Types of IRB Review
The Department of Health and Human Services federal regulations (45 CFR 46) define three types of IRB review. When submitting to the IRB, the VCU investigator makes the initial determination of what type of review a study may qualify for. Upon review of the research, the IRB makes the final determination.
The HHS and FDA regulations identify categories of research that are exempt from the regulations; although the ethical principles of study conduct still apply. Even though the research may be "exempt," at VCU the determination of exemption must be made by the IRB. Exempt projects are different from Expedited or Full Board review in that they are not assigned an expiration date, do not have to undergo continuing review and are able to be modified in most cases without IRB approval.
In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption, and it cannot place subjects at greater than minimal risk. If the research involves prisoners, then it does not qualify for exemption from federal regulations and IRB review.
Expedited review means that the review can be done by a single qualified IRB member rather than at a convened IRB meeting. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When reviewers cannot approve the research under expedited review, the study is referred for full board review.
To qualify for expedited review, research must be no greater than minimal risk and involve only procedures described by specific categories identified in the federal regulations.
Full Board Review
Full board review means that the research is reviewed at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. This type of review applies to studies that are greater than minimal risk, or minimal risk but do not qualify for exempt or expedited review.