The purpose of the Institutional Review Board (IRB) at The College of Saint Scholastica (CSS) is to provide initial and continuing review of all research activity involving humpan participants. The IRB's main aim is to ensure that the safety and rights of research participants is protected. The CSS IRB is registered with the Office of Human Rights Protections and follows the guideliens for reviewing all research provided in the Code of Federal Regulations for the Protection of Human Subjects, (CFR 45 Part 46).
Types of Review
The CSS IRB has three main ways to review applications for research: full-board; expedited; and exempt. The links below are intended to provide information that will help researchers determine which type of review their research activity is likely to need. The type of review is based mainly on the level of risk for human participants. The Federal Regulations have defined the term minimal risk as "the probability and magnitude of harm or discomfort anticipated in the research 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" (CFR 45 Part 46.102). In general, research activity with risk to subjects that is greater than minimal risk receive full-board review, while studies with minimal risk receive expedited review. Some research activity qualifies for exempt review; this means that the risk is low, but the researcher must still submit an application to ensure that the activity qualifies for one of the approved exemptions under the Federal Regulations.
Rules for Exempt Review
Rules for Expedited Review
Rules for Full Review
For more Federal Guidelines, visit: www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html