45 CFR 46.102(f)
Step 1: Application – faculty, staff and students who are planning research projects involving human subjects are responsible for beginning the IRB review process by emailing the IRB proposal form for request of approval for human subjects research to Deborah Sheren at firstname.lastname@example.org.
Step 2: Review – Your proposal will be assigned to one of three review categories: Level 1 – Exempt Review (no foreseeable risks), Level 2 – Expedited Review (minimal risk), and Level 3 – Full Board Review (more than minimal risk and protected subjects).
Exempt level of review
A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories outlined in 45 CFR 46.101(b). Briefly described, the categories most pertinent to the college include:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
- Research using anonymous or no-risk tests, surveys, interviews, or observations.
- Research involving the collection or study of existing data if it is publically available or if subjects cannot be identified.
- Research examining public benefit or service programs.
Most exempt level reviews are completed within two weeks after being received by the IRB.
Expedited level of review
Expedited involves review by the IRB chair and one or more experienced reviewers. Research may qualify for expedited review if it is considered to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. The full list of categories of research that may be reviewed as expedited can be found in 45 CFR 46.110.
Most expedited reviews are completed within approximately three weeks after being received by the IRB.
Full board review
A full board review is required for research that is not eligible for exempt or expedited review. Research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. The following categories of research require full IRB approval:
- Projects for which the level of risk is determined by the IRB Chair to be greater than minimal.
- Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
- Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals).
- Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).
Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process.
Outcomes of Review – There are four possible outcomes to a review:
- Approved – no further action is required from the investigator prior to initiation of the study.
- Approved with Changes – the investigator may initiate the study after IRB requested changes are made and the IRB receives these revisions and notifies the investigator that he or she may proceed.
- Revise and Resubmit – extensive changes are required before the study can begin. Additional information must be submitted to the IRB prior to approval.
- Denied – the proposed research cannot be initiated.
Continuing Review – Research approved by the IRB that is continuing must be re-reviewed annually.