Types of Review
There are several types of review during the IRB process, including exemptions, expedited reviews, and full reviews. In the course of a review, an application may be:
- determined to be Exempt
- approved through an Expedited review process
- sent back to the principal investigator (PI) for modifications
- approved by the full committee
- referred to a higher level of review
- denied (full reviews only).
In all cases, reasons will be given for the action so the PI may make necessary changes for resubmission or modification.
For multi-year projects requiring continuing review, researchers must resubmit their projects for approval each year. Investigators must also resubmit when the level of risk for human subjects changes for an approved protocol.
Exemptions
Exemptions can be granted for research studies that meet specific criteria. Usually, these are for very low-risk studies. If you believe that you might qualify for an exemption, you must still complete an IRB application and request the exemption. Failure to request the exemption, even if it turns out that you are entitled to the exemption, would be considered noncompliance. No data collection can begin until the IRB officially grants the exemption.
Section 45 CFR 46.104 of the Code of Federal Regulations (CFR) provides Categories of Exemption where research may be exempted from regular IRB review. Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the Exemption Categories are exempt from the requirements of 45 CFR 46, except that such activities must comply with the requirements of 45 CFR 46.104 and as specified in each category.
Additional considerations may be needed, or may not allow for an exemption, for study populations such as pregnant women, prisoners, and children.
Expedited Reviews
If you do not qualify for an exemption, it may still be possible to have your review expedited before considering review at a convened IRB meeting. It is important to note that the standard for expedited review and the materials that you will submit are the same as for a full review. The only difference is that the expedited review is done by a single member of the IRB outside of a full review, typically on a faster timetable when compared to a full review.
Expedited review is available for studies that involve minimal risk. The Code of Federal Regulations defines minimal risk as meaning that 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.
The US Department of Health and Human Services provides descriptions of categories for types of research that can qualify for an expedited review.
Full Reviews
Research protocols that are not eligible for either an exemption or expedited review will be placed on the agenda for the next convened meeting of the IRB. A quorum of committee members must be present for the committee to vote. All committee members review each protocol placed on the agenda for the convened meeting unless a member has a conflict of interest. The committee then discusses the protocol and votes for approval, modification, tabling the review for another meeting pending the receipt of additional information, or disapproval.
Deadlines
Requests for Full IRB Committee Review
The IRB deadline for submission of materials for research involving human subjects that require a full review of the IRB is the first of the month for September, October, November, December, February, March, and April. The IRB generally will respond to submissions for a full review within a few weeks after the submission deadline. If there is a request for a full committee review in the summer or during Winter Break, members will conduct the review if available. Please contact the IRB Chair during these periods in advance if you plan on a request for a full review.
Requests for an Exemption or an Expedited Review
Requests for an exemption or an expedited review typically receive an initial response within 7 to 10 days after submission.
Timetables for typical exemption requests that are approved are typically 2 to 3 weeks, while typical expedited reviews can take anywhere from 2 to 4 weeks to receive approval. These timetables are dependent on the time of year, the volume of requests being reviewed by the IRB, investigator response time, how much information the IRB requires, etc.
International Research
Due to the complexities of international research, the IRB recommends that researchers planning to conduct international research submit their studies at least three months prior to the anticipated start date of their study.