IRB — Review Procedures
IRB Review Categories
All researchers intending to involve human subjects must submit documentation to the IRB Chair regarding their research question and methods. The IRB Chair will then determine what level of IRB review is needed for the application. The Chair, assigned committee member, or the entire board may review the research proposal and approve, make suggestions, request more information, or disapprove of the proposal.
Level I research presents no foreseeable risk to human subjects. Level I research often includes anonymous surveys.
Level II research involves only minimal risk to human subjects.
Level III research falls into at least one of the following categories:
- Presents more than minimal risk
- Is funded by federal grants
- Involves deception
- Involves subjects from a group awarded special protections (e.g., pregnant women, fetuses, infants, children, prisoners, or those with diminished cognitive capacity).
Review Procedures
The IRB requires a complete application and relevant supporting documents no later than thirty (30) days prior to the intended start date of the research, unless otherwise stated in this document (such as in the case of the summaries submitted for in-class projects). Applications are acknowledged by email to the PI (and the PI's supervisor if the PI is a student) upon submission.
Level I applications are usually exempt from a full IRB review. The chair (or a designated alternate) will review Level I applications. Level I applications are typically reviewed within a week of submission.
Level II applications can be expedited, meaning that the chair and one other member of the IRB will perform the review. Level II applications are typically reviewed within two weeks of submission.
Level III research requires evaluation by a quorum (fifty percent plus one) of the IRB. Level III applications are reviewed within a month of submission.
The IRB committee generally acts by consensus; if consensus cannot be reached, the committee decides in favor of the majority opinion. If the IRB is evenly split, the vice president for academic affairs will vote.
An approval letter will indicate that the PI should promptly report to the IRB any changes to the project's protocol or personnel, unanticipated problems, or adverse effects that the PI encounters in the process of completing the research.
Researchers whose applications are not approved will be provided with a list of the concerns cited by the IRB. Researchers will be invited to respond, revise, and resubmit their applications for a new review.